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


Phase 1
18 Years
N/A
Not Enrolling
Both
Multiple Myeloma

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum Tolerated Dose (MTD)

Outcome Description:

The highest dose level at which not more than 1 dose-limiting toxicity (DLT) was observed during Cycle 1 in 6 participants

Outcome Time Frame:

Baseline up to Cycle 1 (Week 4 or Week 8)

Safety Issue:

Yes

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

A4021001

NCT ID:

NCT01536145

Start Date:

December 2003

Completion Date:

June 2008

Related Keywords:

  • Multiple Myeloma
  • IGF-1R inhibitor
  • CP-751871
  • multiple myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location
Pfizer Investigational Site Rochester, Minnesota  55905
Pfizer Investigational Site Bronx, New York  10461
Pfizer Investigational Site Flagstaff, Arizona  86001
Pfizer Investigational Site Clearwater, Florida  33761
Pfizer Investigational Site North Adams, Massachusetts  01247