Ribociclib (Ribociclib (LEE-011)) With Platinum-based Chemotherapy in Recurrent Platinum Sensitive Ovarian Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03056833|
Recruitment Status : Active, not recruiting
First Posted : February 17, 2017
Last Update Posted : August 26, 2020
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer Fallopian Tube Cancer Peritoneal Carcinoma||Drug: ribociclib Drug: Paclitaxel Drug: Carboplatin||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||42 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Trial of Ribociclib (Ribociclib (LEE-011)) With Platinum-based Chemotherapy in Recurrent Platinum Sensitive Ovarian Cancer|
|Actual Study Start Date :||June 10, 2017|
|Actual Primary Completion Date :||June 1, 2020|
|Estimated Study Completion Date :||August 1, 2021|
Ribociclib (LEE-011) will be used as concurrent therapy with platinum-based chemotherapy in platinum-sensitive recurrent ovarian cancer. Participants will receive 200, 400, or 600mg of ribociclib per day in combination with carboplatin + paclitaxel. Subjects will receive 6 cycles of carboplatin + paclitaxel given weekly with ribociclib.
Ribociclib (LEE-011) will be given on days 1-4, 8-11, and 15-18 of a 28 day cycle at 200, 400, or 600mg/day during the dose escalation phase. During the maintenance phase, ribociclib (LEE-011) will be given at 600mg/day, 3 weeks on, 1 week off until progression.
During the escalation phase Paclitaxel will be given on days 1, 8, and 15 of a 28 day cycle.
During the escalation phase Carboplatin will be given on days 1, 8, and 15 of a 28 day cycle.
- Maximal tolerated dose (MTD) of ribociclib (LEE-011) when given with carboplatin + paclitaxel in platinum-sensitive recurrent ovarian cancer [ Time Frame: 56 days ]Participants will be observed for the first two treatment cycles (2, 28 day cycles) and maximum tolerated dose will be determined.
- Number of participants that respond to treatment [ Time Frame: 18 months post treatment ]Overall response rate (ORR) will be analyzed. The number of patients that respond to treatment (exhibit Partial Response (PR) or Complete Response (CR)) will be recorded. PR is defined as at least a 50% reduction in CA 125 levels (response must be confirmed and maintained for at least 28 days) and/or at least 30% decrease in the sum diameters of target lesions. CR is defined as normalization of CA125 levels ((response must be confirmed and maintained for at least 28 days) and disappearance of all target lesions.
- Time from treatment until disease progression or death [ Time Frame: 18 months post treatment ]
Progression is defined as one of the following:
- Patients with elevated CA-125 pretreatment and normalization of CA-125 must show evidence of CA-125 greater than, or equal to, 2 times the upper limit of the reference range on 2 occasions at least 1 week apart or
- Patients with elevated CA-125 before treatment, which never normalizes, must show evidence of CA-125 greater than, or equal to, 2 times the nadir value on 2 occasions at least 1 week apart or
- Patients with CA-125 in the reference range before treatment must show evidence of CA-125 greater than, or equal to, 2 times the upper limit of the reference range on 2 occasions at least 1 week apart
- Increase in at least 20% in sum of diameters of target lesions or any new lesions or unequivocal increase in non-target lesions.
- Response determined via measurable disease (measurement of target and non-target lesions) takes precedence over CA125 criteria Stable Disease (SD): CA
- Number of participants encountering toxicity at each dose level [ Time Frame: 30 days post treatment ]Patients will potentially be treated with 3 different dose levels of ribociclib in combination with platinum-based chemotherapy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03056833
|United States, Michigan|
|University of Michigan Comprehensive Cancer Center|
|Ann Arbor, Michigan, United States, 48109|
|United States, Pennsylvania|
|UPMC Hillman Cancer Center Upper St. Clair|
|Bethel Park, Pennsylvania, United States, 15102|
|UPMC Hillman Cancer Center Arnold Palmer at Mountain View|
|Greensburg, Pennsylvania, United States, 15601|
|UPMC Hillman Cancer Center Arnold Palmer Medical at Norwin|
|Irwin, Pennsylvania, United States, 15642|
|UPMC Hillman Cancer Center Arnold Palmer at Mt Pleasant|
|Mount Pleasant, Pennsylvania, United States, 15666|
|University of Pittsburgh Medical Center|
|Pittsburgh, Pennsylvania, United States, 15213|
|UPMC Hillman Cancer Center Passavant (OHA)|
|Pittsburgh, Pennsylvania, United States, 15237|
|UPMC Hillman Cancer Center Washington|
|Washington, Pennsylvania, United States, 15301|
|Principal Investigator:||Lan G Coffman, M.D.||University of Pittsburgh Medical Center|