A Dose Finding Study Of A New Medication, PF-00337210 That Will Possibly Decrease Blood Supply To Tumors
NCT01105533
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Adult Trials: 18+ Years
- Histologically or cytologically confirmed advanced solid tumors un-responsive to currently available therapies or for which there is no standard therapy.
- At least 1 measurable disease site as defined by Response Evaluation Criterion in Solid Tumors [RECIST].
- Adequate bone marrow, liver function and renal function as defined by protocol.
- Blood pressure Requirements During dose escalation - no evidence of pre-existing hypertension and no antihypertensive medications at baseline.
During dose expansion - patient's whose hypertension is controlled by antihypertensive therapy.
- Chemotherapy, radiotherapy or any investigational therapy within 4 weeks of study
entry
- Current use or anticipated need for drugs that are known CYP34 inhibitors or inducers.
- Patients with carcinomatous meningitis or un-treated brain metastases.
- Any acute cardiovascular incident within the past 12 months.
- Patients with active gastrointestinal bleeding or significant gastrointestinal
abnormalities as defined by protocol
- Patients with no evidence of the following for 5 years: malignancy or metastatic
disease of skin cancer (except melanoma), in situ cervical cancer or breast cancer or
T1C prostate cancer.
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | A Dose Finding Study Of A New Medication, PF-00337210 That Will Possibly Decrease Blood Supply To Tumors | |||
| Official Title ICMJE | Phase I, Open-Label, Multi-Center, Accelerated Dose Escalation Study Of The Anti-Angiogenesis Agent PF-00337210 In Patients With Advanced Solid Tumors | |||
| Brief Summary | This study will test a new cancer medication to determine if this medication will block blood supply to a tumor and decrease growth of a tumor. This study will also define the safety profile and define the safest dose of this new medication for people who have cancer. | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 1 | |||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
| Condition ICMJE | Neoplasm | |||
| Intervention ICMJE |
| |||
| Study Arms ICMJE |
| |||
| 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 | September 2011 | |||
| Actual Primary Completion Date | October 2010 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
During dose expansion - patient's whose hypertension is controlled by antihypertensive therapy. 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 States | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT01105533 | |||
| Other Study ID Numbers ICMJE | A8051001 | |||
| 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 | University of Wisconsin, Madison | |||
| Investigators ICMJE |
| |||
| PRS Account | Pfizer | |||
| Verification Date | February 2013 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||