A Randomized, Blinded, Placebo-controlled, Phase II Trial of LEE011 in Patients With Relapsed, Refractory, Incurable Teratoma With Recent Progression

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02300987
• Date of registration: 15/07/2014
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharmaceuticals
• Public title: A Randomized, Blinded, Placebo-controlled, Phase II Trial of LEE011 in Patients With Relapsed, Refractory, Incurable Teratoma With Recent Progression
• Scientific title: A Randomized, Blinded, Placebo-controlled, Phase II Trial of LEE011 in Patients With Relapsed, Refractory, Incurable Teratoma With Recent Progression
• Date of first enrolment: February 26, 2015
• Target sample size: 10
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02300987
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 2

Countries of recruitment

Denmark, France, Italy, Netherlands, Spain, United States

Contacts

• Name: Novartis Pharmaceuticals
• Affiliation: Novartis Pharmaceuticals

Key inclusion & exclusion criteria

Key Inclusion Criteria:

- 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 Criteria:

- 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



Age minimum: 15 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Teratoma

Intervention(s)

Drug: LEE011

Drug: LEE011 Placebo

Primary Outcome(s)

Progression Free Survival (PFS) [Time Frame: At 24 months]

Secondary Outcome(s)

Best Overall Response (BOR) [Time Frame: At 24 months]

Disease Control Rate (DCR) [Time Frame: At 24 months]

Overall Response Rate [Time Frame: At 27 months]

Overall Survival (OS) [Time Frame: At 27 months]

Overall Survival Rate [Time Frame: 1, 2, 3, 6, 9, 12, 15, 18, 21, 24 and 27 months]

Secondary ID(s)

2014-000428-12

CLEE011X2201

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 26/10/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02300987