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

NCT ID: NCT01009190

Last Updated: 2023-06-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2014-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Advanced Solid Tumors

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ARM A

Carboplatin plus PF-01367338

Group Type EXPERIMENTAL

PF-01367338

Intervention Type DRUG

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

Carboplatin

Intervention Type DRUG

Standard doses of intravenous Carboplatin administered every 3 weeks

ARM A EXPANSION

Carboplatin plus PF-01367338

Group Type EXPERIMENTAL

PF-01367338

Intervention Type DRUG

RP2 doses of oral PF-01367338 administered daily from Day 1 to Day 14 every 3-week cycle

Carboplatin

Intervention Type DRUG

Standard doses of intravenous Carboplatin administered every 3 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DRUG

Carboplatin

Standard doses of intravenous Carboplatin administered every 3 weeks

Intervention Type DRUG

PF-01367338

RP2 doses of oral PF-01367338 administered daily from Day 1 to Day 14 every 3-week cycle

Intervention Type DRUG

Carboplatin

Standard doses of intravenous Carboplatin administered every 3 weeks

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

pharmaand GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Churchill Hospital

Oxford, Oxfordshire, United Kingdom

Site Status

Royal Marsden Hospital

Sutton, Surrey, United Kingdom

Site Status

Belfast City Hospital

Belfast, , United Kingdom

Site Status

Beatson West of Scotland Cancer Centre

Glasgow, , United Kingdom

Site Status

Kings College London

London, , United Kingdom

Site Status

Sir Bobby Robson Cancer Trials Research Centre

Newcastle upon Tyne, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

References

Explore related publications, articles, or registry entries linked to this study.

Green 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.

Reference Type DERIVED
PMID: 35397664 (View on PubMed)

Wilson 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.

Reference Type DERIVED
PMID: 28222073 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CO-338-1014

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Safety Study of FP-1039 To Treat Cancer
NCT00687505 COMPLETED PHASE1
SMP-3124LP in Adults With Advanced Solid Tumors
NCT06526819 RECRUITING PHASE1/PHASE2