Status:
COMPLETED
A Randomized, Blinded, Placebo-controlled, Phase II Trial of LEE011 in Patients With Relapsed, Refractory, Incurable Teratoma With Recent Progression
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Teratoma
Eligibility:
All Genders
15+ years
Phase:
PHASE2
Brief Summary
This was a multi-center, randomized, double blind (investigator and subject), placebo controlled Phase II study to determine the efficacy and safety of treatment with ribociclib versus placebo in subj...
Detailed Description
Safety follow-up: After discontinuation of study treatment, all subjects were followed for safety for 30 days except in the case of death, loss to follow up, withdrawal of consent, or discontinuation ...
Eligibility Criteria
Inclusion
- Key
- Diagnosis of teratoma for which no additional standard surgical or medical therapy exists
- Patients must have completed at least 1 prior line of chemotherapy for germ cell tumor (except patients who present with primary pure teratoma who need not have received any previous chemotherapy)
- 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.
- Availability of an archival or newly obtained tumor sample (collected at diagnosis or progression) with accompanying pathology report
- Meaurable or evaluable extra-cranial disease as defined by RECIST v 1.1
- Key
Exclusion
- Malignant germ cell tumors with mixed histology such as embryonal carcinoma, choriocarcinoma, yolk sac tumor or seminoma. Note - this refers to the histology at the time of enrollment, not the histolgy at the time of initial presentation.
- Pathologic evidence of malignant transformation
- CNS disease unless radiation therapy and/or surgery has been completed and serial evaluation demonstrates stable disease
- Prior treatment with any CDK4/6 inhibitor therapy
- 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)
- Major surgery ≤ 2 weeks or radiotherapy ≤ 4 weeks prior to planned start of study drug or patient has not recovered from major side effects.
- Requirement for treatment with any of the prohibited medications including strong CYP3A inhibitors, strong CYP3A inducers, CYP3A substrates with a narrow therapeutic index, and medications with strong risk of QT prolongation
Key Trial Info
Start Date :
February 26 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 21 2018
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT02300987
Start Date
February 26 2015
End Date
February 21 2018
Last Update
October 26 2020
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
USC Kenneth Norris Comprehensive Cancer Center Oncology Dept
Los Angeles, California, United States, 90033
2
New Mexico Cancer Care Alliance
Albuquerque, New Mexico, United States, 87106
3
Memorial Sloan Kettering Oncology Department.
New York, New York, United States, 10017
4
Novartis Investigative Site
Villejuif, France, 94800