CP-751,871 Treatment For Patients With Multiple Myeloma

NCT01536145

Last updated date
Study Location
Pfizer Investigational Site
Phoenix, Arizona, 85054, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Multiple Myeloma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Advanced Information
Descriptive Information
Brief Title  ICMJE CP-751,871 Treatment For Patients With Multiple Myeloma
Official Title  ICMJE An Open Label Phase I Study Of CP-751,871 In Patients With Multiple Myeloma
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Multiple Myeloma
Intervention  ICMJE Drug: CP-751,871
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
Study Arms  ICMJE Experimental: Single agent CP-751,871
dose escalation design
Intervention: Drug: CP-751,871
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 16, 2012)
47
Original Actual Enrollment  ICMJE
 (submitted: February 15, 2012)
50
Actual Study Completion Date  ICMJE June 2008
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01536145
Other Study ID Numbers  ICMJE A4021001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP