Non Small Cell Lung Cancer
Conditions
Brief summary
Patients affected by non-small cell lung cancer (NSCLC) will be treated in pemetrexed monochemotherapy regimen for a maximum of 8 cycles. Pemetrexed is an enhancer of some biomolecules involved in the gemcitabine mechanism of action. Purpose of the trial is to monitor the blood values of these biomolecules at different time intervals, to optimize the synergism between pemetrexed and gemcitabine.
Interventions
DRUGPemetrexed - Before Protocol Amendment
500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles or disease progression, unacceptable toxicity or patient decision to discontinue
DRUGPemetrexed - After Protocol Amendment
500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days x 6 cycles or disease progression, unacceptable toxicity or patient decision to discontinue.
Sponsors
Eli Lilly and Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically or cytologically proven IIIB and IV NSCLC. * No symptomatic uncontrolled brain metastasis * Not suitable for platinum containing regimens if chemo-naive * Performance status less than or equal to 2 on the Eastern Cooperative Oncology Group (ECOG) Scale. * Creatinine Clearance (CrCl) greater than or equal to 45 milliliters per min (mL/min)
Exclusion criteria
* Prior radiation to greater than 25% of bone marrow * Inability to interrupt Aspirin at doses of greater than 1.3 grams/day or non-steroidal anti-inflammatory agents for a 5-day period. * Presence of clinically relevant third-space fluid collections not controllable. * Significant cardiac disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Deoxycytidine Kinase (dCK) Expression Evaluated at Cycle 1, Cycle 2, and Cycle 3 | pre-dose, 1, 2, 4, 6, 24, and 48 hours post-dose (3 cycles) | dCK and hENT expression (see Outcome #2) on normal lymphocytes were measured after Pemetrexed administration to evaluate if there was reproducible timing of maximum dCK expression, and to assess proper time interval between pemetrexed and gemcitabine for treatment of patients with advanced Non-Small Cell Lung Cancer (NSCLC). Values are calculated as ratio between thereshold cycles (number of polymerase chain reaction \[PCR\] cycles) with respect to a reference gene; in this case glyceraldehyde 3-phosphate dehydrogenase (GAPDH). |
| Mean Human Equilibrative Nucleoside Transporter 1 (hENT) Expression Evaluated at Cycle 1, Cycle 2, and Cycle 3 | pre-dose, 1, 2, 4, 6, 24, and 48 hours post-dose (3 cycles) | dCK (see Outcome #1)and hENT expression (see Outcome #2) on normal lymphocytes were measured after Pemetrexed administration to evaluate if there was reproducible timing of maximum dCK expression, and to assess proper time interval between pemetrexed and gemcitabine for treatment of patients with advanced Non-Small Cell Lung Cancer (NSCLC). Values are calculated as ratio between thereshold cycles (number of polymerase chain reaction \[PCR\] cycles) with respect to a reference gene; in this case glyceraldehyde 3-phosphate dehydrogenase (GAPDH). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Best Objective Tumor Response | baseline to measured response (every 14 days for 6 cycles) | Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria. |
Countries
Italy
Participant flow
Pre-assignment details
Of the 19 enrolled patients, 12 were enrolled before the protocol amendment was made effective (i.e. 2-weekly administration) and 7 were enrolled after the amendment (i.e. 3-weekly administration).
