LEE011 for Patients With CDK4/6 Pathway Activated Tumors (SIGNATURE) (SIGNATURE)
|ClinicalTrials.gov Identifier: NCT02187783|
Recruitment Status : Active, not recruiting
First Posted : July 11, 2014
Last Update Posted : October 26, 2017
|Condition or disease||Intervention/treatment||Phase|
|Tumors With CDK4/6 Pathway Activation||Drug: LEE011||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||106 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Modular Phase II Study to Link Targeted Therapy to Patients With Pathway Activated Tumors: Module 8 - LEE011 for Patients With CDK4/6 Pathway Activated Tumors|
|Actual Study Start Date :||August 25, 2014|
|Estimated Primary Completion Date :||October 31, 2017|
|Estimated Study Completion Date :||October 31, 2017|
Adult patients with a diagnosis of a solid tumor or hematological malignancy that have been pre-identified as having relevant CDK4/6, cyclin D1/3, or p16 aberrations. Patients must have received at least one prior treatment for their recurrent, metastatic and/or locally advanced disease and have no remaining standard therapy options anticipated to result in a durable response.
LEE011 600 mg (hard gelatin capsules) will be administered orally once daily for 3 weeks on/1 week off. A complete treatment cycle is defined as 28 days.
- Clinical benefit rate associated with LEE011 treatment [ Time Frame: 16 weeks ]Clinical benefit rate for patients with solid tumors will be assessed using RECIST 1.1 and will include responses of CR or PR or SD. For hematologic tumors other appropriate hematological response criteria will apply.
- Overall Response (OR) of Partial Response (PR) or greater [ Time Frame: Baseline and every 8 weeks until disease progression or end of treatment, assessed up to 24 months ]Overall Response (OR) of Partial Response (PR) or greater based on local investigator assessment. For patients with solid tumors, the assessment criteria will be RECIST 1.1 and will include responses of CR and/or PR. For hematologic tumors other appropriate hematological response criteria will apply.
- Progression Free Survival (PFS) [ Time Frame: Every 8 weeks until death, assessed up to 24 months ]Progression free survival (PFS) is defined as the time from the date of first dose to the date of first documented disease progression or relapse or death due to any cause
- Overall Survival (OS) [ Time Frame: Every 8 weeks until death, assessed up to 36 months ]Overall survival (OS) is defined as the time from the date of first dose to the date of death due to any cause.
- Duration of Response (DOR) [ Time Frame: Baseline and every 8 weeks until disease progression or end of treatment, assessed up to 24 months ]Duration of response (DOR) is defined as time from the first documented response to the date first documented disease progression or relapse or death due to any cause.
- Safety and tolerability [ Time Frame: Baseline up to 30 days after last study treatment ]Safety and tolerability will be based on the frequency of adverse events and on the number of laboratory values that fall outside of pre-determined ranges. Other safety data (e.g., electrocardiogram, vital signs) will be considered as appropriate.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02187783
Show 61 Study Locations