Multiple Myeloma
Conditions
Keywords
IGF-1R inhibitor, CP-751871, multiple myeloma
Brief summary
This study represents the first-in-human study for CP-751,871. The study aimed to define the safety, tolerability, and maximum tolerated dose of CP-751,871 in patients with multiple myeloma through a dose escalation design.
Interventions
DRUGCP-751,871
CP-751,871 was given at doses ranging from 0.025 mg/kg up to 20 mg/kg IV every 4 weeks until disease progression or lack of tolerability
Sponsors
Pfizer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Previously treated multiple myeloma with a quantifiable serum (M spike ≥ 1 g/dL) and/or urine (≥ 200 mg/24-hr) paraprotein * Adequate bone marrow, renal, liver and cardiac function * Eastern Cooperative Oncology Group \[ECOG\] performance status less than or equal to 2
Exclusion criteria
* Prior allogeneic stem cell transplant (alloSCT) * Myelosuppressive chemotherapy or immunotherapy within 3 weeks prior to treatment with CP-751,871 * Prior organ allograft * Concurrent use of insulin, oral hypoglycemic medication, growth hormone (GH), or growth hormone inhibitors * Female patients who are pregnant or lactating
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Tolerated Dose (MTD) | Baseline up to Cycle 1 (Week 4 or Week 8) | The highest dose level at which not more than 1 dose-limiting toxicity (DLT) was observed during Cycle 1 in 6 participants |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Single Dose Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for CP-751,871 | Cycle 1: predose; 1; 24; 48; 72; 168; 336; 504, 672 and 1008 (for participants with an up to 8-week Cycle 1 only) hours postdose | — |
| Single Dose Volume of Distribution (Vz) for CP-751,871 | Cycle 1: predose; 1; 24; 48; 72; 168; 336; 504 and 672 and 1008 (for participants with an up to 8-week Cycle 1 only) hours postdose | — |
| Single Dose Plasma Decay Half-life (t1/2) for CP-751,871 | Cycle 1: predose; 1; 24; 48; 72; 168; 336; 504 and 672 and 1008 (for participants with an up to 8-week Cycle 1 only) hours postdose | — |
| Single Dose Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] for CP-751,871 | Cycle 1: predose; 1; 24; 48; 72; 168; 336; 504 and 672 and 1008 (for participants with an up to 8-week Cycle 1 only) hours postdose | — |
| Single Dose Volume of Distribution at Steady State (Vss) for CP-751,871 | Cycle 1: predose; 1; 24; 48; 72; 168; 336; 504 and 672 and 1008 (for participants with an up to 8-week Cycle 1 only) hours postdose | — |
| Single Dose Systemic Clearance (CL) for CP-751,871 | Cycle 1: predose; 1; 24; 48; 72; 168; 336; 504 and 672 and 1008 (for participants with an up to 8-week Cycle 1 only) hours postdose | — |
| Single Dose End-of-infusion Concentration (Cinf) for CP-751,871 | 1 hour postdose in Cycle 1 | — |
| Multiple Dose Minimum Observed Plasma Trough Concentration (Cmin) for CP-751,871 | 0 hour (predose) in Cycles 2 up to 16 | — |
| Pharmacodynamic-based Dose | Cycle 1 (Week 4 or Week 8) | The dose associated with PK exposure that was associated with 80% of the maximal effect based on down-regulation of insulin-like growth factor 1 receptor (IGF-1R) expression |
| Human Anti-human Antibody (HAHA) Response to CP-751,871 | 30 minutes predose in Cycle 1 and subsequent cycles, end of study visit (Days 30 and 60) for dose levels below 0.8 mg/kg; 30 minutes predose in Cycle 1 and last scheduled follow-up visit for dose levels greater than or equal to 0.8 mg/kg | — |
| Percentage of Participants With Objective Response (OR) | Baseline, Day 1 at predose/cycle, end of study (30-60 days post last dose) | Percentage of participants with OR based on assessment of confirmed complete remission (CR) or confirmed partial remission (PR) according to Southwest Oncology Group (SWOG) criteria. CR were those with absence of bone marrow or blood findings of multiple myeloma. PR were those with a 50-74% reduction in the quantitative immunoglobulin, and if present, a 50-89% reduction in the urine M-component (Bence-Jones protein). |
| Time to Disease Progression | Baseline up to end of treatment | Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to cancer, whichever came first. Tumor progression was determined from oncologic assessment data (where data met the criteria for progressive disease \[PD\]) |
| Multiple Dose Cinf for CP-751,871 | 1 hour postdose in Cycles 2 up to 16 | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CP-751,871 CP-751,871 0.025, 0.05, 0.1, 0.2, 0.4, 0.8, 1.5, 3 and 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks); CP-751,871 10 and 20 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks) | 47 |
