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A Study Of Poly (ADP-Ribose) Polymerase Inhibitor PF-01367338 In Combination With Several Chemotherapeutic Regimens

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ClinicalTrials.gov Identifier: NCT01009190
Recruitment Status : Completed
First Posted : November 6, 2009
Last Update Posted : August 8, 2017
Sponsor:
Information provided by (Responsible Party):
Clovis Oncology, Inc.

Brief Summary:
Dose escalation phase 1 study of PARP inhibitor PF-01367338 in combination with chemotherapy in adult patients with advanced solid tumors

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Drug: PF-01367338 Drug: Carboplatin Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 85 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : February 2010
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Safety and tolerability of escalating doses of PF-01367338 in combination with chemotherapy (as defined by first-cycle DLTs) [ Time Frame: 18 months ]
    Dose-limiting toxicities and adverse events


Secondary Outcome Measures :
  1. Pharmacokinetics and pharmacodynamics of escalating doses of PF-01367338 in combination with several chemotherapeutic regimens [ Time Frame: 18 months ]
    Time to attain maximum plasma concentration [Tmax]

  2. Pharmacokinetics and pharmacodynamics of escalating doses of PF-01367338 in combination with several chemotherapeutic regimens [ Time Frame: 18 months ]
    maximum plasma concentration (CMax)

  3. Pharmacokinetics and pharmacodynamics of escalating doses of PF-01367338 in combination with several chemotherapeutic regimens [ Time Frame: 18 months ]
    area under plasma concentration curve (AUC)

  4. Pharmacokinetics and pharmacodynamics of escalating doses of PF-01367338 in combination with several chemotherapeutic regimens [ Time Frame: 18 months ]
    apparent terminal half-life (t1/2)

  5. Pharmacokinetics and pharmacodynamics of escalating doses of PF-01367338 in combination with several chemotherapeutic regimens [ Time Frame: 18 months ]
    rucaparib oral bioavailability

  6. PARP activity and expression in peripheral blood lymphocytes (PBL) [ Time Frame: 18 months ]
    % PARP activity

  7. Determination of food effect on oral PF-01367338 pharmacokinetics [ Time Frame: 18 month ]
    fasted and fed parameters area under the plasma concentration-time curve from time 0 to the last recorded observation [AUClast]

  8. Determination of food effect on oral PF-01367338 pharmacokinetics [ Time Frame: 18 month ]
    fasted and fed maximum plasma concentration (Cmax)

  9. Determination of effect of PF-013567338 administration on QTc prolongation test [ Time Frame: 18 months ]
    electrocardiogram[ecg], QTcF, QTcB



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01009190


Locations
United Kingdom
Churchill Hospital
Oxford, Oxfordshire, United Kingdom, OX3 7LJ
Royal Marsden Hospital
Sutton, Surrey, United Kingdom, SM2 5PT
Belfast City Hospital
Belfast, United Kingdom, BT9 7AB
Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom, G12 0YN
Kings College London
London, United Kingdom, SE1 9RT
Sir Bobby Robson Cancer Trials Research Centre
Newcastle Upon Tyne, United Kingdom, NE7 7DN
Sponsors and Collaborators
Clovis Oncology, Inc.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Clovis Oncology, Inc.
ClinicalTrials.gov Identifier: NCT01009190     History of Changes
Other Study ID Numbers: CO-338-1014
First Posted: November 6, 2009    Key Record Dates
Last Update Posted: August 8, 2017
Last Verified: July 2015

Keywords provided by Clovis Oncology, Inc.:
Dose finding PARPi Chemotherapy

Additional relevant MeSH terms:
Rucaparib
Carboplatin
Poly(ADP-ribose) Polymerase Inhibitors
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action