Lung Cancer, Non-Small Cell
Conditions
Keywords
NRAS, docetaxel, NSCLC, GSK1120212, MEK inhibitor, targeted therapy, KRAS, BRAF
Brief summary
This is a phase II, open-label, multicenter, randomized study to evaluate the efficacy and safety of GSK1120212 compared with docetaxel in the second line setting for subjects with locally advanced or metastatic (Stage IV) Non-small cell lung cancer (NSCLC) harboring a KRAS mutation who have failed one platinum-containing chemotherapy regimen. A small subset of NSCLC subjects harboring BRAF, NRAS, or MEK1 mutations will be randomized in addition to the primary KRAS population, for exploratory purposes.
Interventions
DRUGGSK1120212
Oral once daily
DRUGdocetaxel
IV once every 3 weeks
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* At least 18 years old with histologically- or cytologically-confirmed diagnosis of adenocarcinoma Stage IV NSCLC with a positive mutational status for the KRAS, NRAS, BRAF, or MEK1 gene. * Documented tumor progression after receiving at least one, but not more than one, prior approved platinum-containing chemotherapy regimen for advanced stage/metastatic NSCLC. * Measurable disease per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. * Performance status score of 0 or 1 according to the Eastern Cooperative Oncology Group (ECOG) scale. * Able to swallow and retain orally administered medication and does not have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels. * Life expectancy of at least three months in the opinion of the investigator. * Women of childbearing potential must have a negative serum pregnancy test within 14 days of randomization to study treatment and agree to use effective contraception. Men with a female partner of childbearing potential must have either had a prior vasectomy or agree to use effective contraception from the time of randomization to study medication until at least four weeks after the last dose of study treatment. * Adequate baseline organ function.
Exclusion criteria
* History of another malignancy. * Any serious and/or unstable pre-existing medical disorder, psychiatric disorder, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures. * Treatment with a BRAF or MEK inhibitor or docetaxel as monotherapy or as part of a combination regimen. * Anti-cancer therapy (including chemotherapy and radiation therapy) within the last three weeks. * History or current evidence / risk of retinal vein occlusion or central serous retinopathy. * Any current or history of tumor manifestation in the Central Nervous System. * History or evidence of cardiovascular risk, including QTcB \>=480 msec, uncontrolled arrhythmias, acute coronary syndrome, coronary angioplasty, or stenting within 6 months prior to randomization, \>=Class II congestive heart failure, treatment refractory hypertension, intra-cardiac defibrillators or permanent pacemakers or cardiac metastases. * Known Human Immunodeficiency Virus, Hepatitis B Virus (HBV), or Hepatitis C Virus (HBC) infection (with the exception of chronic or cleared HBV and HCV infection).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS) as Assessed by the Investigator (INV) | From randomization (RAN) until the earliest date of documented radiological disease progression (PD) or death (DT) due to any cause (maximum of 10.2 months) | PFS is defined as the time from RAN until the earliest date of documented radiological PD or DT due to any cause. PD was assessed by the INV according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. PD is defined as at least a 20% increase in the sum of the diameters (SD) of target lesions with an absolute increase of at least 5 millimeters (mm) or the appearance of at least 1 new lesion, or the worsening of non-target lesions significant enough to require study treatment discontinuation. For participants (PAR) who did not have a documented date of PD or DT, PFS was censored at the date of the last adequate assessment. For PAR who received subsequent anti-cancer therapy prior to the date of documented PD or DT, PFS was censored at the date of the last adequate assessment prior to the initiation of therapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Crossover Phase | Baseline; Days 1, 8, and 15 of Cycle 1; and Day 1 of every cycle thereafter until treatment discontinuation of the Crossover Phase (up to Study Week 19) | Clinical chemistry parameters were summarized according to NCI CTCAE grade, version 4.0. Grade (G) 1, Mild; Grade 2, Moderate; Grade 3 (G3), Severe; Grade 4 (G4), Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to any grade, Grade 3, or Grade 4 occurred. Clinical chemistry parameters included: albumin, alkaline phosphatase (ALKP), alanine amino transferase (ALT), aspartate amino transferase (AST), total bilirubin, calcium (hypercalcemia), calcium (hypocalcemia), creatine kinase, creatinine, glucose (hyperglycemia), glucose (hypoglycemia), potassium (hyperkalemia), potassium (hypokalemia), sodium (hypernatremia), and sodium (hyponatremia). Worst-case on-therapy changes from Baseline were summarized. Worst-case on-therapy was defined using the on-therapy window and changes were indentified using both scheduled and unscheduled assessments. |
| Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Hematology Parameters: Randomized Phase | Baseline; Days 1, 8, and 15 of Cycle 1; and Day 1 of every cycle thereafter until treatment discontinuation of the Randomized Phase (up to Study Week 40) | Hematology parameters were summarized according to NCI CTCAE grade, version 4.0. Grade (G) 1, Mild; Grade 2, Moderate; Grade 3 (G3), Severe; Grade 4 (G4), Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to any G (IAG), G3, or G4 occurred. Hematology parameters included: haemoglobin (increased \[inc\]), haemoglobin (anemia), lymphocyte count (ct) (inc), lymphocyte ct (decreased \[dec\]), total absolute neutrophil count (ANC), platelet ct, and white blood cell count (WBC). Worst-case on-therapy changes from Baseline were summarized. Worst-case on-therapy was defined using the on-therapy window and changes were indentified using both scheduled and unscheduled assessments. |
| Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Hematology Parameters: Crossover Phase | Baseline; Days 1, 8, and 15 of Cycle 1; and Day 1 of every cycle thereafter until treatment discontinuation of the Crossover Phase (up to Study Week 19) | Hematology parameters were summarized according to NCI CTCAE grade, version 4.0. Grade (G) 1, Mild; Grade 2, Moderate; Grade 3 (G3), Severe; Grade 4 (G4), Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to any G (IAG), G3, or G4 occurred. Hematology parameters included: haemoglobin (increased \[inc\]), haemoglobin (anemia), lymphocyte count (ct) (inc), lymphocyte ct (decreased \[dec\]), total absolute neutrophil count (ANC), platelet ct, and white blood cell count (WBC). Worst-case on-therapy changes from Baseline were summarized. Worst-case on-therapy was defined using the on-therapy window and changes were indentified using both scheduled and unscheduled assessments. |
| Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Clinical Chemistry Parameters: Randomized Phase | Baseline; Days 1, 8, and 15 of Cycle 1; and Day 1 of every cycle thereafter until treatment discontinuation of the Randomized Phase (up to Study Week 40) | Data are presented for only those clinical chemistry parameters for which the following worst-case on-therapy changes from Baseline with respect to the normal range were observed: decrease to low, change to normal (CTN) or no change, or increase to high. Clinical chemistry parameters included: lactate dehydrogenase, total protein, and urea/blood urea nitrogen (BUN). Worst-case on-therapy changes from Baseline were summarized. Worst-case on-therapy was defined using the on-therapy window and changes were indentified using both scheduled and unscheduled assessments. Normal ranges for each parameter may vary depending on the laboratory (central versus local) and the participant (age, gender, etc.). |
| Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Clinical Chemistry Parameters: Crossover Phase | Baseline; Days 1, 8, and 15 of Cycle 1; and Day 1 of every cycle thereafter until treatment discontinuation of the Crossover Phase (up to Study Week 19) | Data are presented for only those clinical chemistry parameters for which the following worst-case on-therapy changes from Baseline with respect to the normal range were observed: decrease to low, change to normal (CTN) or no change, or increase to high. Clinical chemistry parameters included: lactate dehydrogenase, total protein, and urea/blood urea nitrogen (BUN). Worst-case on-therapy changes from Baseline were summarized. Worst-case on-therapy was defined using the on-therapy window and changes were indentified using both scheduled and unscheduled assessments. Normal ranges for each parameter may vary depending on the laboratory (central versus local) and the participant (age, gender, etc.). |
| Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Randomized Phase | Baseline; Days 1, 8, and 15 of Cycle 1; and Day 1 of every cycle thereafter until treatment discontinuation of the Randomized Phase (up to Study Week 40) | Data are presented for only those hematology parameters for which the following worst-case on-therapy changes from Baseline with respect to the normal range were observed: decrease to low, change to normal (CTN) or no change, or increase to high. Hematology parameters included: atypical lymphs, atypical lymphs (percentage \[%\]), basophils, eosinophils, metamyelocytes, monocytes, myelocytes, neutrophil bands (%). Worst-case on-therapy changes from Baseline were summarized. Worst-case on-therapy was defined using the on-therapy window and changes were indentified using both scheduled and unscheduled assessments. Normal ranges for each parameter may vary depending on the laboratory (central versus local) and the participant (age, gender, etc.). |
| Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Crossover Phase | Baseline; Days 1, 8, and 15 of Cycle 1; and Day 1 of every cycle thereafter until treatment discontinuation of the Crossover Phase (up to Study Week 19) | Data are presented for only those hematology parameters for which the following worst-case on-therapy changes from Baseline with respect to the normal range were observed: decrease to low, change to normal (CTN) or no change, or increase to high. Hematology parameters included: atypical lymphs, atypical lymphs (percentage \[%\]), basophils, eosinophils, metamyelocytes, monocytes, and myelocytes. Worst-case on-therapy changes from Baseline were summarized. Worst-case on-therapy was defined using the on-therapy window and changes were indentified using both scheduled and unscheduled assessments. Normal ranges for each parameter may vary depending on the laboratory (central versus local) and the participant (age, gender, etc.). |
| Number of Participants With Any Serious Adverse Event (SAE) or Non-serious Adverse Event (AE): Randomized Phase | From randomization until 30 days following discontinuation of study treatment regardless of initiation of a new cancer therapy or transfer to hospice (maximum of 19 months) | An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Medical or scientific judgment should have been exercised in deciding whether reporting was appropriate in other situations. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs. |
