NCT01536145 · REGISTRY CONDITION SEARCH

CP-751,871 Treatment For Patients With Multiple Myeloma

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE1
Status at capture: COMPLETED
Registry last update: 2013-03-15

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Maximum Tolerated Dose (MTD)

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outcome · POSTED

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

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outcome · POSTED

Single Dose Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for CP-751,871

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outcome · POSTED

Single Dose Volume of Distribution (Vz) for CP-751,871

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outcome · POSTED

Single Dose Plasma Decay Half-life (t1/2) for CP-751,871

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outcome · POSTED

Single Dose Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] for CP-751,871

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outcome · POSTED

Single Dose Volume of Distribution at Steady State (Vss) for CP-751,871

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outcome · POSTED

Single Dose Systemic Clearance (CL) for CP-751,871

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outcome · POSTED

Multiple Dose Cinf for CP-751,871

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outcome · POSTED

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

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outcome · POSTED

Pharmacodynamic-based Dose

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outcome · POSTED

Human Anti-human Antibody (HAHA) Response to CP-751,871

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outcome · POSTED

Percentage of Participants With Objective Response (OR)

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outcome · POSTED

Time to Disease Progression

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

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
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
dose escalation design
intervention Names
Drug: CP-751,871
label
Single agent CP-751,871
type
EXPERIMENTAL

interventions

arm Group Labels
Single agent CP-751,871
description
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
name
CP-751,871
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 47
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
The highest dose level at which not more than 1 dose-limiting toxicity (DLT) was observed during Cycle 1 in 6 participants
measure
Maximum Tolerated Dose (MTD)
time Frame
Baseline up to Cycle 1 (Week 4 or Week 8)

secondary Outcomes

measure
Single Dose End-of-infusion Concentration (Cinf) for CP-751,871
time Frame
1 hour postdose in Cycle 1
measure
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
measure
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
measure
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
measure
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
measure
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
measure
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
measure
Multiple Dose Cinf for CP-751,871
time Frame
1 hour postdose in Cycles 2 up to 16
measure
Multiple Dose Minimum Observed Plasma Trough Concentration (Cmin) for CP-751,871
time Frame
0 hour (predose) in Cycles 2 up to 16
description
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
measure
Pharmacodynamic-based Dose
time Frame
Cycle 1 (Week 4 or Week 8)
measure
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
description
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).
measure
Percentage of Participants With Objective Response (OR)
time Frame
Baseline, Day 1 at predose/cycle, end of study (30-60 days post last dose)

Full study description

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.

Source references