A Safety Study Of A Monoclonal Antibody Against A5B1 Integrin In Solid Tumors
NCT00915278
ABOUT THIS STUDY
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- Histologically or cytologically confirmed advanced measurable or evaluable solid tumors unresponsive to currently available therapies, or for which there is no curative therapy
- Eastern Cooperative Oncology Group (ECOG) performance status 0 and 1
- Life expectancy more than12 weeks
- Adequate bone marrow, liver and renal function
- Known brain metastasis
- Chemotherapy, radiotherapy, or any investigational cancer therapy within 4 weeks of
start of screening procedures
- Major surgical procedure within 4 weeks of start of screening procedures
- Active bleeding disorder, including gastrointestinal bleeding, as evidenced by
hematemesis, significant hemoptysis or melena in the past 6 months
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Descriptive Information | ||||
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Brief Title ICMJE | A Safety Study Of A Monoclonal Antibody Against A5B1 Integrin In Solid Tumors | |||
Official Title ICMJE | A Phase 1 Safety, Pharmacokinetic And Pharmacodynamic Study Of The Anti-A5B1 Integrin Monoclonal Antibody PF-04605412 Administered Intravenously To Adult Patients With Advanced Or Metastatic Solid Tumors | |||
Brief Summary | Dose finding study of the MoaB PF-04605412 directed against the alpha5beta1 integrin. Main objective is to define the MTD (maximum tolerated dose) or MAD (maximum administrable dose) in cancer patients pre treated or unresponsive to standard therapies. | |||
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: PF-04605412
PF-04605412 will be administered as 2 hr IV infusion every 4 or 2 weeks. Start dose is 7.5 mg. Multiple doses are foreseen. Treatment will continue until intolerable toxicity, progression of disease or patient's refusal | |||
Study Arms ICMJE | Experimental: PF-04605412
Intervention: Drug: PF-04605412 | |||
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 | Terminated | |||
Actual Enrollment ICMJE | 33 | |||
Original Estimated Enrollment ICMJE | 60 | |||
Actual Study Completion Date ICMJE | January 2013 | |||
Actual Primary Completion Date | January 2013 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
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, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00915278 | |||
Other Study ID Numbers ICMJE | B1001001 | |||
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 |
| |||
PRS Account | Pfizer | |||
Verification Date | February 2014 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |