Phase 1
Completed N=47
CP-751,871 Treatment For Patients With Multiple Myeloma
Source: ClinicalTrials.gov NCT01536145 ↗Enrolled (actual)
47
Serious AEs
44.7%
Results posted
Feb 2013
Primary outcomePrimary: Maximum Tolerated Dose (MTD) — NA mg/kg
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Tolerated Dose (MTD) |
NA | — |
| SECONDARY Single Dose End-of-infusion Concentration (Cinf) for CP-751,871 |
0; 0.381; 5.32; 5.36; 6.66; 14.6 | — |
| SECONDARY Single Dose Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for CP-751,871 |
101; 202; 1016; 2079; 8380; 15436 | — |
| SECONDARY Single Dose Volume of Distribution (Vz) for CP-751,871 |
46.3; 63.3; 64.5; 52.0; 90.0; 81.9 | — |
| SECONDARY Single Dose Plasma Decay Half-life (t1/2) for CP-751,871 |
1.70; 4.63; 4.10; 9.15; 12.7; 12.7 | — |
| SECONDARY Single Dose Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] for CP-751,871 |
249; 1121; 2191; 11035; 15025; 32360 | — |
| SECONDARY Single Dose Volume of Distribution at Steady State (Vss) for CP-751,871 |
46.0; 65.9; 72.6; 50.9; 81.4; 69.4 | — |
| SECONDARY Single Dose Systemic Clearance (CL) for CP-751,871 |
19.7; 11.9; 10.9; 3.57; 4.98; 4.50 | — |
| SECONDARY Multiple Dose Cinf for CP-751,871 |
— | — |
| SECONDARY Multiple Dose Minimum Observed Plasma Trough Concentration (Cmin) for CP-751,871 |
— | — |
| SECONDARY Pharmacodynamic-based Dose |
— | — |
| SECONDARY Human Anti-human Antibody (HAHA) Response to CP-751,871 |
NA | — |
| SECONDARY Percentage of Participants With Objective Response (OR) |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Time to Disease Progression |
— | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01536145). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.