A Study Of Poly (ADP-Ribose) Polymerase Inhibitor PF-01367338 In Combination With Several Chemotherapeutic Regimens
This study is currently recruiting participants.
Verified February 2013 by Clovis Oncology, Inc.
Sponsor:
Clovis Oncology, Inc.
Information provided by (Responsible Party):
Clovis Oncology, Inc.
ClinicalTrials.gov Identifier:
NCT01009190
First received: November 4, 2009
Last updated: February 19, 2013
Last verified: February 2013
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Purpose
Dose escalation phase 1 study of PARP inhibitor PF-01367338 in combination with chemotherapy in adult patients with advanced solid tumors
| Condition | Intervention | Phase |
|---|---|---|
|
Advanced Solid Tumors |
Drug: PF-01367338 Drug: Carboplatin |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Clovis Oncology, Inc.:
Primary Outcome Measures:
- Safety and tolerability of escalating doses of PF-01367338 in combination with chemotherapy (as defined by first-cycle DLTs) [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Pharmacokinetics and pharmacodynamics of escalating doses of PF-01367338 in combination with several chemotherapeutic regimens [ Time Frame: 18 months ] [ Designated as safety issue: No ]
- Determination of F constant for bioavailability of oral PF-01367338 compared to intravenous PF-01367338 [ Time Frame: 18 months ] [ Designated as safety issue: No ]
- Determination of food effect on oral PF-01367338 pharmacokinetics [ Time Frame: 18 month ] [ Designated as safety issue: No ]
- Determination of effect of PF-013567338 administration on QTc prolongation test [ Time Frame: 18 months ] [ Designated as safety issue: No ]
- Characterization of PF-01367338 metabolite profile [ Time Frame: 18 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | February 2010 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | November 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: ARM A
Carboplatin plus PF-01367338
|
Drug: PF-01367338
Increasing doses of single lead-in (Day -10) intravenous and daily oral PF-01367338 administered from Day 1 to Day 14 every 3-week cycle
Drug: Carboplatin
Standard doses of intravenous Carboplatin administered every 3 weeks
|
|
Experimental: ARM A EXPANSION
Carboplatin plus PF-01367338
|
Drug: PF-01367338
RP2 doses of oral PF-01367338 administered daily from Day 1 to Day 14 every 3-week cycle
Drug: Carboplatin
Standard doses of intravenous Carboplatin administered every 3 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01009190
Contacts
| Contact: Clovis Oncology Clinical Trial Information | clinicaltrialinfo@clovisoncology.com |
Locations
| France | |
| Centre Rene Gauducheau | Withdrawn |
| Nantes, France, 44805 | |
| Institut Gustave Roussy | Withdrawn |
| Villejuif, France, 94805 | |
| Italy | |
| Fondazione Centro San Raffaele del Monte Tabor | Withdrawn |
| Milano, Italy, 20132 | |
| United Kingdom | |
| Churchill Hospital | Recruiting |
| Oxford, Oxfordshire, United Kingdom, OX3 7LJ | |
| Royal Marsden Hospital | Recruiting |
| Sutton, Surrey, United Kingdom, SM2 5PT | |
| St. James's University Hospital | Withdrawn |
| Leeds, West Yorkshire, United Kingdom, LS9 7TF | |
| Belfast City Hospital | Recruiting |
| Belfast, United Kingdom, BT9 7AB | |
| Beatson West of Scotland Cancer Centre | Recruiting |
| Glasgow, United Kingdom, G12 0YN | |
| Kings College London | Recruiting |
| London, United Kingdom, SE1 9RT | |
| Sir Bobby Robson Cancer Trials Research Centre | Recruiting |
| Newcastle Upon Tyne, United Kingdom, NE7 7DN | |
Sponsors and Collaborators
Clovis Oncology, Inc.
More Information
No publications provided
| Responsible Party: | Clovis Oncology, Inc. |
| ClinicalTrials.gov Identifier: | NCT01009190 History of Changes |
| Other Study ID Numbers: | CO-338-1014 |
| Study First Received: | November 4, 2009 |
| Last Updated: | February 19, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Clovis Oncology, Inc.:
|
Dose finding PARPi Chemotherapy |
Additional relevant MeSH terms:
|
Antineoplastic Agents Carboplatin Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013