Trial of Letrozole + Palbociclib/Placebo in Metastatic Endometrial Cancer
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|ClinicalTrials.gov Identifier: NCT02730429|
Recruitment Status : Recruiting
First Posted : April 6, 2016
Last Update Posted : October 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Endometrial Cancer||Drug: Palbociclib/placebo Drug: Letrozole||Phase 2|
This multicenter, prospective, randomized, double-blind, placebo-controlled phase 2 study is evaluating the efficacy of letrozole-palbociclib combination against letrozole-placebo combination in women with ER+ advanced or relapsed endometrial cancer.
Patients are stratified according to:
- Number of prior lines of therapy (primary advanced disease vs. 1st relapse vs. ≥2 relapses)
- Measurable vs. evaluable disease
- Prior use of MPA/Megace
Randomization 1:1 randomization The patients with prior MPA/Megace treatment will be capped to a maximum of 50%.
Patients are randomized to one of the two treatment arms:
- Arm A: (comparator) letrozole-placebo combination therapy until progression.
- Arm B: (experimental arm): Letrozole- palbociclib combination therapy until progression
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||78 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||randomized, double-blind, placebo-controlled|
|Masking:||Double (Participant, Investigator)|
|Official Title:||ENGOT-EN3-NSGO/PALEO: A Randomized, Double-blind, Placebo-controlled, Phase II Trial of Palbociclib in Combination With Letrozole Versus Placebo in Combination With Letrozole for Patients With Estrogen Receptor Positive Advanced or Recurrent Endometrial Cancer.|
|Actual Study Start Date :||February 15, 2017|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2022|
Placebo Comparator: Letrozole + placebo
letrozole 2.5mg once daily days 1-28 every 28 days shall be administered until progression of disease or unacceptable toxicity. Letrozole is administered as standard of care in both study arms.
Placebo for palbociclib once daily days 1-21 every 28 days shall be administered until progression of disease or unacceptable toxicity.
Letrozole is standard of care in both arms
Experimental: Letrozole + palbociclib
Palbociclib 125mg once daily days 1-21 every 28 days shall be administered until progression of disease or unacceptable toxicity.
letrozole 2.5mg once daily days 1-28 every 28 days shall be administered until progression of disease or unacceptable toxicity.
Letrozole is administered as standard of care in both study arms.
Palbociclib or a placebo is administered together with standard of care letrozole
Letrozole is standard of care in both arms
- Progression-Free Survival (PFS). Increase in median PFS in experimental arm versus comparator arm [ Time Frame: 26 months ]To be measured (in months) and reported
- PFS of patients in the sub-populations as described under stratification factors. Increase in median PFS in experimental arm versus comparator arm [ Time Frame: 26 months ]To be measured (in months) and reported
- Overall Response Rate (ORR) according to RECIST [ Time Frame: 26 months ]To be measured (in %) and reported
- Disease Control Rate (DCR) for at least 12 weeks [ Time Frame: 26 months ]To be measured (in %) and reported
- Time to First Subsequent Therapy (TFST) [ Time Frame: 36 months ]TFST: time from randomization to first subsequent therapy or death. To be measured (in months) and reported
- Progression-Free Survival 2 (PFS2) [ Time Frame: 48 months ]PFS2: time from randomization to second objective disease progression or death. To be measured (in months) and reported
- Time to Second Subsequent Therapy (TSST) [ Time Frame: 48 months ]TSST: time from randomization to second subsequent therapy or death.To be measured (in months) and reported
- Patient Reported Outcomes (PROs) like Quality of Life questionnaire EORTC-QLQ-C30 & EORTC-QLQ-EN24 [ Time Frame: 48 months ]These are the validated questionnaires to be answered by patients. Results to be reported as descriptive and on a scale of 1-10
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 48 months ]To be reported on %
- Compliance in the two treatment arms. [ Time Frame: 48 months ]Missed dosages in both arm will be reported.
- Dose reductions/interruptions in the two treatment arms [ Time Frame: 48 months ]To be reported on %
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): NCT02730429
|Contact: Mansoor R Mirza, MDfirstname.lastname@example.org|
|Contact: Pernille Strøm, RN||Pernille.Stroem@regionh.dk|
|Copenhagen, Sjaelland, Denmark, 2100|
|Contact: Pernille Strøm, RN email@example.com|
|Study Chair:||Mansoor R Mirza, MD||NSGO|