Palbociclib plus letrozole treatment for women ovarian cancer

Phase 2

• Conditions: Secondary malignant neoplasms of ovary; C79.6

• Registration Number: RBR-8k2928
• Lead Sponsor: atin American Cooperative Oncology Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-01-21
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study;subject is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures; eighteen years of age or older; patient agrees not to participate in another interventional study while on treatment; histologically diagnosed endometrioid or high-grade serous ovarian cancer, estrogen and or progesterone receptor positive, defined as more than ten percent by immunohistochemistry;
NOTE: The ER and PR status must be centrally reviewed before treatment allocation. Patients must have completed two previous courses of chemotherapy: The penultimate regimen must be a platinum based chemotherapy course prior to enrolment on the study: For the last chemotherapy course prior to enrolment on the study: There is no prespecified regimen; it may contain a Platinum salt or not, depending upon Platinum sensitivity, at discretion of treating Physician; patients must have demonstrated disease progression by RECIST v1.1 to the last treatment. Patients must be treated on the study within eight weeks of completion of their final dose of second line regimen; formalin fixed, paraffin embedded tumor sample from the primary tumor must be available for central testing; eastern One. Cooperative Oncology Group performance status Two; adequate bone marrow function at screening: Absolute Neutrophil Count 1,500 to mm³. Platelets 100,000 to mm³. Hemoglobin 9.0 g to dL; adequate liver function at screening: Total serum bilirubin 1.5 x upper limit of normal, 3.0 x ULN if Gilbert Syndrome. Aspartate aminotransferase and alanine aminotransferase 3.0 x ULN, 5.0 x ULN if there is tumor involvement in the liver. Alkaline phosphatase 2.5 x ULN, 5.0 x ULN if there is tumor involvement in the liver; adequate renal function at screening: Serum creatinine 1.5 x ULN or estimated creatinine clearance 50mL to min; evidence of nonchildbearing potential: Postmenopausal, defined as at least one year without any menses, prior to screening, or radiation induced oophorectomy with last menses more than one year ago, or surgical sterilisation, bilateral oophorectomy or hysterectomy.

Exclusion Criteria

Patients with a known hypersensitivity to Palbociclib or Letrozole or any of the excipients of the product; previous treatment with CDK inhibitors or endocrine therapy; persistent toxicities, grade two or greater, caused by previous cancer therapy, excluding alopecia; patients with second primary cancer, except: adequately treated non melanoma skin cancer, curatively treated in-situ cancer of the cervix, Ductal Carcinoma in Situ, stage one grade one endometrial carcinoma curatively treated with no evidence of disease for three years; patients receiving any chemotherapy, radiotherapy, within three weeks from the last dose prior to study entry; patients with symptomatic uncontrolled brain metastases. A scan to confirm the absence of brain metastases is not required; major surgical procedure within three weeks prior to study randomization, or one is planned during the course of the study; patients considered poor medical risk due to a serious, uncontrolled medical disorder, non malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent, within six months, myocardial infarction, cerebrovascular accident, gastrointestinal bleeding, or any psychiatric disorder that prohibits obtaining informed consent; patients that have difficulty taking oral medication or any digestive tract dysfunction or inflammatory bowel disease that would interfere with the intestinal absorption of drugs, eg, partial bowel obstruction or malabsorption; patients have received potent inhibitors or inducers of CYPthreeAfour within seven days prior to randomization; pregnant or breast feeding women; patient has a known history of positive test for human immunodeficiency virus; patients with known hepatic disease, ie, Hepatitis B or C; subjects who are investigational site staff members directly involved in the conduct of the trial and their family members, site staff members otherwise supervised by the Investigator, or subject who are Pfizer employees directly involved in the conduct of the trial; treatment with any investigational product during the last twenty-eight days; QTc greater than 480ms, QT syndrome, Brugada syndrome, history QTc prolongation or Torsade de Points; other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate 12 week PFS, defined as the proportion of patients who are alive, progression-free by RECIST v1.1, and on treatment at the 12-week evaluation time-point

Secondary Outcome Measures

Name	Time	Method
Observe effectiveness through overall response rate, duration of response, OS at year 1 and 2, Clinical Benefit Rate (CBR), CA-125 response (GCIG criteria), time to progression by CA-125 (GCIG criteria) or RECIST, Quality of Life (QoL) and safety.