CP-751,871 Treatment For Patients With Multiple Myeloma

Pfizer

Status and phase: Completed; Phase 1

Conditions: Multiple Myeloma

Treatments: Drug: CP-751,871

Study type: Interventional

Funder types: Industry

Identifiers

NCT01536145

A4021001

Details and patient eligibility

About

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.

Enrollment: 47 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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47 participants in 1 patient group

Single agent CP-751,871

Experimental group

Description:

dose escalation design

Treatment:

Drug: CP-751,871