Phase 1
Completed N=46
A First In Patient, Study Of Investigational Drug PF-03446962 In Patients With Advanced Solid Tumors
Source: ClinicalTrials.gov NCT00557856 ↗Enrolled (actual)
46
Serious AEs
35.3%
Results posted
Aug 2015
Primary outcomePrimary: Maximum Tolerated Dose (MTD): Part 1 — 10.0 milligram/kilogram (mg/kg)
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Tolerated Dose (MTD): Part 1 |
10.0 | — |
| PRIMARY Recommended Phase 2 Dose (RP2D): Part 1 |
7.0 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (AEs): Part 1 and Part 2 |
5; 5; 6; 3; 4; 8 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (AEs) Based on Severity: Part 1 and Part 2 |
3; 2; 1; 1; 0; 0 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (AEs) Based on Seriousness: Part 1 and Part 2 |
5; 5; 6; 3; 4; 8 | — |
| SECONDARY Time to Treatment-Emergent Adverse Events (AEs): Part 1 and Part 2 |
— | — |
| SECONDARY Number of Participants With Laboratory Abnormalities: Part 1 and Part 2 |
4; 4; 5; 1; 3; 5 | — |
| SECONDARY Percentage of Participants With Objective Response: Part 1 and Part 2 |
0; 0; 16.7; 0; 0; 0 | — |
| SECONDARY Percentage of Participants With Disease Control: Part 2 |
29.2 | — |
| SECONDARY Time To Progression (TTP): Part 2 |
3.0 | — |
| SECONDARY Volume of Distribution: Part 1 and Part 2 |
6.350; 5.770; 7.421; NA; NA; 6.718 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00557856). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.