Metastatic Cervical Cancer, Neoplasms, Uterine Cervix
Conditions
Keywords
pazopanib, ErB1/ErB2, lapatinib, persistent, VEGF, recurrent, metastatic cervical cancer, advanced, FIGO Stage IVB
Brief summary
This study is being conducted to compare the efficacy and safety of pazopanib in combination with lapatinib with that of lapatinib alone or pazopanib alone in subjects with metastatic cervical cancer
Detailed description
A Phase II, Open-Label, Randomized, Multicenter Trial of Pazopanib (GW786034) in Combination with Lapatinib (GW572016) Compared to Pazopanib Monotherapy and Lapatinib Monotherapy in Subjects with International Federation of Gynecology (FIGO) Stage IVB or Recurrent or Persistent Cervical Cancer with Zero or One Prior Chemotherapy Regimen for Advanced/Recurrent Disease
Interventions
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* A subject will be eligible for inclusion in this study only if all of the following criteria are met: * Signed, written informed consent prior to performing any study-related procedures * Female subjects ≥18 years of age * FIGO Stage IVB, or recurrent or persistent cervical cancer * Life expectancy of at least 12 weeks * ECOG status of 0 or 1. * Histologically confirmed FIGO Stage IVB, or recurrent or persistent squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix which is not amenable to curative treatment with surgery and/or radiation therapy * Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded). Each lesion must be ≥ 20 mm when measured by conventional techniques, including palpitation, plain x-ray, CT and MRI, or ≥10 mm when measured by spiral CT. * At least one target lesion to be used to assess response as defined by Response Evaluation Criteria in Solid Tumors (RECIST; Terasse, 2000). Tumors within a previously irradiated field will be designated as non-target lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy. * Received 0 or 1 prior chemotherapy regimen for metastatic disease. * Note: Chemotherapy given in combination with radiation therapy as a radiosensitizer does not count toward this prior therapy limit * Recovered from the effects of surgery or chemotherapy. At least three weeks must have elapsed from the last administration of chemotherapy. * Adequate organ and bone marrow function as defined in Table 1. * Table 1:(Definitions for Adequate Organ Function) * System:(Laboratory Values) * Hematologic: Absolute neutrophil count (ANC)(≥ 1.5 X 109/L)Hemoglobin1(≥9 g/dL)Platelets(≥100 X 109/L) * Hepatic: Total bilirubin (≤1.5 X ULN)AST and ALT (≤2.5 X ULN) * Renal: Calculated creatinine clearance2 (≥50 mL/min) * Urine protein3 (Negative, trace or +1 by dipstick urinalysis or \<1.0 gram determined by 24 hour urine protein analysis.) * Subjects may not have had a transfusion within 7 days of screening assessment. * Calculated by Cockcroft Gault formula See Appendix 7: Renal Function Tests * A patient should first be screened with dipstick urinalysis. If urine protein by dipstick analysis is ≥2+, then a 24-hour urine protein must be assessed and 24 hour urine protein must be \<1 g protein to be eligible. * Ability to swallow and retain oral medication. * A female is eligible to enter and participate in this study if she is of: * Non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who has had: * A hysterectomy * A bilateral oophorectomy (ovariectomy) * A bilateral tubal ligation * Is post-menopausal (total cessation of menses for ≥ 1 year) * Childbearing potential, has a negative serum pregnancy test within 2 weeks prior to the first dose of study treatment, preferably as close to the first dose as possible, and agrees to use adequate contraception. GSK acceptable contraceptive methods, when used consistently and in accordance with both the product label and the instructions of the physician, are as follows: * An intrauterine device with a documented failure rate of less than 1% per year. * Vasectomized partner who is sterile prior to the female subject's entry and is the sole sexual partner for that female. * Complete abstinence from sexual intercourse for 14 days before exposure to investigation product, through the dosing period, and for at least 21 days after the last dose of investigational product. * Double-barrier contraception (condom with spermicidal jelly, foam suppository, or film; diaphragm with spermicide; or male condom and diaphragm with spermicide). Note: Oral contraceptives are not reliable due to potential drug-drug interactions. * Subjects must provide written informed consent prior to performance of study specific procedures or assessments, and must be willing to comply with treatment and follow-up as outlined in the protocol. Procedures conducted as apart of routine clinical management of the patient (e.g., blood count, imaging study) and obtained prior to signed informed consent may be utilized for screening purposes provided these tests are obtained as specified in the protocol
Exclusion criteria
