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Phase 1/2 Study Of PARP Inhibition With Olaparib To Enhance The Efficacy Of High-Dose Chemotherapy In Refractory And Relapsed Germ Cell Tumors

ConditionGerm Cell Cancer
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age12-60
SponsorM.D. Anderson Cancer Center

About this trial

The goal of this clinical research study is to find the highest safe dose of olaparib that can be combined with chemotherapy drugs and stem cell transplantation to treat patients with relapsed and refractory germ cell cancer. The safety and effectiveness of this treatment combination therapies will also be studied.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

12 - 60 years of age.

Extragonadal primary.

>2 prior relapses.

Unresponsive disease (PD or SD) to the immediately prior therapy.

Disqualifiers

Growing teratoma syndrome, defined as enlarging tumor masses with declining serum markers during chemotherapy for NSGCT.

Major surgery within 30 days before the initiation of study treatment.

Radiotherapy within 21 days prior to initiation of study treatment.

Patients with active CNS disease, defined as brain or meningeal metastases that are not in remission.

Trial design

Design model

Single group

Treatments tested in this trial

  • Olaparib

    Drug

    Given by mouth twice daily

  • Gemcitabine

    Drug

    Given by mouth twice daily

  • Docetaxel

    Drug

    Given by IV

  • Carboplatin

    Drug

    Given by IV

  • Etoposide

    Drug

    Given by IV

  • Autologous Stem-Cell Transplant (ASCT)

    Procedure/Surgery

    Given by IV

Treatment groups

36 Participants
are divided into 1 treatment group
Group A: Stage 1 Escalation and Stage 2 Expansion: Sequential Treatment with Olaparib/GemDC + Olaparib/CEExperimental treatment 6 interventions

Trial outcomes

Primary outcomes

1

Safety and Adverse Events (AEs)

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 6.0

Time frame
Through study completion; an average of 1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

M.D. Anderson Cancer Center

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: