50 Participants Needed

Cabozantinib for Germ Cell Tumors

CS
JK
Nabil Adra, MD | IU Health
Overseen ByNabil Adra, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise
Approved in 4 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

This trial is testing Cabozantinib, a drug that slows down or stops cancer cell growth. It is aimed at patients with germ cell tumors that do not respond to standard treatments. Cabozantinib works by blocking proteins that cancer cells need to grow.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications. However, you cannot have taken a small molecule kinase inhibitor within 2 weeks before starting the study treatment, and certain anticoagulants are not allowed. It's best to discuss your current medications with the trial team.

What data supports the effectiveness of the drug Cabozantinib for treating germ cell tumors?

Cabozantinib has shown effectiveness in treating various cancers, such as thyroid, ovarian, and prostate cancers, by targeting specific proteins that help tumors grow and spread. This suggests it might also be effective for germ cell tumors, although direct evidence for this specific use is not provided.12345

What safety data exists for cabozantinib in humans?

A phase 1 study on cabozantinib in children with solid tumors found it important to determine the maximum tolerated dose and understand its toxicity profile, which helps assess its safety in humans.678910

How is the drug Cabozantinib different from other treatments for germ cell tumors?

Cabozantinib is unique because it targets multiple receptor tyrosine kinases, which are proteins involved in the growth of cancer cells, making it potentially effective for tumors that do not respond to standard cisplatin-based chemotherapy.711121314

Research Team

JK

Jennifer King, MD

Principal Investigator

Indiana University

Eligibility Criteria

This trial is for adults over 18 with incurable, refractory germ cell tumors who have already undergone first-line cisplatin chemotherapy and at least one salvage regimen without success. They should not be candidates for further curative treatments like surgery. Participants must have acceptable organ function and performance status, understand the study protocol, and agree to use contraception if of childbearing potential.

Inclusion Criteria

I am not on blood thinners, or if I am, my dose has been stable.
My cancer is a type of testicular cancer that has come back after treatment.
My kidney function is within the required range and my protein levels in urine are low.
See 19 more

Exclusion Criteria

My intra-abdominal abscess has fully healed.
My high blood pressure is not controlled even with medication.
I don't have another active cancer, except for certain skin cancers, in situ cervical cancer, low-grade prostate cancer, or any cancer I haven't been treated for in over a year.
See 30 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients are treated with Cabozantinib 60mg orally daily continuously until disease progression, unacceptable toxicity, or trial closure

up to 1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 2 years

Treatment Details

Interventions

  • Cabozantinib
Trial OverviewThe trial is testing Cabozantinib in patients with germ cell tumors that haven't responded to standard therapies. Treatment continues until disease progression or unacceptable side effects occur. The goal is to see how effective this drug is in controlling the disease when other treatments have failed.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: CabozantinibExperimental Treatment1 Intervention
Patients will be treated with Cabozantinib 60mg orally daily continuously until disease progression, unacceptable toxicity, or trial closure.

Cabozantinib is already approved in European Union, United States, Canada, Japan for the following indications:

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Approved in European Union as Cabometyx for:
  • Renal cell carcinoma
  • Hepatocellular carcinoma
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Approved in United States as Cabometyx for:
  • Renal cell carcinoma
  • Hepatocellular carcinoma
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Approved in Canada as Cabometyx for:
  • Renal cell carcinoma
  • Hepatocellular carcinoma
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Approved in Japan as Cabometyx for:
  • Renal cell carcinoma

Find a Clinic Near You

Who Is Running the Clinical Trial?

Nabil Adra

Lead Sponsor

Trials
5
Recruited
190+

Jennifer King

Lead Sponsor

Trials
1
Recruited
50+

Exelixis

Industry Sponsor

Trials
126
Recruited
20,500+
Michael M. Morrissey profile image

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 profile image

Vicki L. Goodman

Exelixis

Chief Medical Officer since 2022

MD

Findings from Research

Cabozantinib (Cabometyx) has received approval for the treatment of locally advanced or metastatic differentiated thyroid cancer that has not responded to previous therapies targeting vascular endothelial growth factor receptors.
This approval highlights Cabozantinib's efficacy in addressing a specific type of thyroid cancer that has progressed after other treatments, providing a new option for patients.
New Indication for Cabozantinib.Aschenbrenner, DS.[2023]
In a study involving 111 patients with recurrent ovarian cancer, cabozantinib showed a median progression-free survival (PFS) of 5.3 months, which was similar to the 5.5 months achieved with weekly paclitaxel, indicating comparable initial treatment effectiveness.
However, cabozantinib had worse outcomes in overall survival (OS), event-free survival (EFS), and overall response rate (ORR) compared to paclitaxel, along with increased gastrointestinal side effects, leading to the conclusion that cabozantinib is not recommended for this patient population.
A randomized phase II study of cabozantinib versus weekly paclitaxel in the treatment of persistent or recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer: An NRG Oncology/Gynecologic Oncology Group study.Matulonis, UA., Sill, MW., Makker, V., et al.[2020]
Cabozantinib is an effective oral tyrosine kinase inhibitor that targets multiple receptors involved in cancer growth, showing antitumor activity in various cancers and is approved for specific types of advanced cancer.
Preclinical studies suggest that cabozantinib works well in combination with other cancer treatments, including immune checkpoint inhibitors, highlighting its potential for enhanced efficacy when used alongside other therapies.
Antitumor effects of the multi-target tyrosine kinase inhibitor cabozantinib: a comprehensive review of the preclinical evidence.Santoni, M., Iacovelli, R., Colonna, V., et al.[2022]

References

New Indication for Cabozantinib. [2023]
A randomized phase II study of cabozantinib versus weekly paclitaxel in the treatment of persistent or recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer: An NRG Oncology/Gynecologic Oncology Group study. [2020]
Antitumor effects of the multi-target tyrosine kinase inhibitor cabozantinib: a comprehensive review of the preclinical evidence. [2022]
Cabozantinib: a MET, RET, and VEGFR2 tyrosine kinase inhibitor. [2022]
A phase 2 randomised discontinuation trial of cabozantinib in patients with ovarian carcinoma. [2019]
A phase 1 study of cabozantinib in children and adolescents with recurrent or refractory solid tumors, including CNS tumors: Trial ADVL1211, a report from the Children's Oncology Group. [2020]
Treatment of refractory germ-cell tumours with single-agent cabazitaxel: a German Testicular Cancer Study Group case series. [2020]
ALK-rearranged non-small cell lung cancers: how best to optimize the safety of crizotinib in clinical practice? [2018]
Hematologic toxicities of sunitinib in patients with gastrointestinal stromal tumors: a systematic review and meta-analysis. [2022]
Investigating the efficacy of osimertinib and crizotinib in phase 3 clinical trials on anti-cancer treatment-induced cardiotoxicity: are real-world studies the way forward? [2023]
11.United Statespubmed.ncbi.nlm.nih.gov
Absence of c-KIT and members of the epidermal growth factor receptor family in refractory germ cell cancer. [2018]
Efficacy of Gemcitabine, Paclitaxel, and Oxaliplatin Protocol in the Treatment of Relapsed or Refractory Germ Cell Tumours. [2022]
13.United Statespubmed.ncbi.nlm.nih.gov
Treatment of patients with cisplatin-refractory testicular germ-cell cancer. German Testicular Cancer Study Group (GTCSG). [2022]
Expression of KIT and epidermal growth factor receptor in chemotherapy refractory non-seminomatous germ-cell tumors. [2020]