A Phase II Trial of Cabozantinib With Patients With Refractory GCTs (NCT04876456) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Phase II Trial of Cabozantinib With Patients With Refractory GCTs
United States50 participantsStarted 2021-06-10
Plain-language summary
The purpose of the CTO-IUSCCC-0752 study is to investigate the use of Cabozantinib for patients with incurable, refractory germ cell tumors. Patients will be treated until evidence of disease progression, non-compliance with study protocol, unacceptable major toxicity, at subject's own request for withdrawal, or if the study closes for any reason.
Who can participate
SexALL
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Inclusion criteria
✓. Written informed consent and HIPAA authorization for release of personal health information.
✓. Capable of understanding and complying with the protocol requirements.
✓. Age ≥ 18 years at the time of consent.
✓. Histological or serological evidence of germ cell tumor, including seminoma, non-seminoma, and women with ovarian GCTs.
✓. Must have progressed after first-line cisplatin based combination chemotherapy AND demonstrated progression following at least one salvage regimen for advanced germ cell and now considered incurable with standard therapies, including further chemotherapy or surgery.
✓.1. "Failure" of prior therapy is defined as: 5.1.1. A \>25% increase in the products of the perpendicular diameters of measurable tumor masses during prior therapy which are not amenable to surgical resection.
✓.1.2. The presence of new tumors that are not amenable to surgical resection 5.1.3. An increase in AFP or beta-hcg (two separate determinations at least one week apart are required if rising tumor markers are the only evidence of failure).
✓. Subjects with relapsed primary mediastinal non-seminomatous germ cell tumor (PMNSGCT) are eligible
Exclusion criteria
✕. Prior treatment with Cabozantinib.
✕. Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks before first dose of study treatment.
What they're measuring
1
Clinical benefit rate
Timeframe: Start of the treatment until time of death or last follow up visit (up to 2 years)
✕. Subjects who have not received ≥1 salvage treatment regimens (except late relapse) or have further potentially curative treatment options.
✕. Known brain metastases or cranial epidural disease unless adequately treated and stable for at least 4 weeks prior to first dose of study treatment. Subjects must have complete wound healing from major surgery or minor surgery before first dose of study treatment. Eligible subjects must be neurologically asymptomatic at the time of first dose of study treatment.
✕. Radiation therapy for bone metastasis within 2 weeks, or any other radiation therapy within 4 weeks prior to first dose of study treatment.
✕. Expecting to father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
✕. Treatment with investigational agent, any type of cytotoxic, biologic or other systematic anticancer therapy within 28 days prior to registration for protocol therapy.
✕. Subjects with another active malignancy is not allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, Gleason \< Grade 7 prostate cancers, or other cancer for which the subject has not required therapy for ≥1 year.