* A subject will not be eligible for inclusion in this study if any of the following criteria apply: * Neuroendocrine or small cell carcinoma of the cervix. * Prior use of any biologic therapy with VEGF, VEGFR, or ErbB1/ErbB2 inhibitors. * Concurrent cancer therapy (chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, hormonal therapy, and tumor embolization). * Concurrent treatment with an investigational agent or participation in another clinical trial. * Use of an investigational anti-cancer drug within 28 days or 5 half-lives, whichever is longer, preceding the first dose of study medication. * Has taken or is taking prohibited medications listed in the protocol. * Any serious and/or unstable pre-existing medical, psychiatric, or other conditions that could interfere with patient's safety, obtaining informed consent or compliance to the study. * History of another malignancy. Note: Patients who have had another malignancy and have been disease-free for 5 years, or patients with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma are eligible. * History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis. Routine screening with CNS imaging studies (computed tomography \[CT\] or magnetic resonance imaging \[MRI\]) is required only if clinically indicated. * Malabsorption Syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel. * Active peptic ulcer disease, inflammatory bowel disease, or other gastrointestinal condition increasing the risk of perforation; history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 4 weeks prior to beginning therapy. * Presence of uncontrolled infection. * Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib. * Corrected QT interval (QTc) prolongation defined as QTc interval \> 470 msecs. * History of any one of the following cardiac conditions within the past 6 months: * Cardiac angioplasty or stenting * Myocardial infarction * Unstable angina * History of cerebrovascular accident or pulmonary embolus within the past 6 months. * Has Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system (See Appendix 6) * Poorly controlled hypertension (systolic blood pressure (SBP) of ≥ 140mmHg, or diastolic blood pressure (DBP) of ≥ 90mmHg). * Note: Initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry. The blood pressure (BP) must be re-assessed on two occasions that are separated by a minimum of 24 hours. The mean SBP/DBP values from both BP assessments must be \< 140/90mmHg in order for a subject to be eligible for the study. * History of untreated deep venous thrombosis (DVT) within the past 6 months (e.g. calf vein thrombosis). * Note: Patients with recent DVT who are treated with therapeutic anti-coagulant agents (excluding therapeutic warfarin) for at least 6 weeks are eligible. * Presence of any non-healing, non-tumor related wound, fracture, or ulcer, or the presence of symptomatic peripheral vascular disease. * Subjects with bilateral hydronephrosis which cannot be alleviated by ureteral stents or percutaneous drainage. * Major surgical procedure, open biopsy, or significant traumatic injury within 4 weeks prior to beginning therapy, or anticipation of the need for a major surgical procedure during the course of the study; minor surgical procedures such as fine needle aspiration or core biopsy within 1 week prior to beginning therapy are also excluded. * Unable to swallow and retain orally administered medication. * Pregnant or lactating female.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival (PFS) in Interim Analysis | From randomization until at least 35 PFS events in pairwise comparison of the three treatment arms (Interim Analysis; up to 52.14 weeks) | PFS is defined as the interval between the date of randomization and the date of disease progression or death due to any cause. The study was designed to test Combination vs. Lapatinib first. The result indicated that Combination would not show improvement over Lapatinib even if followed until the final analysis and the Combination arm was terminated. The monotherapy arms continued to the final analysis. Data shown here are from this interim analysis. |
| Progression-free Survival (PFS) in Final Analysis | From Randomization until 105 total PFS events in combined population of two monotherapy arms (up to 85.57 weeks) | PFS is defined as the interval between the date of randomization and the date of disease progression or death due to any cause. This study began as a 3-arm study. The combination arm was terminated at the interim analysis. The monotherapy arms continued to final analysis. Data shown here are from the final analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Response | From Randomization until 105 total PFS events in combined population of two monotherapy arms (up to 85.57 weeks) | Response is defined as the number of participants achieving either a complete or partial tumor response per RECIST criteria. CR, all detectable tumor has disappeared; PR, a \>=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum. |
| Time to Response | From Randomization until 105 total PFS events in combined population of two monotherapy arms (up to 85.57 weeks) | For the subset of participants who showed a confirmed CR or PR, time to response was defined as the time from randomization until the first documented evidence of CR or PR (whichever status was recorded first). CR, all detectable tumor has disappeared; PR, a \>=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum. |
| Overall Survival | From Randomization (11 December 2006) until approximately 78% overall survival events at the time of the second overall survival update (3 March 2010) (up to 168.29 weeks) | Overall survival is defined as the time from randomization until death due to any cause. |
| Safety and Tolerability of Pazopanib, Lapatinib and the Combination of Pazopanib and Lapatinib | From Randomization (11 December 2006) until last participant had last visit (28 July 2011) in combined population of two monotherapy arms (up to 241.43 weeks) | Safety was assessed as the number of participants experiencing a serious adverse event (SAE) or an adverse event (AE). See the adverse event module for safety data. |
| Duration of Response | From Randomization until 105 total PFS events in combined population of two monotherapy arms (up to 85.57 weeks) | For participants who had a CR or PR, the duration of response was defined as the time from first documented evidence of PR or CR until the first documented sign of disease progression or death. CR, all detectable tumor has disappeared; PR, a \>=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum. |
| Clinical Benefit Response | From Randomization until 105 total PFS events in combined population of two monotherapy arms (up to 85.57 weeks) | Clinical benefit response is defined as the number of participants with evidence of complete (CR) or partial (PR) tumor response or stable disease (SD) for at least 6 months (183 days). Per Response Evaluation Criteria In Solid Tumors (RECIST): CR, all detectable tumor has disappeared; PR, a \>=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum; Stable Disease, small changes that do not meet previously given criteria. Confirmation requires at least 2 assessments of CR/PR with at least 4 weeks between assessments. |
Countries
Argentina, Belgium, Canada, Estonia, France, Germany, India, Ireland, Italy, Mexico, Spain, Thailand, United States
Participant flow
Recruitment details
Participants (par.) continued to be enrolled into all three treatment arms after clinical data cutoff for the interim analysis, but before the results were evaluated. Final total enrollment was 228 participants: 76 in the combination arm, 78 in the lapatinib monotherapy arm, and 74 in the pazopanib monotherapy arm.
Pre-assignment details
Study was initially designed and started as a randomized, three-arm, controlled trial. Participants were randomized to the combination of pazopanib plus lapatinib, pazopanib monotherapy, or lapatinib monotherapy. Based on results from a planned interim analysis, the combination group was terminated, but the monotherapy groups continued as planned.
Participants by arm
| Arm | Count |
|---|---|
| Combination Therapy: Lapatinib 1500 mg and Pazopanib 800 mg Lapatinib 1500 mg (6 x 250 mg tablets) and pazopanib 800 mg (2 x 400 mg tablets) daily | 59 |
| Lapatinib Monotherapy 1500 mg (6 x 250 mg tablets) of oral lapatinib daily | 58 |
| Pazopanib Monotherapy 800 mg (2 x 400 mg tablets) of oral pazopanib daily | 60 |
| Total | 177 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| End-of-Study Analysis; 28 July 2011 | Lost to Follow-up | 5 | 3 | 3 |
| End-of-Study Analysis; 28 July 2011 | Other | 4 | 1 | 0 |
| End-of-Study Analysis; 28 July 2011 | Physician Decision | 4 | 6 | 6 |
| End-of-Study Analysis; 28 July 2011 | Protocol Violation | 0 | 1 | 0 |
| End-of-Study Analysis; 28 July 2011 | Sponsor Terminated Study | 4 | 5 | 4 |
| End-of-Study Analysis; 28 July 2011 | Withdrawal by Subject | 7 | 2 | 7 |
| Final Analysis; 31 July 2008 | Lost to Follow-up | 0 | 0 | 3 |
| Final Analysis; 31 July 2008 | Ongoing | 0 | 29 | 32 |
| Final Analysis; 31 July 2008 | Other | 0 | 1 | 0 |
| Final Analysis; 31 July 2008 | Physician Decision | 0 | 6 | 6 |
| Final Analysis; 31 July 2008 | Protocol Violation | 0 | 1 | 0 |
| Final Analysis; 31 July 2008 | Withdrawal by Subject | 0 | 2 | 7 |
| Interim Analysis; 11 February 2008 | Adverse Event | 10 | 3 | 7 |
| Interim Analysis; 11 February 2008 | Death | 0 | 1 | 0 |
| Interim Analysis; 11 February 2008 | Disease Progression | 16 | 30 | 22 |
| Interim Analysis; 11 February 2008 | Lost to Follow-up | 1 | 0 | 1 |
| Interim Analysis; 11 February 2008 | Ongoing | 23 | 20 | 25 |
| Interim Analysis; 11 February 2008 | Par. Withdrew; Followed for Survival | 2 | 0 | 0 |
| Interim Analysis; 11 February 2008 | Physician Decision | 2 | 3 | 3 |
| Interim Analysis; 11 February 2008 | Protocol Violation | 0 | 1 | 0 |
| Interim Analysis; 11 February 2008 | Sponsor Terminated Study | 1 | 0 | 0 |
| Interim Analysis; 11 February 2008 | Withdrawal by Subject | 4 | 0 | 2 |
