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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01685255
Recruitment Status : Terminated (Study was terminated by the sponsor for lack of evidence of superiority and slow study accrual.)
First Posted : September 14, 2012
Last Update Posted : March 26, 2018
Information provided by (Responsible Party):
Incyte Corporation

Brief 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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Genitourinary (GU) Tumors Drug: INCB024360 Drug: tamoxifen Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 83 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-Label, Phase 2 Study of the IDO Inhibitor INCB024360 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
Study Start Date : August 2012
Actual Primary Completion Date : October 23, 2014
Actual Study Completion Date : October 23, 2014

Arm Intervention/treatment
Active Comparator: INCB024360
Subjects randomized to Arm A (INCB024360) will take INCB024360 tablets at a dose of 600 mg BID, beginning on Day 1.
Drug: 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

Primary Outcome Measures :
  1. 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. ]

Secondary Outcome Measures :
  1. Safety and tolerability of INCB024360 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. ]
  2. 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. ]
  3. 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. ]
  4. 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. ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01685255

  Hide Study Locations
United States, California
La Jolla, California, United States
Los Angeles, California, United States
San Francisco, California, United States
United States, Illinois
Evanston, Illinois, United States
Joliet, Illinois, United States
United States, Iowa
Iowa City, Iowa, United States
United States, Louisiana
Covington, Louisiana, United States
United States, Maryland
Baltimore, Maryland, United States
United States, Michigan
Detroit, Michigan, United States
United States, Minnesota
Minneapolis, Minnesota, United States
United States, New York
Bridgewater, New York, United States
Buffalo, New York, United States
Mineola, New York, United States
United States, North Carolina
Durham, North Carolina, United States
United States, Pennsylvania
Abington, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
United States, South Carolina
Greenville, South Carolina, United States
Bendigo, Australia
Heidelberg, Australia
Herston, Australia
Milton, Australia
Randwick, Australia
Canada, Alberta
Calgary, Alberta, Canada
Canada, Ontario
Toronto, Ontario, Canada
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
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
Sponsors and Collaborators
Incyte Corporation
Study Director: Lance Leopold, M.D. Incyte Corporation

Responsible Party: Incyte Corporation Identifier: NCT01685255     History of Changes
Other Study ID Numbers: INCB 24360-210
First Posted: September 14, 2012    Key Record Dates
Last Update Posted: March 26, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Incyte Corporation:
increasing CA 125

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents