Study for patients with relapsed, refractory, incurable teratoma with recent progression. The study is randomized (the patient may receive the investigational drug or placebo) and it is blinded (the patient and the study doctor will not know what drug the patient receives).
- Conditions
- relapsed, refractory, incurable teratomaTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2014-000428-12-NL
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 42
1. Diagnosis of teratoma for which no additional standard surgical or medical therapy
exists
2. Patients must have completed at least 1 prior line of chemotherapy for germ cell tumor
3. Radiographic progression, defined by RECIST v.1.1, after the last cancer treatment and within 12 weeks
prior to enrollment, compared with scans within 1 year of enrollment.
4. Availability of an archival or newly obtained tumor sample (collected at diagnosis or progression) with accompanying pathology report
5. Measurable or evaluable extra-cranial disease as defined by RECIST v 1.1
Other protocol-defined inclusion criteria may apply
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 22
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5
1. Malignant germ cell tumors with mixed histology such as embryonal carcinoma, choriocarcinoma, yolk sac tumor or
seminoma
2. Pathologic evidence of malignant transformation
3. CNS disease unless radiation therapy and/or surgery has been completed and serial evaluation demonstrates stable disease
4. Prior treatment with any CDK4/6 inhibitor therapy
5. Systemic antineoplastic therapy or any experimental therapy within 3 weeks before the first dose of study drug (6 weeks for prior nitrosoureas, bevacizumab, or mitomycin C)
6. Major surgery = 2 weeks or radiotherapy = 4 weeks prior to planned start of study drug or patient has not
recovered from major side effects.
7. Requirement for treatment with any of the prohibited medications including strong CYP3A4/5 inhibitors, strong CYP3A4/5 inducers, CYP3A4/5 substrates with a narrow therapeutic index, and medications with strong risk of QT prolongation.
Other protocol-defined Exclusion criteria may apply
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method