Participants by arm
| Arm | Count |
|---|---|
| Pemetrexed - Before Amendment 500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles or disease progression, unacceptable toxicity or patient decision to discontinue. | 12 |
| Pemetrexed - After Amendment 500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days x 6 cycles or disease progression, unacceptable toxicity or patient decision to discontinue. | 7 |
| Total | 19 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 7 |
| Overall Study | Disease Progression | 4 |
| Overall Study | Physician Decision | 2 |
Baseline characteristics
| Characteristic | Total | Pemetrexed - After Amendment | Pemetrexed - Before Amendment |
|---|---|---|---|
| Age Continuous | 69.2 years STANDARD_DEVIATION 8.9 | 69.4 years STANDARD_DEVIATION 6.45 | 69.1 years STANDARD_DEVIATION 10.34 |
| Blood Pressure Diastolic Blood Pressure (DBP) | 82.5 mmHg STANDARD_DEVIATION 8.37 | 83.6 mmHg STANDARD_DEVIATION 9.45 | 81.8 mmHg STANDARD_DEVIATION 7.97 |
| Blood Pressure Systolic Blood Pressure (SBP) | 141.6 mmHg STANDARD_DEVIATION 17.08 | 146.9 mmHg STANDARD_DEVIATION 21.54 | 138.0 mmHg STANDARD_DEVIATION 13.17 |
| Body Surface Area (BSA) | 1.7 square meters (m^2) STANDARD_DEVIATION 0.16 | 1.7 square meters (m^2) STANDARD_DEVIATION 0.13 | 1.7 square meters (m^2) STANDARD_DEVIATION 0.17 |
| Body Temperature | 36.0 degrees Celsius (°C) STANDARD_DEVIATION 0.49 | 35.9 degrees Celsius (°C) STANDARD_DEVIATION 0.36 | 36.1 degrees Celsius (°C) STANDARD_DEVIATION 0.58 |
| Disease Stages Not Known | 1 participants | 1 participants | 0 participants |
| Disease Stages Stage IA | 2 participants | 0 participants | 2 participants |
| Disease Stages Stage IB | 1 participants | 0 participants | 1 participants |
| Disease Stages Stage IIA | 1 participants | 0 participants | 1 participants |
| Disease Stages Stage IIB | 1 participants | 1 participants | 0 participants |
| Disease Stages Stage IIIA | 1 participants | 1 participants | 0 participants |
| Disease Stages Stage IIIB | 5 participants | 2 participants | 3 participants |
| Disease Stages Stage IV | 7 participants | 2 participants | 5 participants |
| Eastern Cooperative Oncology Group Performance Status 0 - Fully Active | 5 participants | 1 participants | 4 participants |
| Eastern Cooperative Oncology Group Performance Status 1 - Ambulatory, Restricted Strenuous Activity | 11 participants | 5 participants | 6 participants |
| Eastern Cooperative Oncology Group Performance Status 2 - Ambulatory, No Work Activities | 3 participants | 1 participants | 2 participants |
| Heart Rate | 81.1 beats per minute (bpm) STANDARD_DEVIATION 12.58 | 78.6 beats per minute (bpm) STANDARD_DEVIATION 8.52 | 82.9 beats per minute (bpm) STANDARD_DEVIATION 14.98 |
| Height | 166.4 centimeters (cm) STANDARD_DEVIATION 10.09 | 162.1 centimeters (cm) STANDARD_DEVIATION 9.04 | 169.2 centimeters (cm) STANDARD_DEVIATION 10.15 |
| Histopathological Grade G1 - Well-Differentiated | 2 participants | 1 participants | 1 participants |
| Histopathological Grade G2 - Moderately Differentiated | 3 participants | 1 participants | 2 participants |
| Histopathological Grade G3 - Poorly Differentiated | 5 participants | 3 participants | 2 participants |
| Histopathological Grade Not Done | 9 participants | 2 participants | 7 participants |
| Previous Anti-Tumor Treatment No | 6 participants | 1 participants | 5 participants |
| Previous Anti-Tumor Treatment Yes | 13 participants | 6 participants | 7 participants |
| Previous Surgery Surgery - No | 5 participants | 1 participants | 4 participants |
| Previous Surgery Surgery - Yes: Lobectomy | 6 participants | 3 participants | 3 participants |
| Previous Surgery Surgery - Yes: Other | 8 participants | 3 participants | 5 participants |
| Previous Surgery Surgery - Yes: Pneumonectomy | 1 participants | 1 participants | 0 participants |
| Previous Surgery Surgery - Yes: Radical | 9 participants | 4 participants | 5 participants |
| Race/Ethnicity Caucasian | 19 participants | 7 participants | 12 participants |
| Region of Enrollment Italy | 19 participants | 7 participants | 12 participants |
| Sex: Female, Male Female | 8 Participants | 5 Participants | 3 Participants |
| Sex: Female, Male Male | 11 Participants | 2 Participants | 9 Participants |
| Tumor Type Adenocarcinoma | 11 participants | 6 participants | 5 participants |
| Tumor Type Other | 2 participants | 0 participants | 2 participants |
| Tumor Type Squamous Cell Carcinoma | 6 participants | 1 participants | 5 participants |
| Weight | 68.7 kilograms (kg) STANDARD_DEVIATION 13.13 | 66.3 kilograms (kg) STANDARD_DEVIATION 9.43 | 70.2 kilograms (kg) STANDARD_DEVIATION 15.28 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 19 / 19 |
| serious Total, serious adverse events | 5 / 19 |
Outcome results
Primary
Mean Deoxycytidine Kinase (dCK) Expression Evaluated at Cycle 1, Cycle 2, and Cycle 3
dCK and hENT expression (see Outcome #2) on normal lymphocytes were measured after Pemetrexed administration to evaluate if there was reproducible timing of maximum dCK expression, and to assess proper time interval between pemetrexed and gemcitabine for treatment of patients with advanced Non-Small Cell Lung Cancer (NSCLC). Values are calculated as ratio between thereshold cycles (number of polymerase chain reaction \[PCR\] cycles) with respect to a reference gene; in this case glyceraldehyde 3-phosphate dehydrogenase (GAPDH).
