A First In Patient, Study Of Investigational Drug PF-03446962 In Patients With Advanced Solid Tumors
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00557856
First received: November 12, 2007
Last updated: May 22, 2013
Last verified: May 2013
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Purpose
The purpose of this study is to test the safety and effectiveness of PF-03446962 when given as a single agent. Tumors require new blood vessels to support their ability to grow and to spread (metastasize). New treatments aimed at preventing these blood vessels have the ability to improve the clinical management of cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Advanced Solid Tumors |
Drug: PF-03446962 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 1 Pharmacokinetic And Pharmacodynamic Study Of PF-03446962 In Patients With Advanced Solid Tumors |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- To determine the maximum tolerated dose (MTD), and recommended Phase 2 dose (RP2D) of PF-03446962 administered in patients with advanced solid tumors. [ Time Frame: 1.5 years ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Single dose and multi dose PK [ Time Frame: 1.5 years ] [ Designated as safety issue: Yes ]
- Evaluation of immunogenicity [ Time Frame: 1.5 years ] [ Designated as safety issue: Yes ]
- To document any preliminary evidence of antitumor activity [ Time Frame: 1.5 years ] [ Designated as safety issue: Yes ]
- To assess the effect on vascular function adopting DCE MRI [ Time Frame: 1.5 years ] [ Designated as safety issue: Yes ]
- To measure circulating endothelial cells (CEC), circulating endothelial progenitors (CEP) along with soluble proteins related to ALK 1 signaling [ Time Frame: 1.5 years ] [ Designated as safety issue: Yes ]
- To establish the safety profile of PF-03446962 administered IV as single agent. [ Time Frame: 1.5 years ] [ Designated as safety issue: Yes ]
| Enrollment: | 68 |
| Study Start Date: | November 2007 |
| Study Completion Date: | April 2013 |
| Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: PF-03446962
To determine the maximum tolerated dose (MTD), and recommended Phase 2 dose (RP2D) of PF-03446962 administered in patients with advanced solid tumors.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Advanced measurable or non-measurable solid tumors
- Adequate bone marrow function
- Adequate liver function
- Adequate renal function
- Be able and willing to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures
Exclusion Criteria:
- Chemotherapy, radiotherapy, or any investigational cancer therapy within 4 weeks of first dose of study medication
- Active bleeding disorder, including gastrointestinal bleeding, as evidenced by hematemesis, hemoptysis or melena in the past 6 months
- Any of the following within the 12 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, cerebrovascular accident including transient ischemic attack, or pulmonary embolus; or any other active thromboembolic event
- QTc prolongation defined as QTc >450 msec
- Patients with known brain metastasis
- Patients with peritoneal carcinosis at risk of bleeding
- Major surgical procedure within 4 weeks of treatment
- Pregnancy or breastfeeding
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00557856
Locations
| United States, Pennsylvania | |
| Pfizer Investigational Site | |
| Philadelphia, Pennsylvania, United States, 19111 | |
| United States, South Carolina | |
| Pfizer Investigational Site | |
| Charleston, South Carolina, United States, 29425 | |
| United States, Tennessee | |
| Pfizer Investigational Site | |
| Nashville, Tennessee, United States, 37232 | |
| Italy | |
| Pfizer Investigational Site | |
| Milano, Italy, 20141 | |
| Pfizer Investigational Site | |
| Milano, Italy, 20132 | |
| Pfizer Investigational Site | |
| Rozzano (MI), Italy, 20089 | |
| Korea, Republic of | |
| Pfizer Investigational Site | |
| Seoul, Korea, Republic of, 110-744 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00557856 History of Changes |
| Other Study ID Numbers: | A8471001 |
| Study First Received: | November 12, 2007 |
| Last Updated: | May 22, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
Solid Tumors Transforming Growth Factor Beta Activin Receptor-like Kinase 1 |
Additional relevant MeSH terms:
|
Neoplasms |
ClinicalTrials.gov processed this record on June 17, 2013