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Completed

NCT Number: NCT01009190

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

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

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Key information

Conditions

Advanced Solid Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Churchill Hospital, Oxford, Oxfordshire, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PF-01367338

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

Drug

Standard doses of intravenous Carboplatin administered every 3 weeks

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

pharmaand GmbH

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Nov 6, 2009
Registry last updated
Jun 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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