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

June 7, 2023 updated by: zr Pharma & GmbH

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

85

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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
Drug: PF-01367338
RP2 doses of oral PF-01367338 administered daily from Day 1 to Day 14 every 3-week cycle
Experimental: ARM A EXPANSION
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
Drug: PF-01367338
RP2 doses of oral PF-01367338 administered daily from Day 1 to Day 14 every 3-week cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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]
18 months
Pharmacokinetics and pharmacodynamics of escalating doses of PF-01367338 in combination with several chemotherapeutic regimens
Time Frame: 18 months
maximum plasma concentration (CMax)
18 months
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)
18 months
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)
18 months
Pharmacokinetics and pharmacodynamics of escalating doses of PF-01367338 in combination with several chemotherapeutic regimens
Time Frame: 18 months
rucaparib oral bioavailability
18 months
PARP activity and expression in peripheral blood lymphocytes (PBL)
Time Frame: 18 months
% PARP activity
18 months
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]
18 month
Determination of food effect on oral PF-01367338 pharmacokinetics
Time Frame: 18 month
fasted and fed maximum plasma concentration (Cmax)
18 month
Determination of effect of PF-013567338 administration on QTc prolongation test
Time Frame: 18 months
electrocardiogram[ecg], QTcF, QTcB
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

zr Pharma & GmbH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

November 4, 2009

First Submitted That Met QC Criteria

November 5, 2009

First Posted (Estimated)

November 6, 2009

Study Record Updates

Last Update Posted (Actual)

June 8, 2023

Last Update Submitted That Met QC Criteria

June 7, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CO-338-1014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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