| Total | 47 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 3 |
| Overall Study | Death | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Other | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 3 | 2 |
| Overall Study | Progressive disease | 3 | 4 | 1 | 2 | 1 | 2 | 1 | 2 | 1 | 3 | 3 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 2 | 0 | 2 |
Baseline characteristics
| Characteristic | CP-751,871 |
|---|---|
| Age Continuous | 61.3 years STANDARD_DEVIATION 9.4 |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 45 / 47 |
| serious Total, serious adverse events | 21 / 47 |
Outcome results
Primary
Maximum Tolerated Dose (MTD)
The highest dose level at which not more than 1 dose-limiting toxicity (DLT) was observed during Cycle 1 in 6 participants
Time frame: Baseline up to Cycle 1 (Week 4 or Week 8)
Population: All participants who received at least 1 dose of study drug CP-751,871.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CP-751,871 0.025-20 mg/kg | Maximum Tolerated Dose (MTD) | NA mg/kg |
Secondary
Human Anti-human Antibody (HAHA) Response to CP-751,871
Time frame: 30 minutes predose in Cycle 1 and subsequent cycles, end of study visit (Days 30 and 60) for dose levels below 0.8 mg/kg; 30 minutes predose in Cycle 1 and last scheduled follow-up visit for dose levels greater than or equal to 0.8 mg/kg
Population: All treated participants with HAHA samples collected at time points when circulating CP-751,871 concentrations were below the lower limit of quantification.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CP-751,871 0.025-20 mg/kg | Human Anti-human Antibody (HAHA) Response to CP-751,871 | NA |
Secondary
Multiple Dose Cinf for CP-751,871
Time frame: 1 hour postdose in Cycles 2 up to 16
Population: Multiple dose Cinf data were listed for individual subjects, however were not summarized by descriptive statistics.
Secondary
Multiple Dose Minimum Observed Plasma Trough Concentration (Cmin) for CP-751,871
Time frame: 0 hour (predose) in Cycles 2 up to 16
Population: Multiple dose Cmin data were listed for individual subjects, however were not summarized by descriptive statistics.
Secondary
Percentage of Participants With Objective Response (OR)
Percentage of participants with OR based on assessment of confirmed complete remission (CR) or confirmed partial remission (PR) according to Southwest Oncology Group (SWOG) criteria. CR were those with absence of bone marrow or blood findings of multiple myeloma. PR were those with a 50-74% reduction in the quantitative immunoglobulin, and if present, a 50-89% reduction in the urine M-component (Bence-Jones protein).
Time frame: Baseline, Day 1 at predose/cycle, end of study (30-60 days post last dose)
Population: All participants who completed a minimum of 1 cycle of treatment were evaluable for response. Participants who developed early progressive disease (regardless of the duration of study treatment) prior to response evaluation were also evaluable for response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CP-751,871 0.025-20 mg/kg | Percentage of Participants With Objective Response (OR) | 0 percentage of participants |
| CP-751,871 0.05 mg/kg | Percentage of Participants With Objective Response (OR) | 0 percentage of participants |
| CP-751,871 0.1 mg/kg | Percentage of Participants With Objective Response (OR) | 0 percentage of participants |
| CP-751,871 0.2 mg/kg | Percentage of Participants With Objective Response (OR) | 0 percentage of participants |
| CP-751,871 0.4 mg/kg | Percentage of Participants With Objective Response (OR) | 0 percentage of participants |
| CP-751,871 0.8 mg/kg | Percentage of Participants With Objective Response (OR) | 0 percentage of participants |
| CP-751,871 1.5 mg/kg | Percentage of Participants With Objective Response (OR) | 0 percentage of participants |
| CP-751,871 3 mg/kg | Percentage of Participants With Objective Response (OR) | 0 percentage of participants |
| CP-751,871 6 mg/kg | Percentage of Participants With Objective Response (OR) | 0 percentage of participants |
| CP-751,871 10 mg/kg | Percentage of Participants With Objective Response (OR) | 0 percentage of participants |
| CP-751,871 20 mg/kg | Percentage of Participants With Objective Response (OR) | 0 percentage of participants |
Secondary
Pharmacodynamic-based Dose
The dose associated with PK exposure that was associated with 80% of the maximal effect based on down-regulation of insulin-like growth factor 1 receptor (IGF-1R) expression
Time frame: Cycle 1 (Week 4 or Week 8)
Population: Data from analysis of the PK/pharmacodynamic relationship could not permit a reliable estimate of the pharmacodynamic-based dose.