| Number of Participants With Any SAE or Non-serious AE: Crossover Phase | From the date of the first dose of study treatment in the Crossover Phase until 30 days following discontinuation of study treatment regardless of initiation of a new cancer therapy or transfer to hospice (maximum of 12 months) | An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Medical or scientific judgment should have been exercised in deciding whether reporting was appropriate in other situations. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs. |
| Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase | Baseline; Days 1, 8, and 15 of Cycle 1; and Day 1 of every cycle thereafter until treatment discontinuation of the Randomized Phase (up to Study Week 40) | Clinical chemistry parameters were summarized according to National Cancer Institutes (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade, version 4.0. Grade (G) 1, Mild; Grade 2, Moderate; Grade 3 (G3), Severe; Grade 4 (G4), Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to any G, G3, or G4 occurred. Clinical chemistry parameters included: albumin, alkaline phosphatase (ALKP), alanine amino transferase (ALT), aspartate amino transferase (AST), total bilirubin, calcium (hypercalcemia), calcium (hypocalcemia), creatine kinase, creatinine, glucose (hyperglycemia), glucose (hypoglycemia), potassium (hyperkalemia), potassium (hypokalemia), sodium (hypernatremia), and sodium (hyponatremia). Worst-case on-therapy changes from Baseline were summarized. Worst-case on-therapy was defined using the on-therapy window and changes were indentified using both scheduled and unscheduled assessments. |
| Change From Baseline in SBP and DBP: Crossover Phase | Baseline; Days 1, 8, and 15 of Cycle 1; and Day 1 of every cycle thereafter until treatment discontinuation of the Crossover Phase (up to Study Week 19) | Systolic and diastolic blood pressure were measured at the following scheduled time points: Baseline; Days 1, 8, and 15 of Cycle 1 (Study Week 1); and Day 1 of every cycle therafter until treatment discontinuation. The worst-case on-therapy was determined using both scheduled and unscheduled assessments during the on-therapy period. Change from Baseline was calculated as the value at post-Baseline time point minus the value at Baseline. |
| Change From Baseline in Heart Rate: Randomized Phase | Baseline; Days 1, 8, and 15 of Cycle 1; and Day 1 of every cycle thereafter until treatment discontinuation of the Randomized Phase (up to Study Week 40) | Heart rate was measured at the following scheduled time points: Baseline; Days 1, 8, and 15 of Cycle 1 (Study Week 1); and Day 1 of every cycle therafter until treatment discontinuation.The worst-case on-therapy was determined using both scheduled and unscheduled assessments during the on-therapy period. Change from Baseline was calculated as the value at post-Baseline time point minus the value at Baseline. |
| Change From Baseline in Heart Rate: Crossover Phase | Baseline; Days 1, 8, and 15 of Cycle 1; and Day 1 of every cycle thereafter until treatment discontinuation of the Crossover Phase (up to Study Week 19) | Heart rate was measured at the following scheduled time points: Baseline; Days 1, 8, and 15 of Cycle 1 (Study Week 1); and Day 1 of every cycle therafter until treatment discontinuation.The worst-case on-therapy was determined using both scheduled and unscheduled assessments during the on-therapy period. Change from Baseline was calculated as the value at post-Baseline time point minus the value at Baseline. |
| Number of Participants With a Best Response of Either a Complete Response (CR) or Partial Response (PR) as Assessed by the Investigator: Randomized Phase | From randomization until the first documented evidence of a CR or PR (maximum of 10.2 months) | Response was assessed by the investigator according to RECIST, version 1.1, using confirmed and unconfirmed responses. Responders were defined as participants achieving either a CR (disappearance of all target and non-target lesions; any pathological lymph nodes must be \<10 millimeters \[mm\] in the short axis; without the appearance of new lesions) or PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters \[e.g., percent change from Baseline\]). Participants with unknown or missing response were treated as non-responders. |
| Number of Participants With a Best Response of Either a CR or PR as Assessed by the Investigator: Crossover Phase | From the date of the first dose of study treatment in the Crossover Phase until the first documented evidence of a CR or PR (maximum of 4 months) | Response was assessed by the investigator according to RECIST, version 1.1, using confirmed and unconfirmed responses. Responders were defined as participants achieving either a CR (disappearance of all target and non-target lesions; any pathological lymph nodes must be \<10 millimeters \[mm\] in the short axis; without the appearance of new lesions) or PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters \[e.g., percent change from Baseline\]). Participants with unknown or missing response were treated as non-responders. |
| Duration of Response (DOR) as Assessed by the Investigator: Randomized Phase | Time from the first documented evidence of CR or PR until the earliest date of documented radiological progression or death due to any cause (maximum of 10.2 months) | DOR was assessed by the investigator for participants with CR (disappearance of all target and non-target lesions; any pathological lymph nodes must be \<10 mm in the short axis; without the appearance of new lesions) or PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters \[e.g., percent change from Baseline\]). DOR is defined as the time from the first documented evidence of CR or PR until the earliest date of documented radiological progression or death due to any cause. PD is defined as at least a 20% increase in the sum of the diameters (SD) of target lesions with an absolute increase of at least 5 millimeters (mm) or the appearance of at least 1 new lesion, or the worsening of non-target lesions significant enough to require study treatment discontinuation. |
| Overall Survival (OS) | Time interval between the date of randomization and the date of death due to any cause (maximum of 22 months) | OS is defined as the interval of time between the date of randomization and the date of death due to any cause. For participants who did not die, OS was censored at the date of last contact. |
| GSK1120212 Plasma Pharmacokinetic (PK) Concentration | Day 15 of Cycle 1: pre-dose; 0.5-2 hours, 2-4 hours, and 4-8 hours post-dose; Day 1 of Cycle 2, Cycle 3 and Cycle 4: pre-dose | Blood samples for PK analysis of GSK1120212 were collected at the following time points: Cycle 1 (Study Day 15), Cycle 2 (Study Day 22), Cycle 3 (Study Day 43), and Cycle 4 (Study Day 64). Post-dose PK samples collected on Day 15 of Cycle 1 occurred at least 1 hour apart. Participants were instructed to withhold the dose of GSK1120212 until after blood for PK samples had been drawn. Pre-dose samples were taken 15 minutes or less prior to taking the next dose (i.e., trough). |
| Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Randomized Phase | Baseline; Days 1, 8, and 15 of Cycle 1; and Day 1 of every cycle thereafter until treatment discontinuation of the Randomized Phase (up to Study Week 40) | Systolic and diastolic blood pressure were measured at the following scheduled time points: Baseline; Days 1, 8, and 15 of Cycle 1 (Study Week 1); and Day 1 of every cycle thereafter until treatment discontinuation. The worst-case on-therapy was determined using both scheduled and unscheduled assessments during the on-therapy period. Change from Baseline was calculated as the value at post-Baseline time point minus the value at Baseline. |
Countries
France, Greece, Hungary, Italy, Netherlands, South Korea, Spain, United States
Participant flow
Recruitment details
Participants who met eligibility criteria at Screening were then randomized to the treatment period. A total of 134 participants were randomized, and 130 participants entered the treatment period.
Pre-assignment details
In the Randomized Phase (RP), participants were treated until disease progression (PD), death, or unacceptable adverse events were experienced. After PD in the RP, participants were given the option of crossing over to the alternative treatment arm in a Cross-over Phase (CP).
Participants by arm
| Arm | Count |
|---|---|
| GSK1120212 2 mg in RP Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared \[mg/m\^2\]), and continuing in the Cross-over Phase (CP). | 89 |
| Docetaxel 75 mg/m^2 in RP Participants received docetaxel 75 mg per meters squared (m\^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP. | 45 |
| Total | 134 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Crossover Phase | Adverse Event | 0 | 0 | 4 | 0 |
| Crossover Phase | PD including Death due to PD | 0 | 0 | 16 | 1 |
| Crossover Phase | Study Closed/Terminated | 0 | 0 | 1 | 0 |
| Crossover Phase | Withdrawal by Subject | 0 | 0 | 2 | 1 |
| Randomized Phase (RP) | Adverse Event | 20 | 4 | 0 | 0 |
| Randomized Phase (RP) | PD including Death due to PD | 56 | 28 | 0 | 0 |
| Randomized Phase (RP) | Physician Decision | 1 | 9 | 0 | 0 |
| Randomized Phase (RP) | Study Closed/Terminated | 8 | 1 | 0 | 0 |
| Randomized Phase (RP) | Withdrawal by Subject | 2 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | GSK1120212 2 mg in RP | Docetaxel 75 mg/m^2 in RP | Total |
|---|---|---|---|
| Age, Continuous | 61.4 Years STANDARD_DEVIATION 8.97 | 60.9 Years STANDARD_DEVIATION 10.06 | 61.2 Years STANDARD_DEVIATION 9.32 |
| Race/Ethnicity, Customized African American/African Heritage | 3 Participants | 0 Participants | 3 Participants |
| Race/Ethnicity, Customized Asian - East Asian Heritage | 11 Participants | 9 Participants | 20 Participants |
| Race/Ethnicity, Customized Asian - South East Asian Heritage | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Missing | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White - Arabic/North African Heritage | 1 Participants | 3 Participants | 4 Participants |
| Race/Ethnicity, Customized White - White/Caucasian/European Heritage | 73 Participants | 32 Participants | 105 Participants |
| Sex: Female, Male Female | 43 Participants | 22 Participants | 65 Participants |
| Sex: Female, Male Male | 46 Participants | 23 Participants | 69 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 87 / 87 | 43 / 43 | 20 / 23 | 1 / 2 |
| serious Total, serious adverse events | 32 / 87 | 9 / 43 | 12 / 23 | 1 / 2 |
Outcome results
Primary
Progression-Free Survival (PFS) as Assessed by the Investigator (INV)
PFS is defined as the time from RAN until the earliest date of documented radiological PD or DT due to any cause. PD was assessed by the INV according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. PD is defined as at least a 20% increase in the sum of the diameters (SD) of target lesions with an absolute increase of at least 5 millimeters (mm) or the appearance of at least 1 new lesion, or the worsening of non-target lesions significant enough to require study treatment discontinuation. For participants (PAR) who did not have a documented date of PD or DT, PFS was censored at the date of the last adequate assessment. For PAR who received subsequent anti-cancer therapy prior to the date of documented PD or DT, PFS was censored at the date of the last adequate assessment prior to the initiation of therapy.
