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Olaparib + Chemotherapy for Testicular Cancer

YN
Overseen ByYago Nieto, MD, PHD
Age: < 65
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: M.D. Anderson Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of 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.

Who Is on the Research Team?

YN

Yago Nieto, MD, PHD

Principal Investigator

UT MD Anderson

Are You a Good Fit for This Trial?

This trial is for people with germ cell tumors, including testicular cancer, whose disease has come back or not responded to previous treatments. Participants should be healthy enough for high-dose chemotherapy and stem cell transplant.

Inclusion Criteria

Minimum apheresis collection of 5 million CD34+ cells/kg of autologous peripheral blood progenitor cells
My heart pumps normally and I do not have irregular heartbeats.
Creatinine clearance ≥ 50 ml/min/1.73 m2 or serum creatinine ≤ 1.8 mg/dL
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Exclusion Criteria

I currently have an infection needing IV antibiotics.
I have an active hepatitis B or C infection.
I have had radiation therapy within the last 21 days.
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What Are the Treatments Tested in This Trial?

Interventions

  • Autologous Stem-Cell Transplant (ASCT)
  • Carboplatin
  • Docetaxel
  • Etoposide
  • Gemcitabine
  • Olaparib

Trial Overview

Researchers are testing the safety and effectiveness of adding olaparib (a PARP inhibitor) to a combination of strong chemotherapy drugs followed by an autologous stem-cell transplant in patients with hard-to-treat germ cell tumors.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Stage 1 Escalation and Stage 2 Expansion: Sequential Treatment with Olaparib/GemDC + Olaparib/CEExperimental Treatment6 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+

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