Time frame: pre-dose, 1, 2, 4, 6, 24, and 48 hours post-dose (3 cycles)
Population: All participants who received at least one dose of study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| dCK - Cycle 1 | Mean Deoxycytidine Kinase (dCK) Expression Evaluated at Cycle 1, Cycle 2, and Cycle 3 | 1 Hour Post-Dose | 0.96 mRNA relative values (ratio with GAPDH) | Standard Deviation 0.04 |
| dCK - Cycle 1 | Mean Deoxycytidine Kinase (dCK) Expression Evaluated at Cycle 1, Cycle 2, and Cycle 3 | 6 Hours Post-Dose | 0.92 mRNA relative values (ratio with GAPDH) | Standard Deviation 0.03 |
| dCK - Cycle 1 | Mean Deoxycytidine Kinase (dCK) Expression Evaluated at Cycle 1, Cycle 2, and Cycle 3 | 4 Hours Post-Dose | 0.93 mRNA relative values (ratio with GAPDH) | Standard Deviation 0.04 |
| dCK - Cycle 1 | Mean Deoxycytidine Kinase (dCK) Expression Evaluated at Cycle 1, Cycle 2, and Cycle 3 | Pre-Dose | 0.92 mRNA relative values (ratio with GAPDH) | Standard Deviation 0.03 |
| dCK - Cycle 1 | Mean Deoxycytidine Kinase (dCK) Expression Evaluated at Cycle 1, Cycle 2, and Cycle 3 | 48 Hours Post-Dose | 0.97 mRNA relative values (ratio with GAPDH) | Standard Deviation 0.04 |
| dCK - Cycle 1 | Mean Deoxycytidine Kinase (dCK) Expression Evaluated at Cycle 1, Cycle 2, and Cycle 3 | 24 Hours Post-Dose | 0.96 mRNA relative values (ratio with GAPDH) | Standard Deviation 0.04 |
| dCK - Cycle 1 | Mean Deoxycytidine Kinase (dCK) Expression Evaluated at Cycle 1, Cycle 2, and Cycle 3 | 2 Hours Post-Dose | 0.96 mRNA relative values (ratio with GAPDH) | Standard Deviation 0.04 |
| dCK - Cycle 2 | Mean Deoxycytidine Kinase (dCK) Expression Evaluated at Cycle 1, Cycle 2, and Cycle 3 | 4 Hours Post-Dose | 0.94 mRNA relative values (ratio with GAPDH) | Standard Deviation 0.04 |
| dCK - Cycle 2 | Mean Deoxycytidine Kinase (dCK) Expression Evaluated at Cycle 1, Cycle 2, and Cycle 3 | Pre-Dose | 0.92 mRNA relative values (ratio with GAPDH) | Standard Deviation 0.03 |
| dCK - Cycle 2 | Mean Deoxycytidine Kinase (dCK) Expression Evaluated at Cycle 1, Cycle 2, and Cycle 3 | 1 Hour Post-Dose | 0.95 mRNA relative values (ratio with GAPDH) | Standard Deviation 0.03 |
| dCK - Cycle 2 | Mean Deoxycytidine Kinase (dCK) Expression Evaluated at Cycle 1, Cycle 2, and Cycle 3 | 2 Hours Post-Dose | 0.96 mRNA relative values (ratio with GAPDH) | Standard Deviation 0.04 |
| dCK - Cycle 2 | Mean Deoxycytidine Kinase (dCK) Expression Evaluated at Cycle 1, Cycle 2, and Cycle 3 | 6 Hours Post-Dose | 0.91 mRNA relative values (ratio with GAPDH) | Standard Deviation 0.04 |
| dCK - Cycle 2 | Mean Deoxycytidine Kinase (dCK) Expression Evaluated at Cycle 1, Cycle 2, and Cycle 3 | 24 Hours Post-Dose | 0.97 mRNA relative values (ratio with GAPDH) | Standard Deviation 0.03 |