Time frame: From randomization (RAN) until the earliest date of documented radiological disease progression (PD) or death (DT) due to any cause (maximum of 10.2 months)
Population: Modified Intent-to-Treat (MITT) Population: all randomized participants with KRAS mutation-positive non-small cell lung cancer (NSCLC), whether or not treatment was administered
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| GSK1120212 2 mg in RP | Progression-Free Survival (PFS) as Assessed by the Investigator (INV) | 11.7 Weeks |
| Docetaxel 75 mg/m^2 in RP | Progression-Free Survival (PFS) as Assessed by the Investigator (INV) | 11.4 Weeks |
p-value: 0.519795% CI: [0.75, 1.75]Log Rank
Secondary
Change From Baseline in Heart Rate: Crossover Phase
Heart rate was measured at the following scheduled time points: Baseline; Days 1, 8, and 15 of Cycle 1 (Study Week 1); and Day 1 of every cycle therafter until treatment discontinuation.The worst-case on-therapy was determined using both scheduled and unscheduled assessments during the on-therapy period. Change from Baseline was calculated as the value at post-Baseline time point minus the value at Baseline.
Time frame: Baseline; Days 1, 8, and 15 of Cycle 1; and Day 1 of every cycle thereafter until treatment discontinuation of the Crossover Phase (up to Study Week 19)
Population: Crossover Population. Only participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GSK1120212 2 mg in RP | Change From Baseline in Heart Rate: Crossover Phase | 8.5 Beats per minute | Standard Deviation 11.46 |
| Docetaxel 75 mg/m^2 in RP | Change From Baseline in Heart Rate: Crossover Phase | 5.0 Beats per minute | — |
Secondary
Change From Baseline in Heart Rate: Randomized Phase
Heart rate was measured at the following scheduled time points: Baseline; Days 1, 8, and 15 of Cycle 1 (Study Week 1); and Day 1 of every cycle therafter until treatment discontinuation.The worst-case on-therapy was determined using both scheduled and unscheduled assessments during the on-therapy period. Change from Baseline was calculated as the value at post-Baseline time point minus the value at Baseline.
Time frame: Baseline; Days 1, 8, and 15 of Cycle 1; and Day 1 of every cycle thereafter until treatment discontinuation of the Randomized Phase (up to Study Week 40)
Population: Safety Population. Only participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GSK1120212 2 mg in RP | Change From Baseline in Heart Rate: Randomized Phase | 10.4 Beats per minute | Standard Deviation 14.23 |
| Docetaxel 75 mg/m^2 in RP | Change From Baseline in Heart Rate: Randomized Phase | 13.2 Beats per minute | Standard Deviation 9.31 |
Secondary
Change From Baseline in SBP and DBP: Crossover Phase
Systolic and diastolic blood pressure were measured at the following scheduled time points: Baseline; Days 1, 8, and 15 of Cycle 1 (Study Week 1); and Day 1 of every cycle therafter until treatment discontinuation. The worst-case on-therapy was determined using both scheduled and unscheduled assessments during the on-therapy period. Change from Baseline was calculated as the value at post-Baseline time point minus the value at Baseline.
Time frame: Baseline; Days 1, 8, and 15 of Cycle 1; and Day 1 of every cycle thereafter until treatment discontinuation of the Crossover Phase (up to Study Week 19)
Population: Crossover Population. Only participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK1120212 2 mg in RP | Change From Baseline in SBP and DBP: Crossover Phase | DBP, Worst-case on-therapy | 8.3 mmHg | Standard Deviation 12.28 |
| GSK1120212 2 mg in RP | Change From Baseline in SBP and DBP: Crossover Phase | SBP, Worst-case on-therapy | 8.7 mmHg | Standard Deviation 15.95 |
| Docetaxel 75 mg/m^2 in RP | Change From Baseline in SBP and DBP: Crossover Phase | SBP, Worst-case on-therapy | -15.0 mmHg | — |
| Docetaxel 75 mg/m^2 in RP | Change From Baseline in SBP and DBP: Crossover Phase | DBP, Worst-case on-therapy | -12.0 mmHg | — |
Secondary
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Randomized Phase
Systolic and diastolic blood pressure were measured at the following scheduled time points: Baseline; Days 1, 8, and 15 of Cycle 1 (Study Week 1); and Day 1 of every cycle thereafter until treatment discontinuation. The worst-case on-therapy was determined using both scheduled and unscheduled assessments during the on-therapy period. Change from Baseline was calculated as the value at post-Baseline time point minus the value at Baseline.
Time frame: Baseline; Days 1, 8, and 15 of Cycle 1; and Day 1 of every cycle thereafter until treatment discontinuation of the Randomized Phase (up to Study Week 40)
Population: Safety Population. Only participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK1120212 2 mg in RP | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Randomized Phase | SBP, Worst-case on-therapy | 13.5 millimeters of mercury (mmHg) | Standard Deviation 16.63 |
| GSK1120212 2 mg in RP | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Randomized Phase | DBP, Worst-case on-therapy | 10.7 millimeters of mercury (mmHg) | Standard Deviation 9.95 |
| Docetaxel 75 mg/m^2 in RP | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Randomized Phase | SBP, Worst-case on-therapy | 3.1 millimeters of mercury (mmHg) | Standard Deviation 13.71 |
| Docetaxel 75 mg/m^2 in RP | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Randomized Phase | DBP, Worst-case on-therapy | 2.5 millimeters of mercury (mmHg) | Standard Deviation 7.34 |
Secondary
Duration of Response (DOR) as Assessed by the Investigator: Randomized Phase
DOR was assessed by the investigator for participants with CR (disappearance of all target and non-target lesions; any pathological lymph nodes must be \<10 mm in the short axis; without the appearance of new lesions) or PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters \[e.g., percent change from Baseline\]). DOR is defined as the time from the first documented evidence of CR or PR until the earliest date of documented radiological progression or death due to any cause. PD is defined as at least a 20% increase in the sum of the diameters (SD) of target lesions with an absolute increase of at least 5 millimeters (mm) or the appearance of at least 1 new lesion, or the worsening of non-target lesions significant enough to require study treatment discontinuation.
Time frame: Time from the first documented evidence of CR or PR until the earliest date of documented radiological progression or death due to any cause (maximum of 10.2 months)
Population: MITT Population. Only participants who achieved a CR or PR were analyzed for duration of response.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| GSK1120212 2 mg in RP | Duration of Response (DOR) as Assessed by the Investigator: Randomized Phase | 6.7 Weeks |
| Docetaxel 75 mg/m^2 in RP | Duration of Response (DOR) as Assessed by the Investigator: Randomized Phase | 12.4 Weeks |
Secondary
GSK1120212 Plasma Pharmacokinetic (PK) Concentration
Blood samples for PK analysis of GSK1120212 were collected at the following time points: Cycle 1 (Study Day 15), Cycle 2 (Study Day 22), Cycle 3 (Study Day 43), and Cycle 4 (Study Day 64). Post-dose PK samples collected on Day 15 of Cycle 1 occurred at least 1 hour apart. Participants were instructed to withhold the dose of GSK1120212 until after blood for PK samples had been drawn. Pre-dose samples were taken 15 minutes or less prior to taking the next dose (i.e., trough).
