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

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NCT01653158

Last updated on May 9, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Sutton, Surrey, SM2 5PT United Kingdom
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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

NCT01653158
Pfizer
Completed
CP-751,871 In Combination With Docetaxel In Advance Non-hematologic Malignancies

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CP-751,871 In Combination With Docetaxel In Advance Non-hematologic Malignancies
A Phase 1b Dose Escalation, Open-label Study Of CP-751,871 In Combination With Docetaxel In Advanced Non-hematologic Malignancies
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.
Not Provided
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Advanced Non-Hematologic Malignancies
  • 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.
Experimental: CP-751,871 combined with docetaxel
Interventions:
  • Drug: CP-751,871
  • Drug: Docetaxel
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
46
February 2009
February 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT01653158
A4021003
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2013

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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