Secondary
Single Dose Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] for CP-751,871
Time frame: Cycle 1: predose; 1; 24; 48; 72; 168; 336; 504 and 672 and 1008 (for participants with an up to 8-week Cycle 1 only) hours postdose
Population: All participants treated who had at least 1 of the PK parameters of primary interest.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CP-751,871 0.025-20 mg/kg | Single Dose Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] for CP-751,871 | 249 mg•hr/L | Standard Deviation 42.5 |
| CP-751,871 0.05 mg/kg | Single Dose Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] for CP-751,871 | 1121 mg•hr/L | Standard Deviation 645 |
| CP-751,871 0.1 mg/kg | Single Dose Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] for CP-751,871 | 2191 mg•hr/L | Standard Deviation 1396 |
| CP-751,871 0.2 mg/kg | Single Dose Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] for CP-751,871 | 11035 mg•hr/L | — |
| CP-751,871 0.4 mg/kg | Single Dose Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] for CP-751,871 | 15025 mg•hr/L | Standard Deviation 3673 |
| CP-751,871 0.8 mg/kg | Single Dose Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] for CP-751,871 | 32360 mg•hr/L | Standard Deviation 4023 |
| CP-751,871 1.5 mg/kg | Single Dose Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] for CP-751,871 | 46275 mg•hr/L | Standard Deviation 16606 |
Secondary
Single Dose Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for CP-751,871
Time frame: Cycle 1: predose; 1; 24; 48; 72; 168; 336; 504, 672 and 1008 (for participants with an up to 8-week Cycle 1 only) hours postdose
Population: All participants treated who had at least 1 of the pharmacokinetic (PK) parameters of primary interest.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CP-751,871 0.025-20 mg/kg | Single Dose Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for CP-751,871 | 101 milligram•hour/liter (mg•hr/L) | — |
| CP-751,871 0.05 mg/kg | Single Dose Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for CP-751,871 | 202 milligram•hour/liter (mg•hr/L) | Standard Deviation 29.2 |
| CP-751,871 0.1 mg/kg | Single Dose Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for CP-751,871 | 1016 milligram•hour/liter (mg•hr/L) | Standard Deviation 583 |
| CP-751,871 0.2 mg/kg | Single Dose Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for CP-751,871 | 2079 milligram•hour/liter (mg•hr/L) | Standard Deviation 1413 |
| CP-751,871 0.4 mg/kg | Single Dose Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for CP-751,871 | 8380 milligram•hour/liter (mg•hr/L) | Standard Deviation 4533 |
| CP-751,871 0.8 mg/kg | Single Dose Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for CP-751,871 | 15436 milligram•hour/liter (mg•hr/L) | Standard Deviation 6406 |
| CP-751,871 1.5 mg/kg | Single Dose Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for CP-751,871 | 26144 milligram•hour/liter (mg•hr/L) | Standard Deviation 2672 |
| CP-751,871 3 mg/kg | Single Dose Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for CP-751,871 | 38700 milligram•hour/liter (mg•hr/L) | Standard Deviation 15019 |
| CP-751,871 6 mg/kg | Single Dose Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for CP-751,871 | 95565 milligram•hour/liter (mg•hr/L) | Standard Deviation 25891 |
Secondary
Single Dose End-of-infusion Concentration (Cinf) for CP-751,871
Time frame: 1 hour postdose in Cycle 1
Population: All participants treated who had at least 1 concentration.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CP-751,871 0.025-20 mg/kg | Single Dose End-of-infusion Concentration (Cinf) for CP-751,871 | 0 milligram/liter (mg/L) | — |