Time frame: Day 15 of Cycle 1: pre-dose; 0.5-2 hours, 2-4 hours, and 4-8 hours post-dose; Day 1 of Cycle 2, Cycle 3 and Cycle 4: pre-dose
Population: PK Population. Only participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK1120212 2 mg in RP | GSK1120212 Plasma Pharmacokinetic (PK) Concentration | Cycle 1, Day 15, pre-dose, n=80 | 16.1 Nanograms (ng)/milliliter (mL) | Standard Deviation 5.31 |
| GSK1120212 2 mg in RP | GSK1120212 Plasma Pharmacokinetic (PK) Concentration | Cycle 1, Day 15, 0.5-2 hours post-dose, n=78 | 21.5 Nanograms (ng)/milliliter (mL) | Standard Deviation 8.59 |
| GSK1120212 2 mg in RP | GSK1120212 Plasma Pharmacokinetic (PK) Concentration | Cycle 1, Day 15, 2-4 hours post-dose, n=77 | 29.7 Nanograms (ng)/milliliter (mL) | Standard Deviation 22.9 |
| GSK1120212 2 mg in RP | GSK1120212 Plasma Pharmacokinetic (PK) Concentration | Cycle 1, Day 15, 4-8 hours post-dose, n=78 | 24.8 Nanograms (ng)/milliliter (mL) | Standard Deviation 7.8 |
| GSK1120212 2 mg in RP | GSK1120212 Plasma Pharmacokinetic (PK) Concentration | Cycle 2, Day 1, pre-dose, n=75 | 16.7 Nanograms (ng)/milliliter (mL) | Standard Deviation 6.95 |
| GSK1120212 2 mg in RP | GSK1120212 Plasma Pharmacokinetic (PK) Concentration | Cycle 3, Day 1, pre-dose, n=60 | 12.9 Nanograms (ng)/milliliter (mL) | Standard Deviation 7.19 |
| GSK1120212 2 mg in RP | GSK1120212 Plasma Pharmacokinetic (PK) Concentration | Cycle 4, Day 1, pre-dose, n=38 | 13.9 Nanograms (ng)/milliliter (mL) | Standard Deviation 6.49 |
Secondary
Number of Participants With a Best Response of Either a Complete Response (CR) or Partial Response (PR) as Assessed by the Investigator: Randomized Phase
Response was assessed by the investigator according to RECIST, version 1.1, using confirmed and unconfirmed responses. Responders were defined as participants achieving either a CR (disappearance of all target and non-target lesions; any pathological lymph nodes must be \<10 millimeters \[mm\] in the short axis; without the appearance of new lesions) or PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters \[e.g., percent change from Baseline\]). Participants with unknown or missing response were treated as non-responders.
Time frame: From randomization until the first documented evidence of a CR or PR (maximum of 10.2 months)
Population: MITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK1120212 2 mg in RP | Number of Participants With a Best Response of Either a Complete Response (CR) or Partial Response (PR) as Assessed by the Investigator: Randomized Phase | CR | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With a Best Response of Either a Complete Response (CR) or Partial Response (PR) as Assessed by the Investigator: Randomized Phase | PR | 10 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With a Best Response of Either a Complete Response (CR) or Partial Response (PR) as Assessed by the Investigator: Randomized Phase | CR | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With a Best Response of Either a Complete Response (CR) or Partial Response (PR) as Assessed by the Investigator: Randomized Phase | PR | 5 Participants |
Secondary
Number of Participants With a Best Response of Either a CR or PR as Assessed by the Investigator: Crossover Phase
Response was assessed by the investigator according to RECIST, version 1.1, using confirmed and unconfirmed responses. Responders were defined as participants achieving either a CR (disappearance of all target and non-target lesions; any pathological lymph nodes must be \<10 millimeters \[mm\] in the short axis; without the appearance of new lesions) or PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters \[e.g., percent change from Baseline\]). Participants with unknown or missing response were treated as non-responders.
Time frame: From the date of the first dose of study treatment in the Crossover Phase until the first documented evidence of a CR or PR (maximum of 4 months)
Population: Crossover Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK1120212 2 mg in RP | Number of Participants With a Best Response of Either a CR or PR as Assessed by the Investigator: Crossover Phase | CR | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With a Best Response of Either a CR or PR as Assessed by the Investigator: Crossover Phase | PR | 1 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With a Best Response of Either a CR or PR as Assessed by the Investigator: Crossover Phase | CR | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With a Best Response of Either a CR or PR as Assessed by the Investigator: Crossover Phase | PR | 0 Participants |
Secondary
Number of Participants With Any SAE or Non-serious AE: Crossover Phase
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Medical or scientific judgment should have been exercised in deciding whether reporting was appropriate in other situations. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs.
Time frame: From the date of the first dose of study treatment in the Crossover Phase until 30 days following discontinuation of study treatment regardless of initiation of a new cancer therapy or transfer to hospice (maximum of 12 months)
Population: Crossover Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK1120212 2 mg in RP | Number of Participants With Any SAE or Non-serious AE: Crossover Phase | Any AE | 22 Participants |
| GSK1120212 2 mg in RP | Number of Participants With Any SAE or Non-serious AE: Crossover Phase | Any SAE | 12 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With Any SAE or Non-serious AE: Crossover Phase | Any AE | 2 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With Any SAE or Non-serious AE: Crossover Phase | Any SAE | 1 Participants |
Secondary
Number of Participants With Any Serious Adverse Event (SAE) or Non-serious Adverse Event (AE): Randomized Phase
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Medical or scientific judgment should have been exercised in deciding whether reporting was appropriate in other situations. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs.
Time frame: From randomization until 30 days following discontinuation of study treatment regardless of initiation of a new cancer therapy or transfer to hospice (maximum of 19 months)
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK1120212 2 mg in RP | Number of Participants With Any Serious Adverse Event (SAE) or Non-serious Adverse Event (AE): Randomized Phase | Any AE | 87 Participants |
| GSK1120212 2 mg in RP | Number of Participants With Any Serious Adverse Event (SAE) or Non-serious Adverse Event (AE): Randomized Phase | Any SAE | 32 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With Any Serious Adverse Event (SAE) or Non-serious Adverse Event (AE): Randomized Phase | Any AE | 43 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With Any Serious Adverse Event (SAE) or Non-serious Adverse Event (AE): Randomized Phase | Any SAE | 9 Participants |
Secondary
Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Crossover Phase
Clinical chemistry parameters were summarized according to NCI CTCAE grade, version 4.0. Grade (G) 1, Mild; Grade 2, Moderate; Grade 3 (G3), Severe; Grade 4 (G4), Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to any grade, Grade 3, or Grade 4 occurred. Clinical chemistry parameters included: albumin, alkaline phosphatase (ALKP), alanine amino transferase (ALT), aspartate amino transferase (AST), total bilirubin, calcium (hypercalcemia), calcium (hypocalcemia), creatine kinase, creatinine, glucose (hyperglycemia), glucose (hypoglycemia), potassium (hyperkalemia), potassium (hypokalemia), sodium (hypernatremia), and sodium (hyponatremia). Worst-case on-therapy changes from Baseline were summarized. Worst-case on-therapy was defined using the on-therapy window and changes were indentified using both scheduled and unscheduled assessments.
Time frame: Baseline; Days 1, 8, and 15 of Cycle 1; and Day 1 of every cycle thereafter until treatment discontinuation of the Crossover Phase (up to Study Week 19)
Population: Crossover Population: all participants who, at the point of disease progression during the Randomized Phase, elected to enter the crossover portion of the study. Only participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Crossover Phase | Albumin, Increase to any G (IAG), n=23, 1 | 15 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Crossover Phase | Albumin, Increase to G3, n=23, 1 | 4 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Crossover Phase | Albumin, Increase to G4, n=23, 1 | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Crossover Phase | ALKP, IAG, n=23, 1 | 10 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Crossover Phase | ALKP, Increase to G3, n =23, 1 | 1 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Crossover Phase | ALKP, Increase to G4, n=23, 1 | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Crossover Phase | ALT, IAG, n=23, 1 | 7 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Crossover Phase | ALT, Increase to G3, n=23, 1 | 1 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Crossover Phase | ALT, Increase to G4, n=23, 1 | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Crossover Phase | AST, IAG, n=23, 1 | 9 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Crossover Phase | AST, Increase to G3, n=23, 1 | 1 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Crossover Phase | AST, Increase to G4, n=23, 1 | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Crossover Phase | Total bilirubin, IAG, n=22, 1 | 1 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Crossover Phase | Total bilirubin, Increase to G3, n=22, 1 | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Crossover Phase | Total bilirubin, Increase to G4, n=22, 1 | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Crossover Phase | Calcium (hypercalcemia), IAG, n =23, 1 | 1 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Crossover Phase | Calcium (hypercalcemia), Increase to G3, n=23, 1 | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Crossover Phase | Calcium (hypercalcemia), Increase to G4, n=23, 1 | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Crossover Phase | Calcium (hypocalcemia), IAG, n=23, 1 | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Crossover Phase | Calcium (hypocalcemia), Increase to G3, n=23, 1 | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Crossover Phase | Calcium (hypocalcemia), Increase to G4, n=23, 1 | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Crossover Phase | Creatine kinase, IAG, n=1, 0 | 1 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Crossover Phase | Creatine kinase, Increase to G3, n=1, 0 | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Crossover Phase | Creatine kinase, Increase to G4, n=1, 0 | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Crossover Phase | Creatinine, IAG, n=23, 1 | 3 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Crossover Phase | Creatinine, Increase to G3, n=23, 1 | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Crossover Phase | Creatinine, Increase to G4, n=23, 1 | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Crossover Phase | Glucose (hyperglycemia), IAG, n=23, 1 | 10 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Crossover Phase | Glucose (hyperglycemia), Increase to G3, n=23, 1 | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Crossover Phase | Glucose (hyperglycemia), Increase to G4, n=23, 1 | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Crossover Phase | Glucose (hypoglycemia), IAG, n=23, 1 | 1 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Crossover Phase | Glucose (hypoglycemia), Increase to G3, n=23, 1 | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Crossover Phase | Glucose (hypoglycemia), Increase to G4, n=23, 1 | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Crossover Phase | Potassium (hyperkalemia), IAG, n=23, 1 | 3 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Crossover Phase | Potassium (hyperkalemia), Increase to G3, n=23, 1 | 1 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Crossover Phase | Potassium (hyperkalemia), Increase to G4, n=23, 1 | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Crossover Phase | Potassium (hypokalemia), IAG, n=23, 1 | 1 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Crossover Phase | Potassium (hypokalemia), Increase to G3, n=23, 1 | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Crossover Phase | Potassium (hypokalemia), Increase to G4, n=23, 1 | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Crossover Phase | Sodium (hypernatremia), IAG, n=23, 1 | 1 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Crossover Phase | Sodium (hypernatremia), Increase to G3, n=23, 1 | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Crossover Phase | Sodium (hypernatremia), Increase to G4, n=23, 1 | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Crossover Phase | Sodium (hyponatremia), IAG, n=23, 1 | 3 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Crossover Phase | Sodium (hyponatremia), Increase to G3, n=23, 1 | 2 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Crossover Phase | Sodium (hyponatremia), Increase to G4, n=23, 1 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Crossover Phase | Creatine kinase, Increase to G3, n=1, 0 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Crossover Phase | Albumin, Increase to any G (IAG), n=23, 1 | 1 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Crossover Phase | Sodium (hypernatremia), IAG, n=23, 1 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Crossover Phase | Albumin, Increase to G3, n=23, 1 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Crossover Phase | Creatine kinase, Increase to G4, n=1, 0 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Crossover Phase | Albumin, Increase to G4, n=23, 1 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Crossover Phase | Potassium (hyperkalemia), Increase to G3, n=23, 1 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Crossover Phase | ALKP, IAG, n=23, 1 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Crossover Phase | Creatinine, IAG, n=23, 1 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Crossover Phase | ALKP, Increase to G3, n =23, 1 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Crossover Phase | Sodium (hyponatremia), IAG, n=23, 1 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Crossover Phase | ALKP, Increase to G4, n=23, 1 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Crossover Phase | Creatinine, Increase to G3, n=23, 1 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Crossover Phase | ALT, IAG, n=23, 1 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Crossover Phase | Potassium (hyperkalemia), Increase to G4, n=23, 1 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Crossover Phase | ALT, Increase to G3, n=23, 1 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Crossover Phase | Creatinine, Increase to G4, n=23, 1 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Crossover Phase | ALT, Increase to G4, n=23, 1 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Crossover Phase | Sodium (hypernatremia), Increase to G3, n=23, 1 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Crossover Phase | AST, IAG, n=23, 1 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Crossover Phase | Glucose (hyperglycemia), IAG, n=23, 1 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Crossover Phase | AST, Increase to G3, n=23, 1 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Crossover Phase | Potassium (hypokalemia), IAG, n=23, 1 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Crossover Phase | AST, Increase to G4, n=23, 1 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Crossover Phase | Glucose (hyperglycemia), Increase to G3, n=23, 1 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Crossover Phase | Total bilirubin, IAG, n=22, 1 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Crossover Phase | Sodium (hyponatremia), Increase to G4, n=23, 1 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Crossover Phase | Total bilirubin, Increase to G3, n=22, 1 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Crossover Phase | Glucose (hyperglycemia), Increase to G4, n=23, 1 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Crossover Phase | Total bilirubin, Increase to G4, n=22, 1 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Crossover Phase | Potassium (hypokalemia), Increase to G3, n=23, 1 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Crossover Phase | Calcium (hypercalcemia), IAG, n =23, 1 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Crossover Phase | Glucose (hypoglycemia), IAG, n=23, 1 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Crossover Phase | Calcium (hypercalcemia), Increase to G3, n=23, 1 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Crossover Phase | Sodium (hypernatremia), Increase to G4, n=23, 1 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Crossover Phase | Calcium (hypercalcemia), Increase to G4, n=23, 1 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Crossover Phase | Glucose (hypoglycemia), Increase to G3, n=23, 1 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Crossover Phase | Calcium (hypocalcemia), IAG, n=23, 1 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Crossover Phase | Potassium (hypokalemia), Increase to G4, n=23, 1 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Crossover Phase | Calcium (hypocalcemia), Increase to G3, n=23, 1 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Crossover Phase | Glucose (hypoglycemia), Increase to G4, n=23, 1 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Crossover Phase | Calcium (hypocalcemia), Increase to G4, n=23, 1 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Crossover Phase | Sodium (hyponatremia), Increase to G3, n=23, 1 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Crossover Phase | Creatine kinase, IAG, n=1, 0 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Crossover Phase | Potassium (hyperkalemia), IAG, n=23, 1 | 0 Participants |
Secondary
Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase
Clinical chemistry parameters were summarized according to National Cancer Institutes (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade, version 4.0. Grade (G) 1, Mild; Grade 2, Moderate; Grade 3 (G3), Severe; Grade 4 (G4), Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to any G, G3, or G4 occurred. Clinical chemistry parameters included: albumin, alkaline phosphatase (ALKP), alanine amino transferase (ALT), aspartate amino transferase (AST), total bilirubin, calcium (hypercalcemia), calcium (hypocalcemia), creatine kinase, creatinine, glucose (hyperglycemia), glucose (hypoglycemia), potassium (hyperkalemia), potassium (hypokalemia), sodium (hypernatremia), and sodium (hyponatremia). Worst-case on-therapy changes from Baseline were summarized. Worst-case on-therapy was defined using the on-therapy window and changes were indentified using both scheduled and unscheduled assessments.
Time frame: Baseline; Days 1, 8, and 15 of Cycle 1; and Day 1 of every cycle thereafter until treatment discontinuation of the Randomized Phase (up to Study Week 40)
Population: Safety Population: all participants (KRAS, BRAF, NRAS, and MEK1 mutation positive) that received at least one dose of study treatment, based on the actual treatment received if this differed from that to which the participant was randomized. Only participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase | Albumin, Increase to any G (IAG), n=86, 43 | 57 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase | Albumin, Increase to G3, n=86, 43 | 4 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase | Albumin, Increase to G4, n=86, 43 | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase | ALKP, IAG, n=85, 43 | 26 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase | ALKP, Increase to G3, n =85, 43 | 2 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase | ALKP, Increase to G4, n=85, 43 | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase | ALT, IAG, n=87, 43 | 32 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase | ALT, Increase to G3, n=87, 43 | 3 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase | ALT, Increase to G4, n=87, 43 | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase | AST, IAG, n=86, 43 | 55 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase | AST, Increase to G3, n=86, 43 | 1 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase | AST, Increase to G4, n=86, 43 | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase | Total bilirubin, IAG, n=85, 42 | 3 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase | Total bilirubin, Increase to G3, n=85, 42 | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase | Total bilirubin, Increase to G4, n=85, 42 | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase | Calcium (hypercalcemia), IAG, n =87, 43 | 9 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase | Calcium (hypercalcemia), Increase to G3, n=87, 43 | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase | Calcium (hypercalcemia), Increase to G4, n=87, 43 | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase | Calcium (hypocalcemia), IAG, n=87, 43 | 4 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase | Calcium (hypocalcemia), Increase to G3, n=87, 43 | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase | Calcium (hypocalcemia), Increase to G4, n=87, 43 | 1 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase | Creatine kinase, IAG, n=1, 0 | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase | Creatine kinase, Increase to G3, n=1, 0 | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase | Sodium (hyponatremia), IAG, n=87, 43 | 16 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase | Creatine kinase, Increase to G4, n=1, 0 | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase | Creatinine, IAG, n=87, 43 | 12 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase | Creatinine, Increase to G3, n=87, 43 | 3 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase | Creatinine, Increase to G4, n=87, 43 | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase | Glucose (hyperglycemia), IAG, n=87, 43 | 47 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase | Glucose (hyperglycemia), Increase to G3, n=87, 43 | 5 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase | Glucose (hyperglycemia), Increase to G4, n=87, 43 | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase | Glucose (hypoglycemia), IAG, n=87, 43 | 4 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase | Glucose (hypoglycemia), Increase to G3, n=87, 43 | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase | Sodium (hyponatremia), Increase to G3, n=87, 43 | 2 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase | Sodium (hyponatremia), Increase to G4, n=87, 43 | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase | Glucose (hypoglycemia), Increase to G4, n=87, 43 | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase | Potassium (hyperkalemia), IAG, n=86, | 9 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase | Potassium (hyperkalemia), Increase to G3, n=86, 43 | 1 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase | Potassium (hyperkalemia), Increase to G4, n=86, 43 | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase | Potassium (hypokalemia), IAG, n=86, 43 | 8 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase | Potassium (hypokalemia), Increase to G3, n=86, 43 | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase | Potassium (hypokalemia), Increase to G4, n=86, 43 | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase | Sodium (hypernatremia), IAG, n=87, 43 | 12 