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Clinical Trials (PDQ®)

A Phase 2 Study of the IDO Inhibitor INCB024360 Versus Tamoxifen for Subjects With Biochemical-recurrent-only EOC, PPC or FTC Following Complete Remission With First-line Chemotherapy

Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IITreatmentActive18 and overPharmaceutical / IndustryINCB 24360-210
NCT01685255

Trial Description

Summary

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

Eligibility Criteria

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.

Trial Contact Information

Trial Lead Organizations/Sponsors

Incyte Corporation

Lance H. LeopoldStudy Director

Incyte Corporation Call CenterPh: 1.855.463.3463

Trial Sites

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

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01685255
ClinicalTrials.gov processed this data on February 27, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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