Clinical trial · Interventional
A Study Of PF-04554878 In Patients With Advanced Non-Hematologic Malignancies
A Phase 1, Open-Label, Dose Escalation Study To Evaluate Safety, Pharmacokinetics And Pharmacodynamics Of PF-04554878 In Patients With Advanced Non-Hematologic Malignancies
- 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)
Phase 1 safety, pharmacokinetics, and pharmacodynamics trial of the focal adhesion kinase (FAK) inhibitor PF-04554878 in patients with advanced non-hematologic malignancies, including patients with malignancies appropriate for serial biopsy. Screening consists of medical history, physical examination ECOG performance status, blood draws, a pregnancy test for female patients of childbearing potential, a FDG-PET and tumor imaging. Treatment consists of PF-04554878 pills continued until progression of disease, unacceptable toxicity, or patient request. Evaluations for bioactivity are measured by serial FDG-PET and blood tests for biomarkers related to FAK and Pyk2 activities.
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 |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PF-04554878 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- Dose escalation study with Expansion Cohorts at RP2D and Schedule
- interventionNames
- Drug: PF-04554878
Primary outcomes (2)
- measure
- Recommended Phase 2 Dose
- timeFrame
- 18 months
- measure
- Overall safety profile of PF-04554878, including Dose-Limiting Toxicity (DLT)
- timeFrame
- 18 months
Secondary outcomes (4)
- measure
- Tumor metabolic response
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with advanced non-hematologic malignancies. * Adequate organ function, including bilirubin less than 1.5 x ULN, and ECOG (Eastern Cooperative Oncology Group) performance status of 0-2. Exclusion Criteria: * Clinically significant gastrointestinal abnormalities, requirement for systemic anticoagulants or potent CYP 2C8 inhibitors, and history of clinically significant cardiac or pulmonary disorders
References
Publications (1)
- DERIVEDJones SF, Siu LL, Bendell JC, Cleary JM, Razak AR, Infante JR, Pandya SS, Bedard PL, Pierce KJ, Houk B, Roberts WG, Shreeve SM, Shapiro GI. A phase I study of VS-6063, a second-generation focal adhesion kinase inhibitor, in patients with advanced solid tumors. Invest New Drugs. 2015 Oct;33(5):1100-7. doi: 10.1007/s10637-015-0282-y. Epub 2015 Sep 4. PMID 26334219