Clinical trial · Interventional
A Study Of PF-04449913 Administered Alone In Select Solid Tumors
A PHASE 1 STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF PF 04449913, AN ORAL HEDGEHOG INHIBITOR, ADMINISTERED AS SINGLE AGENT IN SELECT SOLID TUMORS
NCT01286467CI-TRIAL-00074718completedPhase 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)
This study examines the effect of a small molecule inhibitor to the Sonic Hedgehog pathway on select solid tumors.
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 |
|---|---|---|---|
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PF-04449913 | Drug | Glasdegib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Drug: PF-04449913
Primary outcomes (1)
- measure
- Number of Participants With First Cycle Dose Limiting Toxicities (DLTs)
- timeFrame
- Baseline up to end of Cycle 1 (Study Day 28)
- description
- Any DLT event in Cycle 1: (1) Grade 4 neutropenia lasting more than 7 days; (2) Febrile neutropenia; (3) Grade \>=3 neutropenic infection; (4) Grade \>=3 thrombocytopenia with bleeding; (5) Grade 4 thrombocytopenia lasting more than 7 days; (6) Grade \>=3 non-hematologic toxicity; (7) Failure to deliver at least 80% of the planned doses due to toxicities attributable to PF-04449913
Secondary outcomes (21)
- measure
- Percentage of Participants With Treatment-emergent Adverse Events (AEs), by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (Version 4.0) Grade
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * Histological or cytological diagnosis of advanced/metastatic solid tumor * Adequate Bone Marrow Function * Adequate Renal Function * Adequate Liver Function Exclusion Criteria: * Patients with known symptomatic brain metastases requiring steroids * Current active treatment on another clinical trial * Major surgery or radiation therapy within 4-weeks of starting study treatment
References
Publications (2)
- DERIVEDFostvedt LK, Shaik N, Martinelli G, Wagner AJ, Ruiz-Garcia A. Exposure-response modeling of the effect of glasdegib on cardiac repolarization in patients with cancer. Expert Rev Clin Pharmacol. 2021 Jul;14(7):927-935. doi: 10.1080/17512433.2021.1925538. Epub 2021 May 18. PMID 33993815
- DERIVEDWagner AJ, Messersmith WA, Shaik MN, Li S, Zheng X, McLachlan KR, Cesari R, Courtney R, Levin WJ, El-Khoueiry AB. A phase I study of PF-04449913, an oral hedgehog inhibitor, in patients with advanced solid tumors. Clin Cancer Res. 2015 Mar 1;21(5):1044-51. doi: 10.1158/1078-0432.CCR-14-1116. Epub 2014 Nov 11. PMID 25388167