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase | Sodium (hypernatremia), Increase to G3, n=87, 43 | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase | Sodium (hypernatremia), Increase to G4, n=87, 43 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase | Potassium (hypokalemia), IAG, n=86, 43 | 2 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase | Albumin, Increase to any G (IAG), n=86, 43 | 21 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase | Creatine kinase, Increase to G3, n=1, 0 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase | Albumin, Increase to G3, n=86, 43 | 1 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase | Sodium (hyponatremia), Increase to G4, n=87, 43 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase | Albumin, Increase to G4, n=86, 43 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase | Creatine kinase, Increase to G4, n=1, 0 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase | ALKP, IAG, n=85, 43 | 3 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase | Sodium (hypernatremia), IAG, n=87, 43 | 2 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase | ALKP, Increase to G3, n =85, 43 | 1 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase | Creatinine, IAG, n=87, 43 | 6 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase | ALKP, Increase to G4, n=85, 43 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase | Glucose (hypoglycemia), Increase to G4, n=87, 43 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase | ALT, IAG, n=87, 43 | 7 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase | Creatinine, Increase to G3, n=87, 43 | 1 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase | ALT, Increase to G3, n=87, 43 | 1 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase | Potassium (hypokalemia), Increase to G3, n=86, 43 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase | ALT, Increase to G4, n=87, 43 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase | Creatinine, Increase to G4, n=87, 43 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase | AST, IAG, n=86, 43 | 11 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase | Potassium (hyperkalemia), IAG, n=86, | 4 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase | AST, Increase to G3, n=86, 43 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase | Glucose (hyperglycemia), IAG, n=87, 43 | 24 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase | AST, Increase to G4, n=86, 43 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase | Sodium (hypernatremia), Increase to G4, n=87, 43 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase | Total bilirubin, IAG, n=85, 42 | 3 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase | Glucose (hyperglycemia), Increase to G3, n=87, 43 | 2 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase | Total bilirubin, Increase to G3, n=85, 42 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase | Potassium (hyperkalemia), Increase to G3, n=86, 43 | 1 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase | Total bilirubin, Increase to G4, n=85, 42 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase | Glucose (hyperglycemia), Increase to G4, n=87, 43 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase | Calcium (hypercalcemia), IAG, n =87, 43 | 3 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase | Potassium (hypokalemia), Increase to G4, n=86, 43 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase | Calcium (hypercalcemia), Increase to G3, n=87, 43 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase | Glucose (hypoglycemia), IAG, n=87, 43 | 4 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase | Calcium (hypercalcemia), Increase to G4, n=87, 43 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase | Potassium (hyperkalemia), Increase to G4, n=86, 43 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase | Calcium (hypocalcemia), IAG, n=87, 43 | 1 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase | Glucose (hypoglycemia), Increase to G3, n=87, 43 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase | Calcium (hypocalcemia), Increase to G3, n=87, 43 | 1 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase | Sodium (hyponatremia), IAG, n=87, 43 | 5 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase | Calcium (hypocalcemia), Increase to G4, n=87, 43 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase | Sodium (hypernatremia), Increase to G3, n=87, 43 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase | Creatine kinase, IAG, n=1, 0 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase | Sodium (hyponatremia), Increase to G3, n=87, 43 | 1 Participants |
Secondary
Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Hematology Parameters: Crossover Phase
Hematology parameters were summarized according to NCI CTCAE grade, version 4.0. Grade (G) 1, Mild; Grade 2, Moderate; Grade 3 (G3), Severe; Grade 4 (G4), Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to any G (IAG), G3, or G4 occurred. Hematology parameters included: haemoglobin (increased \[inc\]), haemoglobin (anemia), lymphocyte count (ct) (inc), lymphocyte ct (decreased \[dec\]), total absolute neutrophil count (ANC), platelet ct, and white blood cell count (WBC). Worst-case on-therapy changes from Baseline were summarized. Worst-case on-therapy was defined using the on-therapy window and changes were indentified using both scheduled and unscheduled assessments.
Time frame: Baseline; Days 1, 8, and 15 of Cycle 1; and Day 1 of every cycle thereafter until treatment discontinuation of the Crossover Phase (up to Study Week 19)
Population: Crossover Population. Only participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Hematology Parameters: Crossover Phase | Haemoglobin (inc), IAG, n=23, 1 | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Hematology Parameters: Crossover Phase | Haemoglobin (inc), Increase to G3, n=23, 1 | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Hematology Parameters: Crossover Phase | Haemoglobin (inc), Increase to G4, n=23, 1 | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Hematology Parameters: Crossover Phase | Haemoglobin (anemia), IAG, n=23, 1 | 12 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Hematology Parameters: Crossover Phase | Haemoglobin (anemia), Increase to G3, n=23, 1 | 2 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Hematology Parameters: Crossover Phase | Haemoglobin (anemia), Increase to G4, n=23, 1 | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Hematology Parameters: Crossover Phase | Lymphocyte ct (inc), IAG, n=23, 1 | 1 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Hematology Parameters: Crossover Phase | Lymphocyte ct (inc), Increase to G3, n=23, 1 | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Hematology Parameters: Crossover Phase | Lymphocyte ct (inc), Increase to G4, n=23, 1 | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Hematology Parameters: Crossover Phase | Lymphocyte ct (dec), IAG, n=23, 1 | 3 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Hematology Parameters: Crossover Phase | Lymphocyte ct (dec), Increase to G3, n=23, 1 | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Hematology Parameters: Crossover Phase | Lymphocyte ct (dec), Increase to G4, n=23, 1 | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Hematology Parameters: Crossover Phase | ANC, IAG, n=19, 0 | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Hematology Parameters: Crossover Phase | ANC, Increase to G3, n=19, 0 | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Hematology Parameters: Crossover Phase | ANC, Increase to G4, n=19, 0 | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Hematology Parameters: Crossover Phase | Platelet ct, IAG, n=23, 1 | 4 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Hematology Parameters: Crossover Phase | Platelet ct, Increase to G3, n=23, 1 | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Hematology Parameters: Crossover Phase | Platelet ct, Increase to G4, n=23, 1 | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Hematology Parameters: Crossover Phase | WBC, IAG, n=23, 1 | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Hematology Parameters: Crossover Phase | WBC, Increase to G3, n=23, 1 | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Hematology Parameters: Crossover Phase | WBC, Increase to G4, n=23, 1 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Hematology Parameters: Crossover Phase | Lymphocyte ct (dec), Increase to G3, n=23, 1 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Hematology Parameters: Crossover Phase | Haemoglobin (inc), IAG, n=23, 1 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Hematology Parameters: Crossover Phase | WBC, IAG, n=23, 1 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Hematology Parameters: Crossover Phase | Haemoglobin (inc), Increase to G3, n=23, 1 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Hematology Parameters: Crossover Phase | Lymphocyte ct (dec), Increase to G4, n=23, 1 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Hematology Parameters: Crossover Phase | Haemoglobin (inc), Increase to G4, n=23, 1 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Hematology Parameters: Crossover Phase | Platelet ct, Increase to G3, n=23, 1 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Hematology Parameters: Crossover Phase | Haemoglobin (anemia), IAG, n=23, 1 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Hematology Parameters: Crossover Phase | ANC, IAG, n=19, 0 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Hematology Parameters: Crossover Phase | Haemoglobin (anemia), Increase to G3, n=23, 1 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Hematology Parameters: Crossover Phase | WBC, Increase to G4, n=23, 1 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Hematology Parameters: Crossover Phase | Haemoglobin (anemia), Increase to G4, n=23, 1 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Hematology Parameters: Crossover Phase | ANC, Increase to G3, n=19, 0 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Hematology Parameters: Crossover Phase | Lymphocyte ct (inc), IAG, n=23, 1 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Hematology Parameters: Crossover Phase | Platelet ct, Increase to G4, n=23, 1 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Hematology Parameters: Crossover Phase | Lymphocyte ct (inc), Increase to G3, n=23, 1 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Hematology Parameters: Crossover Phase | ANC, Increase to G4, n=19, 0 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Hematology Parameters: Crossover Phase | Lymphocyte ct (inc), Increase to G4, n=23, 1 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Hematology Parameters: Crossover Phase | WBC, Increase to G3, n=23, 1 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Hematology Parameters: Crossover Phase | Lymphocyte ct (dec), IAG, n=23, 1 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Hematology Parameters: Crossover Phase | Platelet ct, IAG, n=23, 1 | 0 Participants |
Secondary
Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Hematology Parameters: Randomized Phase
Hematology parameters were summarized according to NCI CTCAE grade, version 4.0. Grade (G) 1, Mild; Grade 2, Moderate; Grade 3 (G3), Severe; Grade 4 (G4), Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to any G (IAG), G3, or G4 occurred. Hematology parameters included: haemoglobin (increased \[inc\]), haemoglobin (anemia), lymphocyte count (ct) (inc), lymphocyte ct (decreased \[dec\]), total absolute neutrophil count (ANC), platelet ct, and white blood cell count (WBC). Worst-case on-therapy changes from Baseline were summarized. Worst-case on-therapy was defined using the on-therapy window and changes were indentified using both scheduled and unscheduled assessments.
Time frame: Baseline; Days 1, 8, and 15 of Cycle 1; and Day 1 of every cycle thereafter until treatment discontinuation of the Randomized Phase (up to Study Week 40)
Population: Safety Population. Only participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Hematology Parameters: Randomized Phase | Haemoglobin (inc), IAG, n=87, 43 | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Hematology Parameters: Randomized Phase | Haemoglobin (inc), Increase to G3, n=87, 43 | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Hematology Parameters: Randomized Phase | Haemoglobin (inc), Increase to G4, n=87, 43 | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Hematology Parameters: Randomized Phase | Haemoglobin (anemia), IAG, n=86, 43 | 34 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Hematology Parameters: Randomized Phase | Haemoglobin (anemia), Increase to G3, n=86, 43 | 8 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Hematology Parameters: Randomized Phase | Haemoglobin (anemia), Increase to G4, n=86, 43 | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Hematology Parameters: Randomized Phase | Lymphocyte ct (inc), IAG, n=86, 43 | 9 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Hematology Parameters: Randomized Phase | Lymphocyte ct (inc), Increase to G3, n=86, 43 | 1 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Hematology Parameters: Randomized Phase | Lymphocyte ct (inc), Increase to G4, n=86, 43 | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Hematology Parameters: Randomized Phase | Lymphocyte ct (dec), IAG, n=85, 43 | 18 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Hematology Parameters: Randomized Phase | Lymphocyte ct (dec), Increase to G3, n=85, 43 | 4 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Hematology Parameters: Randomized Phase | Lymphocyte ct (dec), Increase to G4, n=85, 43 | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Hematology Parameters: Randomized Phase | ANC, IAG, n=86, 43 | 5 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Hematology Parameters: Randomized Phase | ANC, Increase to G3, n=86, 43 | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Hematology Parameters: Randomized Phase | ANC, Increase to G4, n=86, 43 | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Hematology Parameters: Randomized Phase | Platelet ct, IAG, n=87, 43 | 15 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Hematology Parameters: Randomized Phase | Platelet ct, Increase to G3, n=87, 43 | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Hematology Parameters: Randomized Phase | Platelet ct, Increase to G4, n=87, 43 | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Hematology Parameters: Randomized Phase | WBC, IAG, n=87, 43 | 5 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Hematology Parameters: Randomized Phase | WBC, Increase to G3, n=87, 43 | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Hematology Parameters: Randomized Phase | WBC, Increase to G4, n=87, 43 | 1 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Hematology Parameters: Randomized Phase | Lymphocyte ct (dec), Increase to G3, n=85, 43 | 2 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Hematology Parameters: Randomized Phase | Haemoglobin (inc), IAG, n=87, 43 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Hematology Parameters: Randomized Phase | WBC, IAG, n=87, 43 | 33 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Hematology Parameters: Randomized Phase | Haemoglobin (inc), Increase to G3, n=87, 43 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Hematology Parameters: Randomized Phase | Lymphocyte ct (dec), Increase to G4, n=85, 43 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Hematology Parameters: Randomized Phase | Haemoglobin (inc), Increase to G4, n=87, 43 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Hematology Parameters: Randomized Phase | Platelet ct, Increase to G3, n=87, 43 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Hematology Parameters: Randomized Phase | Haemoglobin (anemia), IAG, n=86, 43 | 27 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Hematology Parameters: Randomized Phase | ANC, IAG, n=86, 43 | 34 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Hematology Parameters: Randomized Phase | Haemoglobin (anemia), Increase to G3, n=86, 43 | 3 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Hematology Parameters: Randomized Phase | WBC, Increase to G4, n=87, 43 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Hematology Parameters: Randomized Phase | Haemoglobin (anemia), Increase to G4, n=86, 43 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Hematology Parameters: Randomized Phase | ANC, Increase to G3, n=86, 43 | 13 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Hematology Parameters: Randomized Phase | Lymphocyte ct (inc), IAG, n=86, 43 | 2 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Hematology Parameters: Randomized Phase | Platelet ct, Increase to G4, n=87, 43 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Hematology Parameters: Randomized Phase | Lymphocyte ct (inc), Increase to G3, n=86, 43 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Hematology Parameters: Randomized Phase | ANC, Increase to G4, n=86, 43 | 13 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Hematology Parameters: Randomized Phase | Lymphocyte ct (inc), Increase to G4, n=86, 43 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Hematology Parameters: Randomized Phase | WBC, Increase to G3, n=87, 43 | 17 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Hematology Parameters: Randomized Phase | Lymphocyte ct (dec), IAG, n=85, 43 | 19 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Hematology Parameters: Randomized Phase | Platelet ct, IAG, n=87, 43 | 3 Participants |
Secondary
Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Clinical Chemistry Parameters: Crossover Phase
Data are presented for only those clinical chemistry parameters for which the following worst-case on-therapy changes from Baseline with respect to the normal range were observed: decrease to low, change to normal (CTN) or no change, or increase to high. Clinical chemistry parameters included: lactate dehydrogenase, total protein, and urea/blood urea nitrogen (BUN). Worst-case on-therapy changes from Baseline were summarized. Worst-case on-therapy was defined using the on-therapy window and changes were indentified using both scheduled and unscheduled assessments. Normal ranges for each parameter may vary depending on the laboratory (central versus local) and the participant (age, gender, etc.).
Time frame: Baseline; Days 1, 8, and 15 of Cycle 1; and Day 1 of every cycle thereafter until treatment discontinuation of the Crossover Phase (up to Study Week 19)
Population: Crossover Population. Only participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Clinical Chemistry Parameters: Crossover Phase | Lactate dehydrogenase, CTN or no change | 15 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Clinical Chemistry Parameters: Crossover Phase | Total Protein, Increase to high | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Clinical Chemistry Parameters: Crossover Phase | Total Protein, Decrease to low | 15 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Clinical Chemistry Parameters: Crossover Phase | Urea/BUN, Decrease to low | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Clinical Chemistry Parameters: Crossover Phase | Lactate dehydrogenase, Increase to high | 8 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Clinical Chemistry Parameters: Crossover Phase | Urea/BUN, CTN or no change | 18 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Clinical Chemistry Parameters: Crossover Phase | Total Protein, CTN or no change | 8 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Clinical Chemistry Parameters: Crossover Phase | Urea/BUN, Increase to high | 5 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Clinical Chemistry Parameters: Crossover Phase | Lactate dehydrogenase, Decrease to low | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Clinical Chemistry Parameters: Crossover Phase | Urea/BUN, Increase to high | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Clinical Chemistry Parameters: Crossover Phase | Lactate dehydrogenase, Decrease to low | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Clinical Chemistry Parameters: Crossover Phase | Lactate dehydrogenase, CTN or no change | 1 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Clinical Chemistry Parameters: Crossover Phase | Lactate dehydrogenase, Increase to high | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Clinical Chemistry Parameters: Crossover Phase | Total Protein, Decrease to low | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Clinical Chemistry Parameters: Crossover Phase | Total Protein, CTN or no change | 1 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Clinical Chemistry Parameters: Crossover Phase | Total Protein, Increase to high | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Clinical Chemistry Parameters: Crossover Phase | Urea/BUN, Decrease to low | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Clinical Chemistry Parameters: Crossover Phase | Urea/BUN, CTN or no change | 1 Participants |
Secondary
Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Clinical Chemistry Parameters: Randomized Phase
Data are presented for only those clinical chemistry parameters for which the following worst-case on-therapy changes from Baseline with respect to the normal range were observed: decrease to low, change to normal (CTN) or no change, or increase to high. Clinical chemistry parameters included: lactate dehydrogenase, total protein, and urea/blood urea nitrogen (BUN). Worst-case on-therapy changes from Baseline were summarized. Worst-case on-therapy was defined using the on-therapy window and changes were indentified using both scheduled and unscheduled assessments. Normal ranges for each parameter may vary depending on the laboratory (central versus local) and the participant (age, gender, etc.).
Time frame: Baseline; Days 1, 8, and 15 of Cycle 1; and Day 1 of every cycle thereafter until treatment discontinuation of the Randomized Phase (up to Study Week 40)
Population: Safety Population. Only participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Clinical Chemistry Parameters: Randomized Phase | Lactate dehydrogenase, CTN or no change, n=87, 43 | 40 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Clinical Chemistry Parameters: Randomized Phase | Total Protein, Increase to high, n=86, 43 | 1 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Clinical Chemistry Parameters: Randomized Phase | Total Protein, Decrease to low, n=86, 43 | 31 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Clinical Chemistry Parameters: Randomized Phase | Urea/BUN, Decrease to low, n=87, 43 | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Clinical Chemistry Parameters: Randomized Phase | Lactate dehydrogenase, Increase to high, n=87, 43 | 46 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Clinical Chemistry Parameters: Randomized Phase | Urea/BUN, CTN or no change, n=87, 43 | 62 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Clinical Chemistry Parameters: Randomized Phase | Total Protein, CTN or no change, n=86, 43 | 55 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Clinical Chemistry Parameters: Randomized Phase | Urea/BUN, Increase to high, n=87,43 | 25 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Clinical Chemistry Parameters: Randomized Phase | Lactate dehydrogenase, Decrease to low, n=87, 43 | 1 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Clinical Chemistry Parameters: Randomized Phase | Urea/BUN, Increase to high, n=87,43 | 9 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Clinical Chemistry Parameters: Randomized Phase | Lactate dehydrogenase, Decrease to low, n=87, 43 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Clinical Chemistry Parameters: Randomized Phase | Lactate dehydrogenase, CTN or no change, n=87, 43 | 23 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Clinical Chemistry Parameters: Randomized Phase | Lactate dehydrogenase, Increase to high, n=87, 43 | 20 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Clinical Chemistry Parameters: Randomized Phase | Total Protein, Decrease to low, n=86, 43 | 12 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Clinical Chemistry Parameters: Randomized Phase | Total Protein, CTN or no change, n=86, 43 | 31 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Clinical Chemistry Parameters: Randomized Phase | Total Protein, Increase to high, n=86, 43 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Clinical Chemistry Parameters: Randomized Phase | Urea/BUN, Decrease to low, n=87, 43 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Clinical Chemistry Parameters: Randomized Phase | Urea/BUN, CTN or no change, n=87, 43 | 34 Participants |
Secondary
Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Crossover Phase
Data are presented for only those hematology parameters for which the following worst-case on-therapy changes from Baseline with respect to the normal range were observed: decrease to low, change to normal (CTN) or no change, or increase to high. Hematology parameters included: atypical lymphs, atypical lymphs (percentage \[%\]), basophils, eosinophils, metamyelocytes, monocytes, and myelocytes. Worst-case on-therapy changes from Baseline were summarized. Worst-case on-therapy was defined using the on-therapy window and changes were indentified using both scheduled and unscheduled assessments. Normal ranges for each parameter may vary depending on the laboratory (central versus local) and the participant (age, gender, etc.).
