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Completed

NCT Number: NCT01536145

CP-751,871 Treatment For Patients With Multiple Myeloma

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.

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site, Phoenix, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CP-751,871

Drug

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

Primary outcomes

  1. Maximum Tolerated Dose (MTD)

    Time frame: 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 outcomes

  1. Single Dose End-of-infusion Concentration (Cinf) for CP-751,871

    Time frame: 1 hour postdose in Cycle 1

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. Multiple Dose Cinf for CP-751,871

    Time frame: 1 hour postdose in Cycles 2 up to 16

  9. Multiple Dose Minimum Observed Plasma Trough Concentration (Cmin) for CP-751,871

    Time frame: 0 hour (predose) in Cycles 2 up to 16

  10. Pharmacodynamic-based Dose

    Time frame: 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

  11. 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

  12. Percentage of Participants With Objective Response (OR)

    Time frame: 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).

  13. Time to Disease Progression

    Time frame: 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])

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

An Open Label Phase I Study Of CP-751,871 In Patients With Multiple Myeloma

Important dates

Study start
2003
Primary completion
2008
Study completion
2008
First posted
Feb 20, 2012
Registry last updated
Mar 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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