| dCK - Cycle 2 | Mean Deoxycytidine Kinase (dCK) Expression Evaluated at Cycle 1, Cycle 2, and Cycle 3 | 48 Hours Post-Dose | 0.96 mRNA relative values (ratio with GAPDH) | Standard Deviation 0.04 |
| dCK - Cycle 3 | Mean Deoxycytidine Kinase (dCK) Expression Evaluated at Cycle 1, Cycle 2, and Cycle 3 | 6 Hours Post-Dose | 0.91 mRNA relative values (ratio with GAPDH) | Standard Deviation 0.03 |
| dCK - Cycle 3 | Mean Deoxycytidine Kinase (dCK) Expression Evaluated at Cycle 1, Cycle 2, and Cycle 3 | 1 Hour Post-Dose | 0.96 mRNA relative values (ratio with GAPDH) | Standard Deviation 0.03 |
| dCK - Cycle 3 | Mean Deoxycytidine Kinase (dCK) Expression Evaluated at Cycle 1, Cycle 2, and Cycle 3 | 48 Hours Post-Dose | 0.97 mRNA relative values (ratio with GAPDH) | Standard Deviation 0.03 |
| dCK - Cycle 3 | Mean Deoxycytidine Kinase (dCK) Expression Evaluated at Cycle 1, Cycle 2, and Cycle 3 | 24 Hours Post-Dose | 0.96 mRNA relative values (ratio with GAPDH) | Standard Deviation 0.03 |
| dCK - Cycle 3 | Mean Deoxycytidine Kinase (dCK) Expression Evaluated at Cycle 1, Cycle 2, and Cycle 3 | 4 Hours Post-Dose | 0.92 mRNA relative values (ratio with GAPDH) | Standard Deviation 0.03 |
| dCK - Cycle 3 | Mean Deoxycytidine Kinase (dCK) Expression Evaluated at Cycle 1, Cycle 2, and Cycle 3 | 2 Hours Post-Dose | 0.97 mRNA relative values (ratio with GAPDH) | Standard Deviation 0.02 |
| dCK - Cycle 3 | Mean Deoxycytidine Kinase (dCK) Expression Evaluated at Cycle 1, Cycle 2, and Cycle 3 | Pre-Dose | 0.92 mRNA relative values (ratio with GAPDH) | Standard Deviation 0.02 |
p-value: <0.001Repeated Measures Analysis of Variance
p-value: <0.001Repeated Measures Analysis of Variance
p-value: 0.03Repeated Measures Analysis of Variance
p-value: 0.166Repeated Measures Analysis of Variance
p-value: <0.001Repeated Measures Analysis of Variance
p-value: <0.001Repeated Measures Analysis of Variance
Primary
Mean Human Equilibrative Nucleoside Transporter 1 (hENT) Expression Evaluated at Cycle 1, Cycle 2, and Cycle 3
dCK (see Outcome #1)and hENT expression (see Outcome #2) on normal lymphocytes were measured after Pemetrexed administration to evaluate if there was reproducible timing of maximum dCK expression, and to assess proper time interval between pemetrexed and gemcitabine for treatment of patients with advanced Non-Small Cell Lung Cancer (NSCLC). Values are calculated as ratio between thereshold cycles (number of polymerase chain reaction \[PCR\] cycles) with respect to a reference gene; in this case glyceraldehyde 3-phosphate dehydrogenase (GAPDH).
