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Maintenance Zanzalintinib With Etoposide After HDCT in GCT

ConditionGerm Cell Tumor
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorIndiana University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histological or serological evidence of incurable, refractory or relapsed metastatic germ cell tumor, including seminoma, non-seminoma, and women with ovarian GCTs.

Must have received initial cisplatin-based combination chemotherapy AND demonstrated progression following at least one salvage regimen for advanced germ-cell neoplasm and now considered incurable with standard therapies, including further chemotherapy or surgery.

Subjects with relapsed primary mediastinal non-seminomatous germ-cell tumor (PMNSGCT) or late relapse (>2 years) not amenable to resection are eligible if they have received first line platinum-based chemotherapy and are deemed not amenable to surgical resection.

Histological or serological evidence of non-seminomatous GCT

Disqualifiers

Relapsed pure seminoma

Rising tumor markers (AFP and hCG) at time of screening per discretion of treating physician

Patients who completed 2nd cycle of HDCT (time since last dose of HDCT) > 16 weeks ago

Prior treatment with zanzalintinib

Trial design

Design model

Sequential

Treatments tested in this trial

  • Zanzalintinib

    Drug

    Two zanzalintinib doses of 40mg and 60mg. The initial starting dose of zanzalintinib will be 40mg. The patients will receive zanzalintinib orally daily continuously for 28 day cycles.

  • Etoposide Capsule

    Drug

    Oral daily for 21 days of each 28 day cycle.

Treatment groups

38 Participants
are divided into 2 treatment groups
Group A: Phase 1 Dose EscalationExperimental treatment 2 interventions
Group B: Phase II Dose ExpansionExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Phase 1: Rate of hematologic toxicity

Rate of hematologic toxicity including neutropenia, anemia, or thrombocytopenia requiring intervention (transfusions or antibiotics)

Time frame
28 days
2

Phase 1: Rate of non-hematologic toxicity

Rate of non-hematologic toxicity

Time frame
28 days
3

Phase II: 12-month Progression Free Survival

12-month PFS based on investigator determination of tumor progression (clinical, radiographic, and/or tumor markers including AFP and hCG)

Time frame
12 months

Secondary outcomes

1

Phase II: 12-month Overall Survival (OS)

12-month OS as determined from time of registration to death from any cause

Time frame
12 months post time of registration
2

Phase II: Incidence of Adverse Events

Toxicity measured by the NCI Common Terminology Criteria for Adverse Events (CTCAE) v5.0 and need for treatment delay, dose reduction, or early discontinuation.

Time frame
Start of treatment until end of treatment safety assessments (up to 2 years)

Other outcomes

Sponsors and contacts

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

Indiana University

Lead sponsor

Exelixis

Collaborator

Source ClinicalTrials.gov
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