Palbociclib Plus Letrozole Treatment After Progression to Second Line Chemotherapy for Women With ER/PR-positive Ovarian Cancer.

NCT03936270

Last updated date
Study Location
Universidade Federal de Minas Gerais
Belo Horizonte, Minas Gerais, , Brazil
Contact
+55 51 3384 5334

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Ovarian Cancer
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study;

2. Subject is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures;

3. 18 years of age or older;

4. Patient agrees not to participate in another interventional study while on treatment;

5. Histologically diagnosed endometrioid or high-grade serous ovarian cancer, estrogen (ER) and/or progesterone (PR) receptor positive (defined as > 10% by immunohistochemistry);

6. Patients must have completed 2 previous courses of chemotherapy:

1. The penultimate regimen must be a platinum-based chemotherapy course prior to enrolment on the study:

2. For the last chemotherapy course prior to enrolment on the study:

- There is no pre-specified 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 8 weeks of completion of their final dose of second line regimen;

7. Formalin fixed, paraffin embedded tumor sample from the primary tumor must be available for central testing;

8. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;

9. Adequate bone marrow function at screening:

- Absolute Neutrophil Count (ANC) ≥ 1,500/mm³ (≥ 1.5x109/L)

- Platelets ≥ 100,000/mm³ or ≥ 100 x 109/L

- Hemoglobin ≥ 9.0 g/dL;

10. Adequate liver function at screening:

- Total serum bilirubin ≤ 1.5 x upper limit of normal (ULN) (≤ 3.0 x ULN if Gilbert Syndrome)

- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 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);

11. Adequate renal function at screening:

- Serum creatinine ≤ 1.5 x ULN or estimated creatinine clearance ≥ 50mL/min;

12. Evidence of non-childbearing potential:

- Postmenopausal (defined as at least 1 year without any menses) prior to screening, or

- Radiation-induced oophorectomy with last menses >1 year ago, or

- Surgical sterilisation (bilateral oophorectomy or hysterectomy).

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


1. Patients with a known hypersensitivity to Palbociclib or Letrozole or any of the
excipients of the product;


2. Previous treatment with CDK inhibitors or endocrine therapy;


3. Persistent toxicities (grade 2 or greater) caused by previous cancer therapy
(excluding alopecia);


4. Patients with second primary cancer, except: adequately treated non-melanoma skin
cancer, curatively treated in-situ cancer of the cervix, Ductal Carcinoma in Situ
(DCIS), stage 1 grade 1 endometrial carcinoma curatively treated with no evidence of
disease for 3 years;


5. Patients receiving any chemotherapy, radiotherapy, within 3 weeks from the last dose
prior to study entry;


6. Patients with symptomatic uncontrolled brain metastases. A scan to confirm the absence
of brain metastases is not required;


7. Major surgical procedure within 3 weeks prior to study randomization, or one is
planned during the course of the study;


8. 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 6 months)
myocardial infarction, cerebrovascular accident, gastrointestinal bleeding, or any
psychiatric disorder that prohibits obtaining informed consent;


9. 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);


10. Patients have received potent inhibitors or inducers of CYP3A4 within 7 days prior to
randomization;


11. Pregnant or breast feeding women;


12. Patient has a known history of positive test for human immunodeficiency virus (HIV);


13. Patients with known hepatic disease (ie, Hepatitis B or C);


14. 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;


15. Treatment with any investigational product during the last 28 days;


16. QTc > 480ms, QT syndrome, Brugada syndrome, history QTc prolongation or Torsade de
Points;


17. 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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Palbociclib Plus Letrozole Treatment After Progression to Second Line Chemotherapy for Women With ER/PR-positive Ovarian Cancer.
Official Title  ICMJE Palbociclib Plus Letrozole Treatment After Progression to Second Line Chemotherapy for Women With ER/PR-positive Ovarian Cancer.
Brief Summary 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.
Detailed Description

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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Ovarian Cancer
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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).
Interventions:
  • Drug: Palbociclib 125mg
  • Drug: Letrozole 2.5mg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 2, 2019)
39
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 4, 2023
Estimated Primary Completion Date April 4, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study;
  2. Subject is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures;
  3. 18 years of age or older;
  4. Patient agrees not to participate in another interventional study while on treatment;
  5. Histologically diagnosed endometrioid or high-grade serous ovarian cancer, estrogen (ER) and/or progesterone (PR) receptor positive (defined as > 10% by immunohistochemistry);
  6. Patients must have completed 2 previous courses of chemotherapy:

    1. The penultimate regimen must be a platinum-based chemotherapy course prior to enrolment on the study:
    2. For the last chemotherapy course prior to enrolment on the study:

      • There is no pre-specified 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 8 weeks of completion of their final dose of second line regimen;
  7. Formalin fixed, paraffin embedded tumor sample from the primary tumor must be available for central testing;
  8. Eastern Cooperative Oncology Group (ECOG) performance status ? 2;
  9. Adequate bone marrow function at screening:

    • Absolute Neutrophil Count (ANC) ? 1,500/mm³ (? 1.5x109/L)
    • Platelets ? 100,000/mm³ or ? 100 x 109/L
    • Hemoglobin ? 9.0 g/dL;
  10. Adequate liver function at screening:

    • Total serum bilirubin ? 1.5 x upper limit of normal (ULN) (? 3.0 x ULN if Gilbert Syndrome)
    • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ? 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);
  11. Adequate renal function at screening:

    - Serum creatinine ? 1.5 x ULN or estimated creatinine clearance ? 50mL/min;

  12. Evidence of non-childbearing potential:

    • Postmenopausal (defined as at least 1 year without any menses) prior to screening, or
    • Radiation-induced oophorectomy with last menses >1 year ago, or
    • Surgical sterilisation (bilateral oophorectomy or hysterectomy).

Exclusion Criteria:

  1. Patients with a known hypersensitivity to Palbociclib or Letrozole or any of the excipients of the product;
  2. Previous treatment with CDK inhibitors or endocrine therapy;
  3. Persistent toxicities (grade 2 or greater) caused by previous cancer therapy (excluding alopecia);
  4. Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, Ductal Carcinoma in Situ (DCIS), stage 1 grade 1 endometrial carcinoma curatively treated with no evidence of disease for 3 years;
  5. Patients receiving any chemotherapy, radiotherapy, within 3 weeks from the last dose prior to study entry;
  6. Patients with symptomatic uncontrolled brain metastases. A scan to confirm the absence of brain metastases is not required;
  7. Major surgical procedure within 3 weeks prior to study randomization, or one is planned during the course of the study;
  8. 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 6 months) myocardial infarction, cerebrovascular accident, gastrointestinal bleeding, or any psychiatric disorder that prohibits obtaining informed consent;
  9. 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);
  10. Patients have received potent inhibitors or inducers of CYP3A4 within 7 days prior to randomization;
  11. Pregnant or breast feeding women;
  12. Patient has a known history of positive test for human immunodeficiency virus (HIV);
  13. Patients with known hepatic disease (ie, Hepatitis B or C);
  14. 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;
  15. Treatment with any investigational product during the last 28 days;
  16. QTc > 480ms, QT syndrome, Brugada syndrome, history QTc prolongation or Torsade de Points;
  17. 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.
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Laura Voelcker+55 51 3384 5334[email protected]
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03936270
Other Study ID Numbers  ICMJE LACOG 1018
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:Undecided
Responsible Party Latin American Cooperative Oncology Group
Study Sponsor  ICMJE Latin American Cooperative Oncology Group
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Director:Gustavo Werutsky, MDLatin American Cooperative Oncology Group
PRS Account Latin American Cooperative Oncology Group
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP