Zanzalintinib + Etoposide for Germ Cell Cancer

Overseen By Christin Snow, RN

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Indiana University

Must not be taking: Anticoagulants, Platelet inhibitors

Disqualifiers: Brain metastases, Uncontrolled hypertension, Active infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 28

38 Participants Needed

Trial Summary

What is the purpose of 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.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications. However, you cannot take certain medications like oral anticoagulants or complementary medicines within 2 weeks before starting the study treatment. It's best to discuss your current medications with the study team.

What data supports the effectiveness of the drug combination Zanzalintinib and Etoposide for treating germ cell cancer?

Etoposide is a well-established drug for treating germ cell cancer, often used in combination with other drugs like cisplatin, and has shown effectiveness in both initial and resistant cases. While Zanzalintinib is not specifically mentioned, the combination with etoposide could potentially enhance treatment outcomes based on etoposide's proven track record. ^{1 2 3 4 5}

Research Team

Jennifer King, MD

Principal Investigator

Indiana University Simon Comprehensive Cancer Center

Eligibility Criteria

Adults (≥18 years) with relapsed germ cell tumors after initial cisplatin-based chemotherapy, who've completed salvage treatment with high-dose chemotherapy and stem cell transplant. They must have adequate organ function, no severe recent illnesses or conditions that could interfere with the trial, not be pregnant or breastfeeding, and agree to use effective contraception.

Inclusion Criteria

My cancer returned after first treatment with cisplatin.

I've completed 2 cycles of high-dose chemotherapy and stem cell transplant.

For All Patients:

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1 Dose Escalation

Evaluation of three doses of zanzalintinib for toxicity in combination with oral etoposide

28 days

Continuous daily dosing with safety assessments

Phase II Dose Expansion

Maintenance treatment with zanzalintinib and etoposide until progression or toxicity

Up to 24 months

28-day cycles with regular monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Treatment Details

Interventions

• Etoposide
• Zanzalintinib

Trial Overview The trial is testing Zanzalintinib in combination with oral Etoposide as a maintenance therapy for patients with relapsed germ cell tumors following high-dose chemotherapy and stem cell transplant. It's an open-label phase I/II study designed to assess safety and efficacy.

Participant Groups

Group I: Phase II Dose Expansion Experimental Treatment 2 Interventions

Group II: Phase 1 Dose Escalation Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

Exelixis

Industry Sponsor

Trials

126

Recruited

20,500+

Michael M. Morrissey

Exelixis

Chief Executive Officer since 2010

PhD in Chemistry from Harvard University, BSc in Chemistry from the University of Wisconsin

Vicki L. Goodman

Exelixis

Chief Medical Officer since 2022

MD

References

1. United States pubmed.ncbi.nlm.nih.gov

The role of etoposide therapy in germ cell cancer. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Long-term follow-up of patients with good-risk germ cell tumors treated with etoposide and cisplatin. [2017]

3. United States pubmed.ncbi.nlm.nih.gov

High-dose carboplatin and etoposide with autologous bone marrow transplantation in refractory germ cell cancer: an Eastern Cooperative Oncology Group protocol. [2017]

4. Japan pubmed.ncbi.nlm.nih.gov

[Treatment of metastatic germ cell tumors with etoposide and cisplatin as first line chemotherapy]. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Randomized trial of etoposide and cisplatin versus etoposide and carboplatin in patients with good-risk germ cell tumors: a multiinstitutional study. [2017]