Clinical trial · Interventional
A Study Of Poly (ADP-Ribose) Polymerase Inhibitor PF-01367338 In Combination With Several Chemotherapeutic Regimens
A Parallel Arms Phase 1 Safety, Pharmacokinetic And Pharmacodynamic Study Of The Intravenous Poly (ADP-Ribose) Polymerase (PARP) Inhibitor PF-01367338 (AG-014699) In Combination With Several Chemotherapeutic Regimens In Adult Patients With Advanced Solid Tumor
NCT01009190CI-TRIAL-00067019completedPhase 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)
Dose escalation phase 1 study of PARP inhibitor PF-01367338 in combination with chemotherapy in adult patients with advanced 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 |
|---|---|---|---|
| Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| PF-01367338 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ARM A
- description
- Carboplatin plus PF-01367338
- interventionNames
- Drug: PF-01367338
- Drug: Carboplatin
- type
- EXPERIMENTAL
- label
- ARM A EXPANSION
- description
- Carboplatin plus PF-01367338
- interventionNames
- Drug: PF-01367338
- Drug: Carboplatin
Primary outcomes (1)
- measure
- Safety and tolerability of escalating doses of PF-01367338 in combination with chemotherapy (as defined by first-cycle DLTs)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with histologically confirmed solid tumors, Eastern Cooperative Oncology Group (ECOG) 0 or 1 * Patients with acceptable renal, hepatic, and bone marrow function Exclusion Criteria: * Symptomatic and/or unstable brain metastases, * Any cancer treatment within 4 weeks from study entry
References
Publications (2)
- DERIVEDGreen ML, Ma SC, Goble S, Giordano H, Maloney L, Simmons AD, Beltman J, Harding TC, Xiao JJ. Population pharmacokinetics of rucaparib in patients with advanced ovarian cancer or other solid tumors. Cancer Chemother Pharmacol. 2022 May;89(5):671-682. doi: 10.1007/s00280-022-04413-7. Epub 2022 Apr 10. PMID 35397664
- DERIVEDWilson RH, Evans TJ, Middleton MR, Molife LR, Spicer J, Dieras V, Roxburgh P, Giordano H, Jaw-Tsai S, Goble S, Plummer R. A phase I study of intravenous and oral rucaparib in combination with chemotherapy in patients with advanced solid tumours. Br J Cancer. 2017 Mar 28;116(7):884-892. doi: 10.1038/bjc.2017.36. Epub 2017 Feb 21. PMID 28222073