A Phase 2 Study of the IDO Inhibitor Epacadostat Versus Tamoxifen for Subjects With Biochemical-recurrent-only EOC, PPC or FTC Following Complete Remission With First-line Chemotherapy

March 6, 2019 updated by: Incyte Corporation

A Randomized, Open-Label, Phase 2 Study of the IDO Inhibitor Epacadostat Versus Tamoxifen for Subjects With Biochemical-Recurrent-Only Epithelial Ovarian Cancer, Primary Peritoneal Carcinoma, or Fallopian Tube Cancer Following Complete Remission With First-Line Chemotherapy

This is an open-label, randomized, phase 2 study of an IDO inhibitor, INCB024360 (epacadostat) versus tamoxifen in biochemical recurrent only ovarian cancer patients following complete remission with first-line chemotherapy.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

83

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Bendigo, Australia
      • Heidelberg, Australia
      • Herston, Australia
      • Milton, Australia
      • Randwick, Australia
  • Canada
    • Alberta
      • Calgary, Alberta, Canada
    • Ontario
      • Toronto, Ontario, Canada
    • Quebec
      • Montreal, Quebec, Canada
  • Russian Federation
      • Ekaterinburg, Russian Federation
      • Izhevsk, Russian Federation
      • Krasnodar, Russian Federation
      • Kursk, Russian Federation
      • Moscow, Russian Federation
      • Orenburg, Russian Federation
      • St. Petersburg, Russian Federation
      • Ufa, Russian Federation
  • Ukraine
      • Chernivtsi, Ukraine
      • Dnepropetrovsk, Ukraine
      • Kharkiv, Ukraine
      • Lutsk, Ukraine
  • United Kingdom
      • Bebington, United Kingdom
      • Cardiff, United Kingdom
      • Edinburgh, United Kingdom
      • Glasgow, United Kingdom
      • Keighley, United Kingdom
      • Leeds, United Kingdom
      • Liverpool, United Kingdom
      • London, United Kingdom
      • Manchester, United Kingdom
      • Nottingham, United Kingdom
      • Oxford, United Kingdom
      • West Midlands, United Kingdom
  • United States
    • California
      • La Jolla, California, United States
      • Los Angeles, California, United States
      • San Francisco, California, United States
    • Illinois
      • Evanston, Illinois, United States
      • Joliet, Illinois, United States
    • Iowa
      • Iowa City, Iowa, United States
    • Louisiana
      • Covington, Louisiana, United States
    • Maryland
      • Baltimore, Maryland, United States
    • Michigan
      • Detroit, Michigan, United States
    • Minnesota
      • Minneapolis, Minnesota, United States
    • New York
      • Bridgewater, New York, United States
      • Buffalo, New York, United States
      • Mineola, New York, United States
    • North Carolina
      • Durham, North Carolina, United States
    • Pennsylvania
      • Abington, Pennsylvania, United States
      • Philadelphia, Pennsylvania, United States
    • South Carolina
      • Greenville, South Carolina, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Subjects who have received first-line chemotherapy, which must have been a platinum-containing regimen.
  • Subjects who received maintenance paclitaxel or, bevacizumab, or alternative maintenance therapy (e.g. vaccines) are eligible for enrollment provided they have discontinued therapy at least 4 weeks for prior taxane and, at least 8 weeks for bevacizumab, or received medical monitor approval for time lapse from alternative maintenance therapy prior to randomization and recovered from toxicities to less than Grade 2.

  • Subject must be currently in remission by clinical and radiological criteria (Response Evaluation Criteria for Solid Tumors [RECIST 1.1]).

    a. If a PET scan or high-resolution CT scan is performed and demonstrates new disease </= 1 cm, these subjects would be eligible.

  • Clinical remission is defined as: asymptomatic and a negative physical examination.
  • Scans are required post completion of platinum-containing therapy to document disease remission.

  • Prior to the first-line regimen, CA 125 must have been elevated at first diagnosis, must have normalized with the first-line therapy/regimen, and is currently elevated:

    a. CA 125 elevation is defined as 2 consecutive measurements that are both above the Upper Limit of Normal (ULN) at least 42 weeks apart, with the second measure showing further increases from the first measurement

    1. If CA 125 is ≥ 2 × ULN the confirmatory value only needs to be 1 week apart.
    2. CA 125 elevation is defined as a value that is at least 2 × ULN on 2 occasions at least 1 week apart (UK ONLY REQUIREMENT).
  • CA 125 elevation must be at least 3 months from completion of first-line platinum-containing regimen.
  • Documentation of at least 1 normal CA 125 level at approximately 3 months during or following first line therapy is required.
  • Subjects must have available archived tumor tissue.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Adequate renal, hepatic, and bone marrow function based on screening laboratory assessments.

