Clinical trial · Interventional
A Study Of PF-03084014 In Japanese Patients With Advanced Solid Tumors
Phase 1 Study Of Pf-03084014 To Evaluate Safety And Pharmacokinetics In Japanese Patients With Advanced Solid Tumors
NCT02462707CI-TRIAL-00019383withdrawnPhase 1ClinicalTrials.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 determine the recommended Phase 2 dose for PF-03084014 single-agent administration in Japanese patients with advanced solid tumors. Pharmacokinetics and the overall safety profile of PF-03084014 will also be evaluated.
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-03084014 | Drug | Nirogacestat | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PF-03084014
- interventionNames
- Drug: PF-03084014
Primary outcomes (1)
- measure
- First-cycle Dose Limiting Toxicities
- timeFrame
- during the first 28 days from the first dose
Secondary outcomes (10)
- measure
- Maximum Observed Plasma Concentration (Cmax)
- timeFrame
- 0, 0.5, 1, 2, 4, 8, 24, 48, 96, 120 hours post-dose
- measure
- QTc interval
- timeFrame
- from the first dose to the last dose
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histological or cytological diagnosis of advanced solid tumors that is resistant to standard therapy or for which no standard therapy is available. * Age ≥18 years. * ECOG Performance Status (PS) must be 0 or 1. * Adequate Bone Marrow Function * Adequate Renal Function * Adequate Liver Function * Resolved acute effects of any prior therapy to baseline severity or Grade ≤1 Exclusion Criteria: * Patients with known brain metastases * Major surgery within 4 weeks of starting study treatment * Radiation therapy within 2 weeks of starting study treatment * Systemic anti cancer therapy within 2 weeks (4 weeks for antibody) of starting study treatment * Previous high dose chemotherapy requiring stem cell rescue * Prior irradiation to \>25% of the bone marrow * Prior treatment with a Notch signal inhibitor * Known malabsorption syndrome or other condition that may impair absorption of study medication * Any of the following in the previous 6 months: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism * Current use or anticipated need for known strong and/or moderate CYP3A4 inhibitors * Current use or anticipated need for known strong CYP3A4 inducers
References
Publications (0)
Data not yet available
No reference posted for this study.