Time frame: pre-dose, 1, 2, 4, 6, 24, and 48 hours post-dose (3 cycles)
Population: Number of participants who received at least one dose of study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| dCK - Cycle 1 | Mean Human Equilibrative Nucleoside Transporter 1 (hENT) Expression Evaluated at Cycle 1, Cycle 2, and Cycle 3 | 1 Hour Post-Dose | 0.88 mRNA relative values (ratio with GAPDH) | Standard Deviation 0.04 |
| dCK - Cycle 1 | Mean Human Equilibrative Nucleoside Transporter 1 (hENT) Expression Evaluated at Cycle 1, Cycle 2, and Cycle 3 | 6 Hours Post-Dose | 0.86 mRNA relative values (ratio with GAPDH) | Standard Deviation 0.04 |
| dCK - Cycle 1 | Mean Human Equilibrative Nucleoside Transporter 1 (hENT) Expression Evaluated at Cycle 1, Cycle 2, and Cycle 3 | 4 Hours Post-Dose | 0.86 mRNA relative values (ratio with GAPDH) | Standard Deviation 0.04 |
| dCK - Cycle 1 | Mean Human Equilibrative Nucleoside Transporter 1 (hENT) Expression Evaluated at Cycle 1, Cycle 2, and Cycle 3 | Pre-Dose | 0.86 mRNA relative values (ratio with GAPDH) | Standard Deviation 0.03 |
| dCK - Cycle 1 | Mean Human Equilibrative Nucleoside Transporter 1 (hENT) Expression Evaluated at Cycle 1, Cycle 2, and Cycle 3 | 48 Hours Post-Dose | 0.90 mRNA relative values (ratio with GAPDH) | Standard Deviation 0.04 |
| dCK - Cycle 1 | Mean Human Equilibrative Nucleoside Transporter 1 (hENT) Expression Evaluated at Cycle 1, Cycle 2, and Cycle 3 | 24 Hours Post-Dose | 0.89 mRNA relative values (ratio with GAPDH) | Standard Deviation 0.04 |
| dCK - Cycle 1 | Mean Human Equilibrative Nucleoside Transporter 1 (hENT) Expression Evaluated at Cycle 1, Cycle 2, and Cycle 3 | 2 Hours Post-Dose | 0.88 mRNA relative values (ratio with GAPDH) | Standard Deviation 0.04 |
| dCK - Cycle 2 | Mean Human Equilibrative Nucleoside Transporter 1 (hENT) Expression Evaluated at Cycle 1, Cycle 2, and Cycle 3 | 4 Hours Post-Dose | 0.88 mRNA relative values (ratio with GAPDH) | Standard Deviation 0.05 |
| dCK - Cycle 2 | Mean Human Equilibrative Nucleoside Transporter 1 (hENT) Expression Evaluated at Cycle 1, Cycle 2, and Cycle 3 | Pre-Dose | 0.86 mRNA relative values (ratio with GAPDH) | Standard Deviation 0.03 |
| dCK - Cycle 2 | Mean Human Equilibrative Nucleoside Transporter 1 (hENT) Expression Evaluated at Cycle 1, Cycle 2, and Cycle 3 | 1 Hour Post-Dose | 0.89 mRNA relative values (ratio with GAPDH) | Standard Deviation 0.04 |
| dCK - Cycle 2 | Mean Human Equilibrative Nucleoside Transporter 1 (hENT) Expression Evaluated at Cycle 1, Cycle 2, and Cycle 3 | 2 Hours Post-Dose | 0.90 mRNA relative values (ratio with GAPDH) | Standard Deviation 0.04 |
| dCK - Cycle 2 | Mean Human Equilibrative Nucleoside Transporter 1 (hENT) Expression Evaluated at Cycle 1, Cycle 2, and Cycle 3 | 6 Hours Post-Dose | 0.86 mRNA relative values (ratio with GAPDH) | Standard Deviation 0.04 |
| dCK - Cycle 2 | Mean Human Equilibrative Nucleoside Transporter 1 (hENT) Expression Evaluated at Cycle 1, Cycle 2, and Cycle 3 | 24 Hours Post-Dose | 0.91 mRNA relative values (ratio with GAPDH) | Standard Deviation 0.04 |
