Clinical trial · Interventional
PF-00477736 Is Being Studied In Advanced Solid Tumors In Combination With Chemotherapy With Gemcitabine
Phase I Study of PF-00477736 With Gemcitabine In Patients With Advanced Solid Malignancies
NCT00437203CI-TRIAL-00006649terminatedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): See termination reason in detailed description.
Summary
Brief summary (as posted)
To determine the overall safety of PF-00477736 when given in combination with gemcitabine, a chemotherapy agent, in patients with advanced solid tumors and determine the maximum dose of PF-00477736 that can be safely given in combination with gemcitabine. This is the first study of PF-00477736 in humans.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gemcitabine | Drug | Gemcitabine | ALIAS |
| PF-00477736 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Drug: PF-00477736
- Drug: gemcitabine
Primary outcomes (1)
- measure
- Maximum Tolerated Dose (MTD) of PF-00477736 When Administered in Combination With Gemcitabine
- timeFrame
- Up to Day 21 Cycle 1
Secondary outcomes (10)
- measure
- Number of Participants With Objective Response (OR)
- timeFrame
- Baseline, Day 15 of Cycle 2 and 4 and every 4 cycles thereafter up to Week 62
- description
- OR based assessment of confirmed complete response(CR)/confirmed partial response(PR)/stable disease(SD)/progressive disease(PD) as per Response Evaluation Criteria in Solid Tumors(RECIST).CR:disappearance of target lesions;PR:at least(\>=) 30% decrease in sum of longest dimensions of target lesions(reference:baseline sum of longest dimensions);PD:\>=20% increase in sum of longest dimensions of target lesions(reference:smallest sum of longest dimensions recorded since treatment started)/appearance of any new lesions;SD:no adequate shrinkage to qualify for PR/adequate increase to qualify for PD.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histological or cytopathological diagnosis of solid malignancy that is refractory to standard therapy or for which no curative therapy exists. * ECOG performance status 0 or 1. * Adequate blood cell counts, kidney function and liver function. Exclusion Criteria: * Prior treatment with gemcitabine. * Uncontrolled brain metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal disease. * NCI CTC Grade 2 or higher ARDS, non-infectious pneumonitis, or pulmonary fibrosis. * NCI CTC Grade 2 or higher cardiovascular toxicities with the exception of NCI CTC Grade 3 hypertension that is well controlled. * Known human immunodeficiency virus (HIV) seropositivity. * Concurrent treatment with anticoagulants or known coagulopathy
References
Publications (0)
Data not yet available
No reference posted for this study.