CP-751,871 In Combination With Docetaxel In Advance Non-hematologic Malignancies

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NCT01653158

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Study Location
Pfizer Investigational Site
Sutton, Surrey, SM2 5PT, United Kingdom
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Contact
1-800-718-1021
[email protected]izer.com
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Advanced Non-Hematologic Malignancies
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

- Age greater than 18 years

- Documented advanced-stage non-hematologic malignancy for whom docetaxel monotherapy is a reasonable treatment option

- Eastern Cooperative Oncology Group [ECOG] performance status 0-1

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


- Significant active cardiac disease


- Chemotherapy, biological or investigational agents within 4 weeks prior to dosing


- Inadequate bone marrow, renal, cardiac or liver function

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Advanced Information
Descriptive Information
Brief Title  ICMJE CP-751,871 In Combination With Docetaxel In Advance Non-hematologic Malignancies
Official Title  ICMJE A Phase 1b Dose Escalation, Open-label Study Of CP-751,871 In Combination With Docetaxel In Advanced Non-hematologic Malignancies
Brief Summary This clinical trial is designed to determine the safety, tolerability, pharmacokinetics and pharmacodynamic effects of escalating doses of CP 751,871 given in combination with docetaxel in patients with non-hematologic malignancies for whom docetaxel is a reasonable treatment option.
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 Advanced Non-Hematologic Malignancies
Intervention  ICMJE
  • Drug: CP-751,871

    CP-751,871 was given intravenously [IV] every 3 weeks in escalating doses ranging from 0.1 mg/kg up to 20 mg/kg.

    Standard doses of Docetaxel were given every 3 weeks with CP-751,871. Study therapy was continued until disease progression, lack of tolerability for up to 17 cycles (approximately 1 year).

  • Drug: Docetaxel
    Docetaxel up to 75 mg/m^2 was administered intravenously [IV] on Day 1 of each 3-week dosing cycle.
Study Arms  ICMJE Experimental: CP-751,871 combined with docetaxel
Interventions:
  • Drug: CP-751,871
  • Drug: Docetaxel
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: July 27, 2012)		46
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2009
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age greater than 18 years
  • Documented advanced-stage non-hematologic malignancy for whom docetaxel monotherapy is a reasonable treatment option
  • Eastern Cooperative Oncology Group [ECOG] performance status 0-1

Exclusion Criteria:

  • Significant active cardiac disease
  • Chemotherapy, biological or investigational agents within 4 weeks prior to dosing
  • Inadequate bone marrow, renal, cardiac or liver function
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 Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01653158
Other Study ID Numbers  ICMJE A4021003
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 October 2013

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