Exclusion Criteria:

  • Subjects with any evidence of new disease (> 1 cm) including new ascites as confirmed by imaging.
  • Any other prior antitumor systemic therapy except for first-line chemotherapy associated with previous CA 125 normalization or maintenance paclitaxel, bevacizumab, or alternative maintenance therapy as approved by the medical monitor.
  • Subjects with prior radiotherapy within 3 months of randomization and have not recovered from all radiotherapy-related toxicities, who have received radiation therapy to the chest within 3 months of randomization, or who have a history or radiation pneumonitis.
  • Subjects with protocol-specified active autoimmune processes except vitiligo or thyroiditis.
  • Subjects receiving investigational study drug for any indication, immunological-based treatment for any reason (except completed adjuvant therapy with medical monitor approval), or potent CYP3A4 inducers or inhibitors.
  • Subjects receiving monoamine oxidase inhibitors (MAOIs) within the 21 days prior to screening; subjects who have ever had Serotonin Syndrome (SS) after receiving 1 or more serotonergic drugs.
  • Subjects for whom tamoxifen therapy is contraindicated.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Epacadostat
Subjects randomized to Arm A (epacadostat) will take epacadostat tablets at a dose of 600 mg BID, beginning on Day 1.
Drug: Epacadostat
Other Names:
  • INCB024360
ACTIVE_COMPARATOR: Tamoxifen
Subjects randomized to Arm B (tamoxifen) will take tamoxifen tablets at a dose of 20 mg BID, beginning on Day 1.
Drug: tamoxifen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression free survival (PFS) using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 definition of progression as determined by the investigator.
Time Frame: PFS is defined as the number of days from randomization to the earlier of death or disease progression for up to 36 months.
PFS is defined as the number of days from randomization to the earlier of death or disease progression for up to 36 months.

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety and tolerability of epacadostat by adverse event assessment.
Time Frame: Adverse events assessed every 2 weeks during cycle 1, then every 28 days thereafter until each subject's death or disease progression or for up to 36 months, whichever is longest.
Adverse events assessed every 2 weeks during cycle 1, then every 28 days thereafter until each subject's death or disease progression or for up to 36 months, whichever is longest.
Cancer Antigen (CA) 125 response rate, using Gynaecologic Cancer Intergroup (GCIG) criteria.
Time Frame: CA 125 response rate defined as at least 50% reduction on study as compared to pretreatment sample; pre-treatment sample must be at least 2x ULN and response must be sustained for at least 28 days.
CA 125 response rate defined as at least 50% reduction on study as compared to pretreatment sample; pre-treatment sample must be at least 2x ULN and response must be sustained for at least 28 days.
Duration of overall survival.
Time Frame: Overall survival followed every 12 weeks until last date known to be alive, until subjects withdraw consent or up to 36 months, whichever is longest.
Overall survival followed every 12 weeks until last date known to be alive, until subjects withdraw consent or up to 36 months, whichever is longest.
Progression-free survival using RECIST 1.1 definition of objective progression as determined by the central imaging laboratory.
Time Frame: Progression free survival defined by central imaging lab using RECIST 1.1 assessed at 8 week intervals, retrospectively, until disease progression, death, subject withdraw of consent or up to 36 months, whichever is longest.
Progression free survival defined by central imaging lab using RECIST 1.1 assessed at 8 week intervals, retrospectively, until disease progression, death, subject withdraw of consent or up to 36 months, whichever is longest.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Incyte Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (ACTUAL)

October 23, 2014

Study Completion (ACTUAL)

October 23, 2014

Study Registration Dates

First Submitted

September 4, 2012

First Submitted That Met QC Criteria

September 13, 2012

First Posted (ESTIMATE)

September 14, 2012

Study Record Updates

Last Update Posted (ACTUAL)

March 11, 2019

Last Update Submitted That Met QC Criteria

March 6, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INCB 24360-210

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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