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

NCT03936270 | Completed Phase 2

• 1 other identifier: LACOG 1018
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 5

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.

Conditions

Ovarian Cancer

Keywords

Palbociclib; Letrozole; Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• Twelve weeks of Progression Free Survival

  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.

  12 weeks

Secondary Outcomes (8)

• Overall response

  2 years

• Overall Survival

  2 years

• Clinical Benefit Rate

  2 years

• Duration of response

  2 years

• CA-125 response (GCIG criteria)

  2 years

Study Arms (1)

Palbociclib 125mg + Letrozole 2.5mg

EXPERIMENTAL

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; Drug: Letrozole 2.5mg

Interventions

Palbociclib 125mg DRUG

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.

Also known as: Ibrance®

Palbociclib 125mg + Letrozole 2.5mg

Letrozole 2.5mg DRUG

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.

Also known as: Femara

Palbociclib 125mg + Letrozole 2.5mg

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• years of age or older;
• Patient agrees not to participate in another interventional study while on treatment;
• Histology confirmed ovarian cancer serous or endometrioid high degree, fallopian tube or with locoregional recurrence peritoneum (not amenable to curative treatment) or metastatic;
• Estrogen (ER) and/or progesterone (RP) receptor positive tumor, defined as \> 10% by immunohistochemical examination in the local laboratory;
• Availability of tumor sample from the primary tumor or metastasis, fixed in formalin and embedded in paraffin, for confirmation of positivity for ER and/or RP in a central laboratory;
• Disease measurable by RECIST 1.1 as assessed by the local investigator or radiologist;
• Patients must have chemotherapy application for recurrence locoregional or metastatic according to the following criteria:
• at least one platinum-based chemotherapy regimen;
• have confirmed no more than 3 chemotherapy regimens for locally advanced or metastatic disease
• Patient must have radiographic disease progression to last treatment;
• Functional capacity by the Eastern Cooperative Oncology Group (ECOG) ≤ 2;
• Adequate bone marrow function:
• Absolute neutrophil count (CAN) ≥ 1,500/mm3 (≥ 1.5x109/L)

You may not qualify if:

• Patients with a known hypersensitivity to Palbociclib or Letrozole or any of the excipients of the product;
• Previous treatment with CDK4/6 inhibitors or endocrine therapy;
• Disease progression during or within 6 months of the first platinum-based chemotherapy regimen.
• Persistent toxicities (Grade 2 or higher) caused by previous anticancer therapy (excluding alopecia);
• Patients with a second primary cancer, except: adequately treated non-melanoma skin cancer, cervical cancer in situ curatively treated, Ductal carcinoma in situ (DCIS), stage 1 grade 1 endometrial carcinoma curatively treated with no evidence of illness for 3 years;
• Last dose of chemotherapy or radiotherapy within 3 weeks of study enrollment;
• Patients with symptomatic uncontrolled brain metastases. An exam to confirm the absence of brain metastases is not necessary;
• Major surgical procedure within 3 weeks prior to study randomization, or planned during the course of the study;
• Patients considered a precarious medical risk due to a disorder uncontrolled serious medical, non-malignant systemic disease, or uncontrolled active infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent myocardial infarction (within 6 months), stroke, gastrointestinal bleeding, or any psychiatric disorder that precludes informed consent;
• Patients who have difficulty taking oral medication or any digestive tract dysfunction or inflammatory bowel disease that interferes with intestinal absorption of medications (eg, partial bowel obstruction or malabsorption);
• Patients received potent inhibitors or inducers of CYP3A4 within 7 days of randomization;
• Pregnant or nursing women;
• The patient has a known history of testing positive for human immunodeficiency virus (HIV);
• Patients with known liver disease (ie, Hepatitis B or C);
• Treatment with any product under investigation during the last 28 days;

Sponsors & Collaborators

• Latin American Cooperative Oncology Group: lead
• Pfizer: collaborator

Study Sites (5)

UFMG - Universidade Federal de Minas Gerais

Belo Horizonte, Minas Gerais, 30.130-100, Brazil

Location

CPO - Centro de Pesquisa em Oncologia do Hospital São Lucas da PUCRS

Porto Alegre, Rio Grande do Sul, 90.610-000, Brazil

Location

INCA - Instituto Nacional de Câncer

Rio de Janeiro, 20.230-130, Brazil

Location

ICESP - Instituto do Câncer do Estado de São Paulo

São Paulo, 01.246-000, Brazil

Location

BP - A Beneficência Portuguesa de São Paulo

São Paulo, 01.323-030, Brazil

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

palbociclib; Letrozole

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Fernanda Bronzon Damian

  Latin American Cooperative Oncology Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2019
• First Posted: May 3, 2019
• Study Start: March 5, 2020
• Primary Completion: January 18, 2022
• Study Completion: May 2, 2023
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (5)