Palbociclib Plus Letrozole Treatment After Progression to Second Line Chemotherapy for Women With ER/PR-positive Ovarian Cancer. (LACOG1018)
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|ClinicalTrials.gov Identifier: NCT03936270|
Recruitment Status : Not yet recruiting
First Posted : May 3, 2019
Last Update Posted : May 3, 2019
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer||Drug: Palbociclib 125mg Drug: Letrozole 2.5mg||Phase 2|
Letrozole (Femara®) is an oral non-steroidal aromatase inhibitor that is approved worldwide for the treatment of postmenopausal women with breast cancer. It is administered orally on a continuous 2.5 mg daily dosing regimen and has a good toxicity profile. Palbociclib (Ibrance®) is an active potent and highly selective reversible inhibitor of cyclin- dependent kinases 4 and 6 (CDK4/6). Palbociclib was approved by the United States Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) for the treatment of postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with an aromatase inhibitor based on a randomized, double-blind, placebo-controlled, international clinical trial PALOMA-2. It is administered orally on a dose of 125 mg per day in 4-week cycles (3 weeks of treatment followed by 1 week off). This trial was based on preclinical studies that showed a synergistic effect between targeting the ER and cyclin-D-CDK4/6-Rb pathway. The principal toxicity was myelotoxicity but it was managed with appropriate supportive care and dose reductions13.
Based on the results of phase 1 and 2 clinical trials of CDK4/6 inhibitors used as monotherapy to treat patients with recurrent ovarian cancer, we hypothesized that, as Palbociclibe is active in this population and many ovarian cancer show ER/PR expression, its combination with Letrozole can improve outcomes in ER/PR positive endometrioid or high-grade serous Ovarian Cancer who have disease progression on second-line chemotherapy, similar to what is seen in breast cancer studies.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||39 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Palbociclib Plus Letrozole Treatment After Progression to Second Line Chemotherapy for Women With ER/PR-positive Ovarian Cancer.|
|Estimated Study Start Date :||May 15, 2019|
|Estimated Primary Completion Date :||February 4, 2020|
|Estimated Study Completion Date :||February 4, 2021|
Experimental: Palbociclib 125mg + Letrozole 2.5mg
Palbociclib 125mg per day, administered orally in 4-week cycles (3 weeks of treatment followed by 1 week off) PLUS Letrozole 2.5mg per day administered orally (continuous treatment).
Drug: Palbociclib 125mg
The Palbociclib capsules supplied for this study contains 75 mg, 100 mg or 125 mg of Palbociclib. It must be taken orally 125 mg once daily for 21 consecutive days followed by 7 days off treatment (Schedule 3/1) to comprise a complete cycle of 28 days.
Other Name: Ibrance®
Drug: Letrozole 2.5mg
Letrozole will be supplied as a 2.5 mg film-coated tablet. It must be taken at the recommended dose of 2.5 mg once daily.
Other Name: Femara
- Twelve weeks of Progression Free Survival [ Time Frame: 12 weeks ]The primary objective of this study is to evaluate 12 weeks progression-free survival (PFS) rate of Palbociclib plus Letrozole in ER/PR positive endometrioid or high-grade serous ovarian cancer who have disease progression on second-line chemotherapy.
- Overall response [ Time Frame: 2 years ]defined as the proportion of patients who have a partial or complete response to therapy according to RECIST 1.1
- Overall Survival [ Time Frame: 2 years ]Overall Survival at year 1 and 2
- Clinical Benefit Rate [ Time Frame: 2 years ]defined as the proportion of patients who have achieved complete response, partial response and stable disease for at least 24 weeks.
- Duration of response [ Time Frame: 2 years ]defined as the time from response to progression by RECIST v11.1 or death
- CA-125 response (GCIG criteria) [ Time Frame: 2 years ]defined as the proportion of patients who have achieved at least a 50% reduction in CA 125 levels from a pretreatment sample (must be confirmed and maintained for at least 28 days)
- Time to progression by CA-125 (GCIG criteria) or RECIST [ Time Frame: 2 years ]defined as the time from response to progression by CA 125 (GCIG criteria) or RECIST
- Quality of Life (FACT-O questionnaire) [ Time Frame: 2 years ]assessed using the FACT-O questionnaire
- Safety (adverse events) [ Time Frame: 2 years ]defined as the proportion of patients who present adverse events
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): NCT03936270
|Contact: Laura Voelcker||+55 51 3384 firstname.lastname@example.org|
|Porto Alegre, Rio Grande Do Sul, Brazil|
|Contact: Raíra Maschmann|
|Study Director:||Gustavo Werutsky, MD||Latin American Cooperative Oncology Group|