Clinical trial · Interventional
A First In Patient, Study Of Investigational Drug PF-03446962 In Patients With Advanced Solid Tumors
A Phase 1 Pharmacokinetic And Pharmacodynamic Study Of Pf-03446962 In Patients With Advanced Solid Tumors
NCT00557856CI-TRIAL-00019507completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PF-03446962 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Drug: PF-03446962
Primary outcomes (2)
- measure
- Maximum Tolerated Dose (MTD): Part 1
- timeFrame
- Baseline up to 42 days after the start of each increased treatment dose
- description
- MTD was defined as highest dose level for which no more than 1 participant in a dose cohort experienced DLT and at least 2 out of 3/6 participants in the next higher dose. DLT was defined as any of the following events occurring during the first 42 days of study drug: any grade greater than or equal to 3 hematologic and non-hematologic toxicity, all non-disease-related adverse events (AEs).
- measure
- Recommended Phase 2 Dose (RP2D): Part 1
- timeFrame
- Baseline up to 42 days after the start of each increased treatment dose
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDSimonelli M, Zucali P, Santoro A, Thomas MB, de Braud FG, Borghaei H, Berlin J, Denlinger CS, Noberasco C, Rimassa L, Kim TY, English PA, Abbattista A, Gallo Stampino C, Carpentieri M, Williams JA. Phase I study of PF-03446962, a fully human monoclonal antibody against activin receptor-like kinase-1, in patients with hepatocellular carcinoma. Ann Oncol. 2016 Sep;27(9):1782-7. doi: 10.1093/annonc/mdw240. Epub 2016 Jun 20. PMID 27329247
- DERIVEDGoff LW, Cohen RB, Berlin JD, de Braud FG, Lyshchik A, Noberasco C, Bertolini F, Carpentieri M, Stampino CG, Abbattista A, Wang E, Borghaei H. A Phase I Study of the Anti-Activin Receptor-Like Kinase 1 (ALK-1) Monoclonal Antibody PF-03446962 in Patients with Advanced Solid Tumors. Clin Cancer Res. 2016 May 1;22(9):2146-54. doi: 10.1158/1078-0432.CCR-15-1622. Epub 2015 Dec 11. PMID 26655846