CP-751,871 In Combination With Docetaxel In Advance Non-hematologic Malignancies
NCT01653158
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- 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
- 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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Descriptive Information | ||||
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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 |
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Study Arms ICMJE | Experimental: CP-751,871 combined with docetaxel
Interventions:
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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 | 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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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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 |