Baseline characteristics
| Characteristic | Total | Pazopanib Monotherapy | Lapatinib Monotherapy | Combination Therapy: Lapatinib 1500 mg and Pazopanib 800 mg |
|---|---|---|---|---|
| Age, Continuous | 50 years STANDARD_DEVIATION 11.1 | 50.8 years STANDARD_DEVIATION 10.93 | 49.2 years STANDARD_DEVIATION 11.27 | NA years |
| Gender Female | 152 participants | 74 participants | 78 participants | NA participants |
| Gender Male | 0 participants | 0 participants | 0 participants | NA participants |
| Histology at diagnosis: Final Anaysis Adenocarcinoma | 23 participants | 12 participants | 11 participants | NA participants |
| Histology at diagnosis: Final Anaysis Adenosquamous carcinoma | 7 participants | 3 participants | 4 participants | NA participants |
| Histology at diagnosis: Final Anaysis Other | 14 participants | 6 participants | 8 participants | NA participants |
| Histology at diagnosis: Final Anaysis Squamous cell carcinoma | 108 participants | 53 participants | 55 participants | NA participants |
| Histology at diagnosis: Interim Analysis Adenocarcinoma | 31 participants | 8 participants | 8 participants | 15 participants |
| Histology at diagnosis: Interim Analysis Adenosquamous carcinoma | 7 participants | 3 participants | 4 participants | 0 participants |
| Histology at diagnosis: Interim Analysis Missing | 3 participants | 1 participants | 0 participants | 2 participants |
| Histology at diagnosis: Interim Analysis Other | 23 participants | 5 participants | 8 participants | 10 participants |
| Histology at diagnosis: Interim Analysis Squamous cell carcinoma | 113 participants | 43 participants | 38 participants | 32 participants |
| Race/Ethnicity, Customized African American | 1 participants | 0 participants | 1 participants | NA participants |
| Race/Ethnicity, Customized American Indian | 26 participants | 12 participants | 4 participants | 10 participants |
| Race/Ethnicity, Customized Asian-Central , South | 2 participants | 0 participants | 2 participants | NA participants |
| Race/Ethnicity, Customized Asian-South East | 30 participants | 9 participants | 13 participants | 12 participants |
| Race/Ethnicity, Customized White | 120 participants | 40 participants | 43 participants | 37 participants |
| Sex: Female, Male Female | 177 Participants | 60 Participants | 58 Participants | 59 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 71 / 76 | 66 / 76 | 69 / 74 |
| serious Total, serious adverse events | 32 / 76 | 22 / 76 | 28 / 74 |
Outcome results
Primary
Progression-free Survival (PFS) in Final Analysis
PFS is defined as the interval between the date of randomization and the date of disease progression or death due to any cause. This study began as a 3-arm study. The combination arm was terminated at the interim analysis. The monotherapy arms continued to final analysis. Data shown here are from the final analysis.
Time frame: From Randomization until 105 total PFS events in combined population of two monotherapy arms (up to 85.57 weeks)
Population: ITT Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Combination Therapy: Lapatinib 1500 mg and Pazopanib 800 mg | Progression-free Survival (PFS) in Final Analysis | 17.1 Weeks |
| Lapatinib Monotherapy | Progression-free Survival (PFS) in Final Analysis | 18.1 Weeks |
p-value: 0.01390% CI: [0.48, 0.91]Log Rank
Primary
Progression-free Survival (PFS) in Interim Analysis
PFS is defined as the interval between the date of randomization and the date of disease progression or death due to any cause. The study was designed to test Combination vs. Lapatinib first. The result indicated that Combination would not show improvement over Lapatinib even if followed until the final analysis and the Combination arm was terminated. The monotherapy arms continued to the final analysis. Data shown here are from this interim analysis.
Time frame: From randomization until at least 35 PFS events in pairwise comparison of the three treatment arms (Interim Analysis; up to 52.14 weeks)
Population: Intent to Treat (ITT) Population: all randomized participants
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Combination Therapy: Lapatinib 1500 mg and Pazopanib 800 mg | Progression-free Survival (PFS) in Interim Analysis | 12.6 Weeks |
| Lapatinib Monotherapy | Progression-free Survival (PFS) in Interim Analysis | 12.6 Weeks |
| Pazopanib Monotherapy | Progression-free Survival (PFS) in Interim Analysis | 17.9 Weeks |
p-value: 0.53590% CI: [0.65, 1.7]Log Rank
Secondary
Clinical Benefit Response
Clinical benefit response is defined as the number of participants with evidence of complete (CR) or partial (PR) tumor response or stable disease (SD) for at least 6 months (183 days). Per Response Evaluation Criteria In Solid Tumors (RECIST): CR, all detectable tumor has disappeared; PR, a \>=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum; Stable Disease, small changes that do not meet previously given criteria. Confirmation requires at least 2 assessments of CR/PR with at least 4 weeks between assessments.