| dCK - Cycle 2 | Mean Human Equilibrative Nucleoside Transporter 1 (hENT) Expression Evaluated at Cycle 1, Cycle 2, and Cycle 3 | 48 Hours Post-Dose | 0.91 mRNA relative values (ratio with GAPDH) | Standard Deviation 0.04 |
| dCK - Cycle 3 | Mean Human Equilibrative Nucleoside Transporter 1 (hENT) Expression Evaluated at Cycle 1, Cycle 2, and Cycle 3 | 6 Hours Post-Dose | 0.86 mRNA relative values (ratio with GAPDH) | Standard Deviation 0.02 |
| dCK - Cycle 3 | Mean Human Equilibrative Nucleoside Transporter 1 (hENT) Expression Evaluated at Cycle 1, Cycle 2, and Cycle 3 | 1 Hour Post-Dose | 0.90 mRNA relative values (ratio with GAPDH) | Standard Deviation 0.03 |
| dCK - Cycle 3 | Mean Human Equilibrative Nucleoside Transporter 1 (hENT) Expression Evaluated at Cycle 1, Cycle 2, and Cycle 3 | 48 Hours Post-Dose | 0.91 mRNA relative values (ratio with GAPDH) | Standard Deviation 0.02 |
| dCK - Cycle 3 | Mean Human Equilibrative Nucleoside Transporter 1 (hENT) Expression Evaluated at Cycle 1, Cycle 2, and Cycle 3 | 24 Hours Post-Dose | 0.91 mRNA relative values (ratio with GAPDH) | Standard Deviation 0.02 |
| dCK - Cycle 3 | Mean Human Equilibrative Nucleoside Transporter 1 (hENT) Expression Evaluated at Cycle 1, Cycle 2, and Cycle 3 | 4 Hours Post-Dose | 0.86 mRNA relative values (ratio with GAPDH) | Standard Deviation 0.03 |
| dCK - Cycle 3 | Mean Human Equilibrative Nucleoside Transporter 1 (hENT) Expression Evaluated at Cycle 1, Cycle 2, and Cycle 3 | 2 Hours Post-Dose | 0.90 mRNA relative values (ratio with GAPDH) | Standard Deviation 0.04 |
| dCK - Cycle 3 | Mean Human Equilibrative Nucleoside Transporter 1 (hENT) Expression Evaluated at Cycle 1, Cycle 2, and Cycle 3 | Pre-Dose | 0.87 mRNA relative values (ratio with GAPDH) | Standard Deviation 0.02 |
p-value: <0.001Repeated Measures Analysis of Variance
p-value: <0.001Repeated Measures Analysis of Variance
p-value: 0.333Repeated Measures Analysis of Variance
p-value: 0.849Repeated Measures Analysis of Variance
p-value: <0.001Repeated Measures Analysis of Variance
p-value: <0.001Repeated Measures Analysis of Variance
Secondary
Best Objective Tumor Response
Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.
Time frame: baseline to measured response (every 14 days for 6 cycles)
Population: Number of participants who received at least one dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| dCK - Cycle 1 | Best Objective Tumor Response | Partial Response | 1 participants |
| dCK - Cycle 1 | Best Objective Tumor Response | Progressive Disease | 3 participants |
| dCK - Cycle 1 | Best Objective Tumor Response | Stable Disease | 2 participants |
| dCK - Cycle 1 | Best Objective Tumor Response | Early Death | 1 participants |
| dCK - Cycle 1 | Best Objective Tumor Response | Unconfirmed Stable Disease | 5 participants |
| dCK - Cycle 2 | Best Objective Tumor Response | Early Death | 0 participants |
| dCK - Cycle 2 | Best Objective Tumor Response | Unconfirmed Stable Disease | 3 participants |
| dCK - Cycle 2 | Best Objective Tumor Response | Partial Response | 0 participants |
| dCK - Cycle 2 | Best Objective Tumor Response | Stable Disease | 4 participants |
| dCK - Cycle 2 | Best Objective Tumor Response | Progressive Disease | 0 participants |