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Ovarian CancerPhase 2NCT03936270

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

A Phase 2 study testing Palbociclib 125mg and Letrozole 2.5mg in people with Ovarian Cancer, run by Latin American Cooperative Oncology Group at 5 sites in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
Palbociclib 125mg and Letrozole 2.5mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
43 participants
Where
5 sitesBrazil
Study dates
5 Mar 2020to 2 May 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
  • 18 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;
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  • 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)
  • Plates ≥ 100,000/mm3 or ≥ 100 x 109/L
  • Hemoglobin ≥ 9.0 g/dL;
  • 12. Adequate liver function:
  • Total serum bilirubin ≤ 1.5 x upper limit of normal (ULN) (≤ 3.0 x ULN if there is Gilbert's Syndrome)
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x ULN (≤ 5.0 x ULN if liver tumor was involved)
  • Alkaline phosphatase ≤ 2.5 x ULN (≤ 5.0 x ULN if any liver tumor involvement); 13. Adequate kidney function:
  • Estimated creatinine clearance ≥ 15 mL/min; 14. Evidence of lack of potential to become pregnant:
  • Post-menopause (defined as at least 1 year without menstruation) before selection, or
  • Radiotherapy-induced oophorectomy with the last menstruation > 1 year ago, or
  • Surgical sterilization (bilateral oophorectomy or hysterectomy).

Who cannot join

  • 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;
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  • 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;
  • Other acute or chronic medical or psychiatric condition or severe laboratory abnormality that could increase the risk associated with participation in the study or that could interfere with the interpretation of the study results and, in the investigator's judgment, would make the research participant unsuitable for entry into this study.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Brazil5 sites

  • UFMG - Universidade Federal de Minas Gerais

    Belo Horizonte, Minas Gerais, 30.130-100

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

    Porto Alegre, Rio Grande do Sul, 90.610-000

  • INCA - Instituto Nacional de Câncer

    Rio de Janeiro, 20.230-130

  • ICESP - Instituto do Câncer do Estado de São Paulo

    São Paulo, 01.246-000

  • BP - A Beneficência Portuguesa de São Paulo

    São Paulo, 01.323-030

Other trials in Brazil

About this study

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.

Read the 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.

Conditions
Ovarian Cancer
Being tested
Palbociclib 125mg, Letrozole 2.5mg
Keywords
Palbociclib, Letrozole, Ovarian Cancer
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Palbociclib 125mgDrug

    Also called Ibrance®

    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.

  • Letrozole 2.5mgDrug

    Also called Femara

    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.

Study groups in NCT03936270
Study groupRoleWhat they receive
Palbociclib 125mg + Letrozole 2.5mgExperimentalPalbociclib 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).
Receives: Drug: Palbociclib 125mg; Drug: Letrozole 2.5mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 weeks

Secondary outcomes (8)

  1. Overall response

    defined as the proportion of patients who have a partial or complete response to therapy according to RECIST 1.1

    Measured: 2 years

  2. Overall Survival

    Overall Survival at year 1 and 2

    Measured: 2 years

  3. Clinical Benefit Rate

    defined as the proportion of patients who have achieved complete response, partial response and stable disease for at least 24 weeks.

    Measured: 2 years

  4. Duration of response

    defined as the time from response to progression by RECIST v11.1 or death

    Measured: 2 years

  5. CA-125 response (GCIG criteria)

    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)

    Measured: 2 years

  6. Time to progression by CA-125 (GCIG criteria) or RECIST

    defined as the time from response to progression by CA 125 (GCIG criteria) or RECIST

    Measured: 2 years

  7. Quality of Life (FACT-O questionnaire)

    assessed using the FACT-O questionnaire

    Measured: 2 years

  8. Safety (adverse events)

    defined as the proportion of patients who present adverse events

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2019
  2. Study start5 Mar 2020
  3. Primary completion18 Jan 2022
  4. Study completion2 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03936270
Sponsor's protocol ID
LACOG 1018
Status last verified
Feb 2024
First submitted
5 Feb 2019
Last updated
20 Feb 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Palbociclib 125mg and Letrozole 2.5mg in people with Ovarian Cancer, run by Latin American Cooperative Oncology Group at 5 sites in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Twelve weeks of Progression Free Survival (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03936270.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.

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