Time frame: From Randomization until 105 total PFS events in combined population of two monotherapy arms (up to 85.57 weeks)
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Combination Therapy: Lapatinib 1500 mg and Pazopanib 800 mg | Clinical Benefit Response | 7 participants |
| Lapatinib Monotherapy | Clinical Benefit Response | 15 participants |
Secondary
Duration of Response
For participants who had a CR or PR, the duration of response was defined as the time from first documented evidence of PR or CR until the first documented sign of disease progression or death. CR, all detectable tumor has disappeared; PR, a \>=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum.
Time frame: From Randomization until 105 total PFS events in combined population of two monotherapy arms (up to 85.57 weeks)
Population: ITT Population. The median for lapatinib was not reached at the time of data cut-off. No formal analysis of this endpoint was conducted for this group due to a very small number of responding participants.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Lapatinib Monotherapy | Duration of Response | 48.1 weeks |
Secondary
Overall Survival
Overall survival is defined as the time from randomization until death due to any cause.
Time frame: From Randomization (11 December 2006) until approximately 78% overall survival events at the time of the second overall survival update (3 March 2010) (up to 168.29 weeks)
Population: ITT Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Combination Therapy: Lapatinib 1500 mg and Pazopanib 800 mg | Overall Survival | 44.1 Weeks |
| Lapatinib Monotherapy | Overall Survival | 49.7 Weeks |
Secondary
Response
Response is defined as the number of participants achieving either a complete or partial tumor response per RECIST criteria. CR, all detectable tumor has disappeared; PR, a \>=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum.
Time frame: From Randomization until 105 total PFS events in combined population of two monotherapy arms (up to 85.57 weeks)
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Combination Therapy: Lapatinib 1500 mg and Pazopanib 800 mg | Response | 4 participants |
| Lapatinib Monotherapy | Response | 7 participants |
p-value: 0.237Fisher Exact
Secondary
Safety and Tolerability of Pazopanib, Lapatinib and the Combination of Pazopanib and Lapatinib
Safety was assessed as the number of participants experiencing a serious adverse event (SAE) or an adverse event (AE). See the adverse event module for safety data.
Time frame: From Randomization (11 December 2006) until last participant had last visit (28 July 2011) in combined population of two monotherapy arms (up to 241.43 weeks)
Population: Safety Population: all participants who received at least one dose of study drug
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Combination Therapy: Lapatinib 1500 mg and Pazopanib 800 mg | Safety and Tolerability of Pazopanib, Lapatinib and the Combination of Pazopanib and Lapatinib | Serious adverse events | 22 participants |
| Combination Therapy: Lapatinib 1500 mg and Pazopanib 800 mg | Safety and Tolerability of Pazopanib, Lapatinib and the Combination of Pazopanib and Lapatinib | Other adverse events with >5% occurrence | 66 participants |
| Lapatinib Monotherapy | Safety and Tolerability of Pazopanib, Lapatinib and the Combination of Pazopanib and Lapatinib | Serious adverse events | 28 participants |
| Lapatinib Monotherapy | Safety and Tolerability of Pazopanib, Lapatinib and the Combination of Pazopanib and Lapatinib | Other adverse events with >5% occurrence | 69 participants |
| Pazopanib Monotherapy | Safety and Tolerability of Pazopanib, Lapatinib and the Combination of Pazopanib and Lapatinib | Serious adverse events | 32 participants |
| Pazopanib Monotherapy | Safety and Tolerability of Pazopanib, Lapatinib and the Combination of Pazopanib and Lapatinib | Other adverse events with >5% occurrence | 71 participants |
Secondary
Time to Response
For the subset of participants who showed a confirmed CR or PR, time to response was defined as the time from randomization until the first documented evidence of CR or PR (whichever status was recorded first). CR, all detectable tumor has disappeared; PR, a \>=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum.
Time frame: From Randomization until 105 total PFS events in combined population of two monotherapy arms (up to 85.57 weeks)
Population: ITT Population
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Combination Therapy: Lapatinib 1500 mg and Pazopanib 800 mg | Time to Response | 18.2 weeks |
| Lapatinib Monotherapy | Time to Response | 6.9 weeks |