NCT01009190

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Feb 2010

Longer than P75 for phase_1

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 4, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 6, 2009

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2010

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

June 8, 2023

Status Verified

June 1, 2023

Enrollment Period

4.2 years

First QC Date

November 4, 2009

Last Update Submit

June 7, 2023

Conditions

Advanced Solid Tumors

Keywords

Dose finding PARPi Chemotherapy

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability of escalating doses of PF-01367338 in combination with chemotherapy (as defined by first-cycle DLTs)

    Dose-limiting toxicities and adverse events

    18 months

Secondary Outcomes (9)

  • Pharmacokinetics and pharmacodynamics of escalating doses of PF-01367338 in combination with several chemotherapeutic regimens

    18 months

  • Pharmacokinetics and pharmacodynamics of escalating doses of PF-01367338 in combination with several chemotherapeutic regimens

    18 months

  • Pharmacokinetics and pharmacodynamics of escalating doses of PF-01367338 in combination with several chemotherapeutic regimens

    18 months

  • Pharmacokinetics and pharmacodynamics of escalating doses of PF-01367338 in combination with several chemotherapeutic regimens

    18 months

  • Pharmacokinetics and pharmacodynamics of escalating doses of PF-01367338 in combination with several chemotherapeutic regimens

    18 months

  • +4 more secondary outcomes

Study Arms (2)

ARM A

EXPERIMENTAL

Carboplatin plus PF-01367338

Drug: PF-01367338Drug: Carboplatin

ARM A EXPANSION

EXPERIMENTAL

Carboplatin plus PF-01367338

Drug: PF-01367338Drug: Carboplatin

Interventions

PF-01367338DRUG

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

ARM A
CarboplatinDRUG

Standard doses of intravenous Carboplatin administered every 3 weeks

ARM A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with histologically confirmed solid tumors, Eastern Cooperative Oncology Group (ECOG) 0 or 1
  • Patients with acceptable renal, hepatic, and bone marrow function

You may not qualify if:

  • Symptomatic and/or unstable brain metastases,
  • Any cancer treatment within 4 weeks from study entry

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Churchill Hospital

Oxford, Oxfordshire, OX3 7LJ, United Kingdom

Location

Royal Marsden Hospital

Sutton, Surrey, SM2 5PT, United Kingdom

Location

Belfast City Hospital

Belfast, BT9 7AB, United Kingdom

Location

Beatson West of Scotland Cancer Centre

Glasgow, G12 0YN, United Kingdom

Location

Kings College London

London, SE1 9RT, United Kingdom

Location

Sir Bobby Robson Cancer Trials Research Centre

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

Related Publications (2)

  • 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.

    PMID: 35397664DERIVED

  • 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.

    PMID: 28222073DERIVED

MeSH Terms

Interventions

rucaparibCarboplatin

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2009

First Posted

November 6, 2009

Study Start

February 1, 2010

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

June 8, 2023

Record last verified: 2023-06

Locations

GB(6)