| CP-751,871 0.05 mg/kg | Single Dose End-of-infusion Concentration (Cinf) for CP-751,871 | 0.381 milligram/liter (mg/L) | Standard Deviation 0.448 |
| CP-751,871 0.1 mg/kg | Single Dose End-of-infusion Concentration (Cinf) for CP-751,871 | 5.32 milligram/liter (mg/L) | Standard Deviation 6.85 |
| CP-751,871 0.2 mg/kg | Single Dose End-of-infusion Concentration (Cinf) for CP-751,871 | 5.36 milligram/liter (mg/L) | Standard Deviation 1.52 |
| CP-751,871 0.4 mg/kg | Single Dose End-of-infusion Concentration (Cinf) for CP-751,871 | 6.66 milligram/liter (mg/L) | Standard Deviation 2.84 |
| CP-751,871 0.8 mg/kg | Single Dose End-of-infusion Concentration (Cinf) for CP-751,871 | 14.6 milligram/liter (mg/L) | — |
| CP-751,871 1.5 mg/kg | Single Dose End-of-infusion Concentration (Cinf) for CP-751,871 | 26.0 milligram/liter (mg/L) | Standard Deviation 9.03 |
| CP-751,871 3 mg/kg | Single Dose End-of-infusion Concentration (Cinf) for CP-751,871 | 62.7 milligram/liter (mg/L) | Standard Deviation 13.5 |
| CP-751,871 6 mg/kg | Single Dose End-of-infusion Concentration (Cinf) for CP-751,871 | 159 milligram/liter (mg/L) | Standard Deviation 57.2 |
| CP-751,871 10 mg/kg | Single Dose End-of-infusion Concentration (Cinf) for CP-751,871 | 165 milligram/liter (mg/L) | Standard Deviation 57.3 |
| CP-751,871 20 mg/kg | Single Dose End-of-infusion Concentration (Cinf) for CP-751,871 | 238 milligram/liter (mg/L) | Standard Deviation 215 |
Secondary
Single Dose Plasma Decay Half-life (t1/2) for CP-751,871
Time frame: Cycle 1: predose; 1; 24; 48; 72; 168; 336; 504 and 672 and 1008 (for participants with an up to 8-week Cycle 1 only) hours postdose
Population: All participants treated who had at least 1 of the PK parameters of primary interest.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CP-751,871 0.025-20 mg/kg | Single Dose Plasma Decay Half-life (t1/2) for CP-751,871 | 1.70 days | Standard Deviation 0.631 |
| CP-751,871 0.05 mg/kg | Single Dose Plasma Decay Half-life (t1/2) for CP-751,871 | 4.63 days | Standard Deviation 2.88 |
| CP-751,871 0.1 mg/kg | Single Dose Plasma Decay Half-life (t1/2) for CP-751,871 | 4.10 days | Standard Deviation 0.0566 |
| CP-751,871 0.2 mg/kg | Single Dose Plasma Decay Half-life (t1/2) for CP-751,871 | 9.15 days | — |
| CP-751,871 0.4 mg/kg | Single Dose Plasma Decay Half-life (t1/2) for CP-751,871 | 12.7 days | Standard Deviation 1.59 |
| CP-751,871 0.8 mg/kg | Single Dose Plasma Decay Half-life (t1/2) for CP-751,871 | 12.7 days | Standard Deviation 4.61 |
| CP-751,871 1.5 mg/kg | Single Dose Plasma Decay Half-life (t1/2) for CP-751,871 | 12.1 days | Standard Deviation 3.42 |
Secondary
Single Dose Systemic Clearance (CL) for CP-751,871
Time frame: Cycle 1: predose; 1; 24; 48; 72; 168; 336; 504 and 672 and 1008 (for participants with an up to 8-week Cycle 1 only) hours postdose
Population: All participants treated who had at least 1 of the PK parameters of primary interest.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CP-751,871 0.025-20 mg/kg | Single Dose Systemic Clearance (CL) for CP-751,871 | 19.7 milliliter/day/kilogram (mL/day/kg) | Standard Deviation 3.65 |
| CP-751,871 0.05 mg/kg | Single Dose Systemic Clearance (CL) for CP-751,871 | 11.9 milliliter/day/kilogram (mL/day/kg) | Standard Deviation 8.75 |
| CP-751,871 0.1 mg/kg | Single Dose Systemic Clearance (CL) for CP-751,871 | 10.9 milliliter/day/kilogram (mL/day/kg) | Standard Deviation 5.09 |
| CP-751,871 0.2 mg/kg | Single Dose Systemic Clearance (CL) for CP-751,871 | 3.57 milliliter/day/kilogram (mL/day/kg) | — |
