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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Incyte Corporation
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation
ClinicalTrials.gov Identifier:
NCT01685255
First received: September 4, 2012
Last updated: February 26, 2014
Last verified: February 2014

September 4, 2012
February 26, 2014
August 2012
September 2014   (final data collection date for primary outcome measure)
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. ] [ Designated as safety issue: No ]
Progression free survival (PFS) using 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. ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01685255 on ClinicalTrials.gov Archive Site
  • 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. ] [ Designated as safety issue: Yes ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: Yes ]
  • CA 125 response rate, using 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Biochemical-recurrent Only Epithelial Ovarian Cancer
  • Primary Peritoneal Carcinoma
  • Fallopian Tube Cancer
  • Drug: INCB024360
  • Drug: tamoxifen
  • Active Comparator: INCB024360
    Subjects randomized to Arm A (INCB024360) will take INCB024360 tablets at a dose of 600 mg BID, beginning on Day 1.
    Intervention: 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.
    Intervention: Drug: tamoxifen
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
110
May 2015
September 2014   (final data collection date for primary outcome measure)

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.
Female
18 Years and older
No
Contact: Incyte Corporation Call Center 1.855.463.3463
United States,   Australia,   Canada,   Russian Federation,   Ukraine,   United Kingdom
 
NCT01685255
INCB 24360-210
Yes
Incyte Corporation
Incyte Corporation
Not Provided
Study Director: Lance Leopold, M.D. Incyte Corporation
Incyte Corporation
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP