A randomized, blinded, placebo-controlled, phase II trial of LEE011 in patients with relapsed, refractory, incurable teratoma with recent progressio

Phase 2

Completed

• Conditions: organoid tumor; Teratoma; 10027656

• Registration Number: NL-OMON41774
• Lead Sponsor: ovartis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 6

Inclusion Criteria

1. Age > 15 years old at time of informed consent.
2. Diagnosis of teratoma for which no additional standard surgical or medical therapy exists.
3. Availability of an archival or newly obtained tumor sample accompanying pathology report.
* Patients without a tumor sample may be permitted to participate after discussion between Novartis and the investigator.
4. Patients must have completed at least 1 prior line of chemotherapy for germ cell tumor.
5. 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.
6. Measurable or evaluable extra-cranial disease as defined by RECIST v.1.1.
7. Patients must have ECOG performance status of 0-1.
8. Written informed consent/assent before any study-specific screening procedures.

Exclusion Criteria

1. CNS disease unless radiation therapy and/or surgery has been completed and serial evaluation by CT (with contrast enhancement) or MRI over a minimum of 2 months demonstrates stable disease.
2. Malignant germ cell tumors other than that being treated in this study
3. Concurrent malignancy other than teratoma within 3 years of randomization
4. Prior treatment with any CDK4/6 inhibitor therapy
5. Any concurrent severe and/or uncontrolled medical condition that, in the investigator*s judgment serves as a contraindication to patient participation
6. Patients who have not recovered to * CTCAE grade 1 from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Progression Free Survival (PFS) as per RECIST v1.1 </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Best Overall Response (BOR),<br /><br>Overall response rate (ORR)<br /><br>Disease Control Rate (DCR) at 4 months as per RECIST v1.1,<br /><br>Overall Survival (OS), and OS rate at 12 months.<br /><br><br /><br>Incidence and severity of adverse events, serious adverse events, changes in<br /><br>laboratory values, electrocardiograms, and vital signs to assess the safety as<br /><br>per CTCAE v.4.03.<br /><br>Dose interruptions and changes will be used to assess the tolerability.</p><br>