| CP-751,871 0.4 mg/kg | Single Dose Systemic Clearance (CL) for CP-751,871 | 4.98 milliliter/day/kilogram (mL/day/kg) | Standard Deviation 1.14 |
| CP-751,871 0.8 mg/kg | Single Dose Systemic Clearance (CL) for CP-751,871 | 4.50 milliliter/day/kilogram (mL/day/kg) | Standard Deviation 0.602 |
| CP-751,871 1.5 mg/kg | Single Dose Systemic Clearance (CL) for CP-751,871 | 5.71 milliliter/day/kilogram (mL/day/kg) | Standard Deviation 1.83 |
Secondary
Single Dose Volume of Distribution at Steady State (Vss) for CP-751,871
Time frame: Cycle 1: predose; 1; 24; 48; 72; 168; 336; 504 and 672 and 1008 (for participants with an up to 8-week Cycle 1 only) hours postdose
Population: All participants treated who had at least 1 of the PK parameters of primary interest.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CP-751,871 0.025-20 mg/kg | Single Dose Volume of Distribution at Steady State (Vss) for CP-751,871 | 46.0 mL/kg | Standard Deviation 11.9 |
| CP-751,871 0.05 mg/kg | Single Dose Volume of Distribution at Steady State (Vss) for CP-751,871 | 65.9 mL/kg | Standard Deviation 24.7 |
| CP-751,871 0.1 mg/kg | Single Dose Volume of Distribution at Steady State (Vss) for CP-751,871 | 72.6 mL/kg | Standard Deviation 21.1 |
| CP-751,871 0.2 mg/kg | Single Dose Volume of Distribution at Steady State (Vss) for CP-751,871 | 50.9 mL/kg | — |
| CP-751,871 0.4 mg/kg | Single Dose Volume of Distribution at Steady State (Vss) for CP-751,871 | 81.4 mL/kg | Standard Deviation 16.6 |
| CP-751,871 0.8 mg/kg | Single Dose Volume of Distribution at Steady State (Vss) for CP-751,871 | 69.4 mL/kg | Standard Deviation 16 |
| CP-751,871 1.5 mg/kg | Single Dose Volume of Distribution at Steady State (Vss) for CP-751,871 | 92.1 mL/kg | Standard Deviation 15.8 |
Secondary
Single Dose Volume of Distribution (Vz) for CP-751,871
Time frame: Cycle 1: predose; 1; 24; 48; 72; 168; 336; 504 and 672 and 1008 (for participants with an up to 8-week Cycle 1 only) hours postdose
Population: All participants treated who had at least 1 of the PK parameters of primary interest.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CP-751,871 0.025-20 mg/kg | Single Dose Volume of Distribution (Vz) for CP-751,871 | 46.3 milliliter/kilogram (mL/kg ) | Standard Deviation 12.2 |
| CP-751,871 0.05 mg/kg | Single Dose Volume of Distribution (Vz) for CP-751,871 | 63.3 milliliter/kilogram (mL/kg ) | Standard Deviation 26.4 |
| CP-751,871 0.1 mg/kg | Single Dose Volume of Distribution (Vz) for CP-751,871 | 64.5 milliliter/kilogram (mL/kg ) | Standard Deviation 29.7 |
| CP-751,871 0.2 mg/kg | Single Dose Volume of Distribution (Vz) for CP-751,871 | 52.0 milliliter/kilogram (mL/kg ) | — |
| CP-751,871 0.4 mg/kg | Single Dose Volume of Distribution (Vz) for CP-751,871 | 90.0 milliliter/kilogram (mL/kg ) | Standard Deviation 18.2 |
| CP-751,871 0.8 mg/kg | Single Dose Volume of Distribution (Vz) for CP-751,871 | 81.9 milliliter/kilogram (mL/kg ) | Standard Deviation 28.5 |
| CP-751,871 1.5 mg/kg | Single Dose Volume of Distribution (Vz) for CP-751,871 | 93.0 milliliter/kilogram (mL/kg ) | Standard Deviation 14.3 |
Secondary
Time to Disease Progression
Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to cancer, whichever came first. Tumor progression was determined from oncologic assessment data (where data met the criteria for progressive disease \[PD\])
Time frame: Baseline up to end of treatment
Population: A substantial number of participants were not followed-up prior to disease progression, therefore time to disease progression was not estimated.