Phase II Study of Cabozantinib for Patients with Hard-to-Treat Germ Cell Tumors
Sponsor: Jennifer King
ClinicalTrials ID:NCT04876456
This clinical trial is exploring the use of Cabozantinib for patients with germ cell tumors that are difficult to treat and have not responded to other therapies. Participants will continue treatment until their disease progresses, they choose to stop, or if the study ends for any reason.
Patient Parameters
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Program Overview
The purpose of this study is to test the effectiveness of Cabozantinib in patients with germ cell tumors that are hard to treat and have not responded to other treatments. Participants will receive the medication until their cancer progresses, they experience severe side effects, they decide to withdraw, or if the study is closed for any reason.
Eligibility Criteria
Exclusion Criteria
- Previously treated with Cabozantinib.
- Taken any small molecule kinase inhibitor within 2 weeks before starting the study treatment.
- Have not received at least one salvage treatment regimen or have other potential curative treatment options.
- Have untreated or unstable brain metastases unless treated and stable for at least 4 weeks before starting the study treatment.
- Received radiation therapy for bone metastasis within 2 weeks, or any other radiation therapy within 4 weeks before starting the study treatment.
- Planning to father children during the study and up to 120 days after the last dose.
- Treated with any investigational agent or anticancer therapy within 28 days before starting the study treatment.
- Have another active cancer, except for certain skin cancers or other cancers that have not required treatment for at least 1 year.
- Have psychiatric or social conditions that would prevent following the study requirements.
- Have uncontrolled or significant recent illnesses, including:
- Serious heart conditions like heart failure, unstable chest pain, or serious heart rhythm problems.
- Uncontrolled high blood pressure.
- Recent stroke, heart attack, or blood clot within 6 months before starting the study treatment.
- Certain gastrointestinal disorders with a high risk of complications.
- Significant bleeding within 12 weeks before starting the study treatment.
- Lung lesions or disease affecting major airways.
- Lesions involving major blood vessels.
- Serious non-healing wounds or fractures.
- Severe liver impairment.
- Major surgery within 2 weeks or minor surgery within 10 days before starting the study treatment.
- Abnormal heart rhythm as shown on an ECG.
- Taking certain blood thinners that are not allowed in the study.
- Pregnant or breastfeeding women.
- Unable to swallow tablets.
- Known allergy to components of the study treatment.
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