Time frame: Baseline; Days 1, 8, and 15 of Cycle 1; and Day 1 of every cycle thereafter until treatment discontinuation of the Crossover Phase (up to Study Week 19)
Population: Crossover Population. Only participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Crossover Phase | Atypical lymphs, Decrease to low, n=3, 1 | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Crossover Phase | Atypical lymphs, CTN or no change, n=3, 1 | 1 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Crossover Phase | Atypical lymphs, Increase to high, n=3, 1 | 2 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Crossover Phase | Atypical lymphs (%), Decrease to low, n=3, 1 | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Crossover Phase | Atypical lymphs (%), CTN or no change, n=3, 1 | 1 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Crossover Phase | Atypical lymphs (%), Increase to high, n=3, 1 | 2 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Crossover Phase | Basophils, Decrease to low, n=23, 1 | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Crossover Phase | Basophils, CTN or no change, n=23, 1 | 23 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Crossover Phase | Basophils, Increase to high, n=23, 1 | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Crossover Phase | Eosinophils, Decrease to low, n=23, 1 | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Crossover Phase | Eosinophils, CTN or no change, n=23, 1 | 23 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Crossover Phase | Eosinophils, Increase to high, n=23, 1 | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Crossover Phase | Metamyelocytes, Decrease to low, n=1, 1 | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Crossover Phase | Metamyelocytes, CTN or no change, n=1, 1 | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Crossover Phase | Metamyelocytes, Increase to high, n=1, 1 | 1 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Crossover Phase | Monocytes, Decrease to low, n=23, 1 | 1 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Crossover Phase | Monocytes, CTN or no change, n=23, 1 | 20 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Crossover Phase | Monocytes, Increase to high, n=23, 1 | 2 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Crossover Phase | Myelocytes, Decrease to low, n=3, 1 | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Crossover Phase | Myelocytes, CTN or no change, n=3, 1 | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Crossover Phase | Myelocytes, Increase to high, n=3, 1 | 3 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Crossover Phase | Eosinophils, CTN or no change, n=23, 1 | 1 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Crossover Phase | Atypical lymphs, Decrease to low, n=3, 1 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Crossover Phase | Myelocytes, Decrease to low, n=3, 1 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Crossover Phase | Atypical lymphs, CTN or no change, n=3, 1 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Crossover Phase | Eosinophils, Increase to high, n=23, 1 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Crossover Phase | Atypical lymphs, Increase to high, n=3, 1 | 1 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Crossover Phase | Monocytes, CTN or no change, n=23, 1 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Crossover Phase | Atypical lymphs (%), Decrease to low, n=3, 1 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Crossover Phase | Metamyelocytes, Decrease to low, n=1, 1 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Crossover Phase | Atypical lymphs (%), CTN or no change, n=3, 1 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Crossover Phase | Myelocytes, Increase to high, n=3, 1 | 1 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Crossover Phase | Atypical lymphs (%), Increase to high, n=3, 1 | 1 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Crossover Phase | Metamyelocytes, CTN or no change, n=1, 1 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Crossover Phase | Basophils, Decrease to low, n=23, 1 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Crossover Phase | Monocytes, Increase to high, n=23, 1 | 1 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Crossover Phase | Basophils, CTN or no change, n=23, 1 | 1 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Crossover Phase | Metamyelocytes, Increase to high, n=1, 1 | 1 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Crossover Phase | Basophils, Increase to high, n=23, 1 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Crossover Phase | Myelocytes, CTN or no change, n=3, 1 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Crossover Phase | Eosinophils, Decrease to low, n=23, 1 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Crossover Phase | Monocytes, Decrease to low, n=23, 1 | 0 Participants |
Secondary
Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Randomized Phase
Data are presented for only those hematology parameters for which the following worst-case on-therapy changes from Baseline with respect to the normal range were observed: decrease to low, change to normal (CTN) or no change, or increase to high. Hematology parameters included: atypical lymphs, atypical lymphs (percentage \[%\]), basophils, eosinophils, metamyelocytes, monocytes, myelocytes, neutrophil bands (%). Worst-case on-therapy changes from Baseline were summarized. Worst-case on-therapy was defined using the on-therapy window and changes were indentified using both scheduled and unscheduled assessments. Normal ranges for each parameter may vary depending on the laboratory (central versus local) and the participant (age, gender, etc.).
Time frame: Baseline; Days 1, 8, and 15 of Cycle 1; and Day 1 of every cycle thereafter until treatment discontinuation of the Randomized Phase (up to Study Week 40)
Population: Safety Population. Only participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Randomized Phase | Atypical lymphs, Decrease to low, n=0, 3 | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Randomized Phase | Eosinophils, Increase to high, n=86, 43 | 9 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Randomized Phase | Atypical lymphs (%), Increase to high, n=0, 3 | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Randomized Phase | Metamyelocytes, Decrease to low, n=1, 7 | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Randomized Phase | Atypical lymphs, Increase to high, n=0, 3 | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Randomized Phase | Metamyelocytes, CTN or no change, n=1, 7 | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Randomized Phase | Basophils, Decrease to low, n=86, 43 | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Randomized Phase | Metamyelocytes, Increase to high, n=1, 7 | 1 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Randomized Phase | Myelocytes, Increase to high, n=1, 9 | 1 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Randomized Phase | Monocytes, Decrease to low, n=86, 43 | 3 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Randomized Phase | Basophils, CTN or no change, n=86, 43 | 82 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Randomized Phase | Monocytes, CTN or no change, n=86, 43 | 78 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Randomized Phase | Atypical lymphs (%), Decrease to low, n =0, 3 | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Randomized Phase | Monocytes, Increase to high, n=86, 43 | 5 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Randomized Phase | Basophils, Increase to high, n=86,43 | 4 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Randomized Phase | Myelocytes, Decrease to low, n=1, 9 | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Randomized Phase | Atypical lymphs, CTN or no change, n=0, 3 | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Randomized Phase | Eosinophils, Decrease to low, n=86, 43 | 1 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Randomized Phase | Neutrophil Bands (%), Decrease to low, n=1, 4 | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Randomized Phase | Atypical lymphs (%), CTN or no change, n=0, 3 | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Randomized Phase | Neutrophil Bands (%), CTN or no change, n=1, 4 | 1 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Randomized Phase | Eosinophils, CTN or no change, n=86, 43 | 77 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Randomized Phase | Neutrophil Bands (%), Increase to high, n=1, 4 | 0 Participants |
| GSK1120212 2 mg in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Randomized Phase | Myelocytes, CTN or no change, n=1, 9 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Randomized Phase | Neutrophil Bands (%), Increase to high, n=1, 4 | 1 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Randomized Phase | Myelocytes, CTN or no change, n=1, 9 | 1 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Randomized Phase | Atypical lymphs, Decrease to low, n=0, 3 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Randomized Phase | Atypical lymphs, CTN or no change, n=0, 3 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Randomized Phase | Atypical lymphs, Increase to high, n=0, 3 | 3 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Randomized Phase | Atypical lymphs (%), Decrease to low, n =0, 3 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Randomized Phase | Atypical lymphs (%), CTN or no change, n=0, 3 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Randomized Phase | Atypical lymphs (%), Increase to high, n=0, 3 | 3 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Randomized Phase | Basophils, Decrease to low, n=86, 43 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Randomized Phase | Basophils, CTN or no change, n=86, 43 | 41 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Randomized Phase | Basophils, Increase to high, n=86,43 | 2 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Randomized Phase | Eosinophils, Decrease to low, n=86, 43 | 1 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Randomized Phase | Eosinophils, CTN or no change, n=86, 43 | 42 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Randomized Phase | Eosinophils, Increase to high, n=86, 43 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Randomized Phase | Metamyelocytes, Decrease to low, n=1, 7 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Randomized Phase | Metamyelocytes, CTN or no change, n=1, 7 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Randomized Phase | Metamyelocytes, Increase to high, n=1, 7 | 7 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Randomized Phase | Monocytes, Decrease to low, n=86, 43 | 20 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Randomized Phase | Monocytes, CTN or no change, n=86, 43 | 18 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Randomized Phase | Monocytes, Increase to high, n=86, 43 | 9 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Randomized Phase | Myelocytes, Decrease to low, n=1, 9 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Randomized Phase | Myelocytes, Increase to high, n=1, 9 | 8 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Randomized Phase | Neutrophil Bands (%), Decrease to low, n=1, 4 | 0 Participants |
| Docetaxel 75 mg/m^2 in RP | Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Randomized Phase | Neutrophil Bands (%), CTN or no change, n=1, 4 | 3 Participants |
Secondary
Overall Survival (OS)
OS is defined as the interval of time between the date of randomization and the date of death due to any cause. For participants who did not die, OS was censored at the date of last contact.
Time frame: Time interval between the date of randomization and the date of death due to any cause (maximum of 22 months)
Population: MITT Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| GSK1120212 2 mg in RP | Overall Survival (OS) | 8.1 Months |
| Docetaxel 75 mg/m^2 in RP | Overall Survival (OS) | 9.9 Months |