Phase 1/2 Study Of PARP Inhibition With Olaparib To Enhance The Efficacy Of High-Dose Chemotherapy In Refractory And Relapsed Germ Cell Tumors
2 other identifiers
interventional
36
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Mar 2027
Longer than P75 for phase_1
1 active site
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
September 28, 2026
CompletedFirst Posted
Study publicly available on registry
October 1, 2026
CompletedStudy Start
First participant enrolled
March 1, 2027
ExpectedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2029
Study Completion
Last participant's last visit for all outcomes
December 31, 2031
October 1, 2026
September 1, 2026
2.8 years
September 28, 2026
September 28, 2026
Conditions
Outcome Measures
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
Through study completion; an average of 1 year
Study Arms (1)
Stage 1 Escalation and Stage 2 Expansion: Sequential Treatment with Olaparib/GemDC + Olaparib/CE
EXPERIMENTALTreatment will be administered on an inpatient basis.
Interventions
Given by mouth twice daily
Given by mouth twice daily
Given by IV
Given by IV
Given by IV
Given by IV
Eligibility Criteria
You may qualify if:
- years of age.
- Diagnosis of relapsed GCT, with one or more of the following criteria:
- Extragonadal primary.
- \>2 prior relapses.
- Unresponsive disease (PD or SD) to the immediately prior therapy.
- ECOG PS ≤ 2 (Karnofsky ≥ 60%).in adults, Lansky Play-Performance Scale (LPPS) ≥ 60% in pediatric patients.
- A minimum apheresis collection of 5 million CD34+ cells/kg of autologous peripheral blood progenitor cells (PBPC).
- Adequate blood counts (WBC ≥ 2K, HGB ≥ 8 g/dL, platelets ≥ 50K).
- Creatinine clearance ≥ 50 ml/min/1.73 m2 (estimated by the Cockroft-Gault method in adults and the Schwartz formula in pediatric patients) and/or serum creatinine ≤ 1.8 mg/dL.
- ALT and/or AST ≤ 3 x institutional ULN, and bilirubin and alkaline phosphatase (ALP) ≤ 2 x institutional ULN.
- FE 1, F and DL Oc ≥ 0%
- L EF ≥ 0%, without active arrythmias
- If female of child-bearing potential, she must not be pregnant or breastfeeding and required to have a negative urine or serum pregnancy test prior to enrollment.
- For patients at risk for hepatitis B (HBV) reactivation (HBsAg+/negative HBV viremia, or HBsAg-/anti-HBc+) will be eligible as long as they are on suppressive antiviral therapy.
- Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection still on treatment, they are eligible if they have an undetectable HCV viral load.
- +11 more criteria
You may not qualify if:
- 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.
- Patients with active hepatitis B, either active carrier (HBsAg+ and not on suppressive antivirals) or viremic (HBV DNA ≥10,000 copies/mL, or ≥ 2,000 IU/mL) or hepatitis C (detectable viral load by HCV RNA PCR).
- Evidence of either cirrhosis or stage 3-4 liver fibrosis in patients who either show chronic hepatitis C or positive hepatitis C serology.
- Active infection requiring parenteral antibiotics.
- HIV infection, unless the patient is receiving effective antiretroviral therapy with undetectable viral load and CD4+ ≥ 350 cells/uL.
- Patients who have had a previous autologous or allogeneic stem cell transplant in the previous 12 months.
- Grade =≥ 3 non-hematologic toxicity from prior therapy not improved to grade ≤ 2.
- Active infection requiring parenteral antibiotics.
- Treatment within prior 2 weeks with any anti-cancer agent, investigational or approved.
- Patients with psychiatric illness/social situations that would limit compliance with study requirements.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to olaparib, gemcitabine, docetaxel, carboplatin, or etoposide or other agents used in study.
- Patients with uncontrolled intercurrent neurological illness.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UT MD Anderson
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yago Nieto, MD, PHD
UT MD Anderson
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 28, 2026
First Posted
October 1, 2026
Study Start (Estimated)
March 1, 2027
Primary Completion (Estimated)
December 31, 2029
Study Completion (Estimated)
December 31, 2031
Last Updated
October 1, 2026
Record last verified: 2026-09