Clinical trial · Interventional
Asian Phase I Study Of PF-03446962
A Phase I Pharmacokinetic And Pharmacodynamic Study Of Pf-03446962 In Asian Patient With Advanced Solid Tumors
NCT01337050CI-TRIAL-00019606completedPhase 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 is an Asian Phase 1, multi center, open label, single arm study of PF 03446962 with dose escalation and designed to define the Maximum Tolerated Dose \[MTD\] and the Recommended Phase 2 Dose \[RP2D\].
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 |
|---|---|---|---|
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PF-03446962 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- A
- description
- PF-03446962
- interventionNames
- Drug: PF-03446962
Primary outcomes (2)
- measure
- Maximum Tolerated Dose (MTD)
- timeFrame
- Baseline up to Week 6
- description
- The MTD was defined as the highest dose of PF-03446962 associated with the occurrence of Dose Limiting Toxicities (DLTs) in at most 1 of 6 participants with the next higher dose having at least 2/3 or 2/6 participants experiencing DLTs (that is (i.e.) Maximum Administrated Dose). DLT is defined if the participants meets the following criteria during the first 6 weeks of treatment, possibly attributable to PF-03446962. Neutropenia grade 4 (less than \[\< \])500/cubic millimeter \[mm\^ 3\]) lasting for greater than equal to (\>=) 8 days; Febrile Neutropenia \>= Grade 3; Neutropenic Infection \>= Grade 3; Grade 4 thrombocytopenia (\<25,000/mm\^3); Grade 3 thrombocytopenia (\<50,000/mm\^3) with active bleeding; Grade 3 or higher non-hematological toxicity.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Confirmed diagnosis of stomach cancer * advanced/metastasis solid tumor refractory or intolerant to established therapy * adequate blood chemistry, blood counts and kidney/liver function * willing to participate to study requirements and sign an informed consent document Exclusion Criteria: * Chemotherapy, radiotherapy, or any investigational cancer therapy within 4 weeks of first dose of study medication * excessive toxicities related to prior therapies * pregnant or breastfeeding patients
References
Publications (0)
Data not yet available
No reference posted for this study.