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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01685255




Registration number
NCT01685255
Ethics application status
Date submitted
4/09/2012
Date registered
14/09/2012
Date last updated
11/03/2019

Titles & IDs
Public title
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
Scientific title
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
Secondary ID [1] 0 0
INCB 24360-210
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ovarian Cancer 0 0
Genitourinary (GU) Tumors 0 0
Condition category
Condition code
Cancer 0 0 0 0
Ovarian and primary peritoneal

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Active comparator: Epacadostat - Subjects randomized to Arm A (epacadostat) will take epacadostat tablets at a dose of 600 mg BID, beginning on Day 1.

Active comparator: Tamoxifen - Subjects randomized to Arm B (tamoxifen) will take tamoxifen tablets at a dose of 20 mg BID, beginning on Day 1.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression free survival (PFS) using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 definition of progression as determined by the investigator.
Timepoint [1] 0 0
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 [1] 0 0
Safety and tolerability of epacadostat by adverse event assessment.
Timepoint [1] 0 0
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.
Secondary outcome [2] 0 0
Cancer Antigen (CA) 125 response rate, using Gynaecologic Cancer Intergroup (GCIG) criteria.
Timepoint [2] 0 0
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.
Secondary outcome [3] 0 0
Duration of overall survival.
Timepoint [3] 0 0
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.
Secondary outcome [4] 0 0
Progression-free survival using RECIST 1.1 definition of objective progression as determined by the central imaging laboratory.
Timepoint [4] 0 0
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.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
23/10/2014
Sample size
Target
Accrual to date
Final
83
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Bendigo
Recruitment hospital [2] 0 0
- Heidelberg
Recruitment hospital [3] 0 0
- Herston
Recruitment hospital [4] 0 0
- Milton
Recruitment hospital [5] 0 0
- Randwick
Recruitment postcode(s) [1] 0 0
- Bendigo
Recruitment postcode(s) [2] 0 0
- Heidelberg
Recruitment postcode(s) [3] 0 0
- Herston
Recruitment postcode(s) [4] 0 0
- Milton
Recruitment postcode(s) [5] 0 0
- Randwick
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Illinois
Country [3] 0 0
United States of America
State/province [3] 0 0
Iowa
Country [4] 0 0
United States of America
State/province [4] 0 0
Louisiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
Minnesota
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
North Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Pennsylvania
Country [11] 0 0
United States of America
State/province [11] 0 0
South Carolina
Country [12] 0 0
Canada
State/province [12] 0 0
Alberta
Country [13] 0 0
Canada
State/province [13] 0 0
Ontario
Country [14] 0 0
Canada
State/province [14] 0 0
Quebec
Country [15] 0 0
Russian Federation
State/province [15] 0 0
Ekaterinburg
Country [16] 0 0
Russian Federation
State/province [16] 0 0
Izhevsk
Country [17] 0 0
Russian Federation
State/province [17] 0 0
Krasnodar
Country [18] 0 0
Russian Federation
State/province [18] 0 0
Kursk
Country [19] 0 0
Russian Federation
State/province [19] 0 0
Moscow
Country [20] 0 0
Russian Federation
State/province [20] 0 0
Orenburg
Country [21] 0 0
Russian Federation
State/province [21] 0 0
St. Petersburg
Country [22] 0 0
Russian Federation
State/province [22] 0 0
Ufa
Country [23] 0 0
Ukraine
State/province [23] 0 0
Chernivtsi
Country [24] 0 0
Ukraine
State/province [24] 0 0
Dnepropetrovsk
Country [25] 0 0
Ukraine
State/province [25] 0 0
Kharkiv
Country [26] 0 0
Ukraine
State/province [26] 0 0
Lutsk
Country [27] 0 0
United Kingdom
State/province [27] 0 0
Bebington
Country [28] 0 0
United Kingdom
State/province [28] 0 0
Cardiff
Country [29] 0 0
United Kingdom
State/province [29] 0 0
Edinburgh
Country [30] 0 0
United Kingdom
State/province [30] 0 0
Glasgow
Country [31] 0 0
United Kingdom
State/province [31] 0 0
Keighley
Country [32] 0 0
United Kingdom
State/province [32] 0 0
Leeds
Country [33] 0 0
United Kingdom
State/province [33] 0 0
Liverpool
Country [34] 0 0
United Kingdom
State/province [34] 0 0
London
Country [35] 0 0
United Kingdom
State/province [35] 0 0
Manchester
Country [36] 0 0
United Kingdom
State/province [36] 0 0
Nottingham
Country [37] 0 0
United Kingdom
State/province [37] 0 0
Oxford
Country [38] 0 0
United Kingdom
State/province [38] 0 0
West Midlands

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Incyte Corporation
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/study/NCT01685255
Trial related presentations / publications
Kristeleit R, Davidenko I, Shirinkin V, El-Khouly F, Bondarenko I, Goodheart MJ, Gorbunova V, Penning CA, Shi JG, Liu X, Newton RC, Zhao Y, Maleski J, Leopold L, Schilder RJ. A randomised, open-label, phase 2 study of the IDO1 inhibitor epacadostat (INCB024360) versus tamoxifen as therapy for biochemically recurrent (CA-125 relapse)-only epithelial ovarian cancer, primary peritoneal carcinoma, or fallopian tube cancer. Gynecol Oncol. 2017 Sep;146(3):484-490. doi: 10.1016/j.ygyno.2017.07.005. Epub 2017 Jul 8.
Public notes

Contacts
Principal investigator
Name 0 0
Lance Leopold, M.D.
Address 0 0
Incyte Corporation
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01685255