Actively Recruiting
Maintenance Zanzalintinib With Etoposide After HDCT in GCT
Led by Indiana University · Updated on 2025-11-21
38
Participants Needed
1
Research Sites
302 weeks
Total Duration
On this page
Sponsors
I
Indiana University
Lead Sponsor
E
Exelixis
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is an open label, single arm phase I/II trial of maintenance zanzalintinib in combination with oral etoposide in patients with relapsed GCT treated with HDCT and PBSCT with a safety lead-in cohort in patients with relapsed, refractory metastatic GCT.
CONDITIONS
Official Title
Maintenance Zanzalintinib With Etoposide After HDCT in GCT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Histological or serological evidence of incurable, refractory, or relapsed metastatic germ cell tumor, including seminoma, non-seminoma, and ovarian GCTs
- Previous treatment with cisplatin-based chemotherapy and at least one salvage regimen with progression or failure
- Relapsed primary mediastinal non-seminomatous GCT or late relapse (>2 years) not suitable for surgery
- For phase II, completed salvage treatment with HDCT and PBSCT for 2 tandem cycles per guidelines
- HDCT used as initial salvage chemotherapy regimen (2nd line therapy); prior 1 or 2 cycles of standard regimens acceptable
- Normal or declining tumor markers (AFP and hCG) and considered disease free at screening
- Last dose of HDCT within 16 weeks before study registration
- Written informed consent and HIPAA authorization
- ECOG performance status 0-2 within 28 days prior to registration
- Recovery from prior therapy adverse events to grade ≤ 2 unless stable on supportive therapy
- Adequate laboratory values within 14 days prior to registration including hemoglobin ≥ 9 g/dL, WBC ≥ 2500/µL, ANC ≥ 1500/mm3, platelets ≥ 100,000/mm3, bilirubin ≤ 1.5 x ULN (or ≤ 3 x ULN if Gilbert's syndrome), liver enzymes ≤ 3 x ULN (or ≤ 5 x ULN with metastases), albumin ≥ 2.8 g/dL, coagulation tests ≤ 1.5 x ULN, creatinine clearance ≥ 50 mL/min, urine protein-to-creatinine ratio ≤ 1 mg/mg
- Use of effective contraception during and after treatment as specified
- Female subjects of childbearing potential must have a negative pregnancy test or meet criteria for permanent sterilization or menopause
You will not qualify if you...
- Patients with fewer than one salvage treatment regimen or with further potentially curative options
- Relapsed pure seminoma for phase II
- Rising tumor markers at screening
- More than 16 weeks since last HDCT dose for phase II
- Prior treatment with zanzalintinib
- Recent anticancer therapy within 2 weeks before study treatment
- Recent radiation therapy within specified windows before treatment
- Prior hypersensitivity to etoposide not resolved by supportive care
- Known untreated or unstable brain metastases
- Concomitant use of certain anticoagulants and platelet inhibitors
- Prior active malignancy except specific treated cancers or disease-free for 3+ years
- Psychiatric or social conditions limiting compliance
- Uncontrolled or recent significant illnesses including cardiovascular, pulmonary, gastrointestinal, bleeding disorders
- Symptomatic lung lesions or major blood vessel invasion
- Active infections requiring systemic treatment (except prophylactic antimicrobials)
- Known active hepatitis B or C, HIV infection unless stable on therapy
- Non-healing wounds or ulcers except tumor-related skin lesions
- Malabsorption syndrome or uncompensated hypothyroidism
- Moderate to severe liver impairment or dialysis requirement
- History of organ or stem cell transplant
- Recent major or minor surgery without complete healing
- QTcF interval >480 ms on ECG
- Pregnant or breastfeeding females
- Inability to swallow oral medication
- Allergy to study treatment components
- Prior myocarditis
- Use of complementary medications within 2 weeks before study treatment
- Any condition compromising safety or ability to complete the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, United States, 46202
Actively Recruiting
Research Team
J
Jennifer King, MD
CONTACT
C
Christin Snow, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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