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Ovarian CancerPhase 2NCT01685255

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

A Phase 2 study testing Epacadostat and tamoxifen in people with Ovarian Cancer and Genitourinary (GU) Tumors, run by Incyte Corporation at 49 sites in 6 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Cancer, Genitourinary (GU) Tumors
What is being tested?
Epacadostat and tamoxifen
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
83 participants
Where
49 sitesin 6 countries
Study dates
Aug 2012to 23 Oct 2014
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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]).
  • 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.
Show all 15Show fewer
  • 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:
  • 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
  • If CA 125 is ≥ 2 × ULN the confirmatory value only needs to be 1 week apart.
  • 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.

Who cannot join

  • 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 locations and contacts

49 sites in 6 countries.

49 sites in 6 countries

United States17 sites

  • Study site

    Abington, Pennsylvania

  • Study site

    Baltimore, Maryland

  • Study site

    Bridgewater, New York

  • Study site

    Buffalo, New York

  • Study site

    Covington, Louisiana

  • Study site

    Detroit, Michigan

  • Study site

    Durham, North Carolina

  • Study site

    Evanston, Illinois

  • Study site

    Greenville, South Carolina

  • Study site

    Iowa City, Iowa

  • Study site

    Joliet, Illinois

  • Study site

    La Jolla, California

  • Study site

    Los Angeles, California

  • Study site

    Mineola, New York

  • Study site

    Minneapolis, Minnesota

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    San Francisco, California

Other trials in United States

United Kingdom12 sites

  • Study site

    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

Other trials in United Kingdom

Russia8 sites

  • Study site

    Izhevsk

  • Study site

    Krasnodar

  • Study site

    Kursk

  • Study site

    Moscow

  • Study site

    Orenburg

  • Study site

    Saint Petersburg

  • Study site

    Ufa

  • Study site

    Yekaterinburg

Other trials in Russia

Australia5 sites

  • Study site

    Bendigo

  • Study site

    Heidelberg

  • Study site

    Herston

  • Study site

    Milton

  • Study site

    Randwick

Other trials in Australia

Ukraine4 sites

  • Study site

    Chernivtsi

  • Study site

    Dnipro

  • Study site

    Kharkiv

  • Study site

    Lutsk

Other trials in Ukraine

Canada3 sites

  • Study site

    Calgary, Alberta

  • Study site

    Montreal, Quebec

  • Study site

    Toronto, Ontario

Other trials in Canada

About this study

Official 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

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.

Being tested
Epacadostat, tamoxifen
Keywords
FIGO Stage III or IV EOC, PPC FTC, increasing CA 125
Medical subject headings
Ovarian Neoplasms, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EpacadostatDrug

    Also called INCB024360

  • tamoxifenDrug

Study groups in NCT01685255
Study groupRoleWhat they receive
EpacadostatActive comparatorSubjects randomized to Arm A (epacadostat) will take epacadostat tablets at a dose of 600 mg BID, beginning on Day 1.
Receives: Drug: Epacadostat
TamoxifenActive comparatorSubjects randomized to Arm B (tamoxifen) will take tamoxifen tablets at a dose of 20 mg BID, beginning on Day 1.
Receives: Drug: tamoxifen

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression free survival (PFS) using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 definition of progression as determined by the investigator.

    Measured: PFS is defined as the number of days from randomization to the earlier of death or disease progression for up to 36 months.

Secondary outcomes (4)

  1. Safety and tolerability of epacadostat by adverse event assessment.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2012 (estimated)
  2. Study startAug 2012
  3. Primary completion23 Oct 2014
  4. Study completion23 Oct 2014

Why it stopped: Study was terminated by the sponsor for lack of evidence of superiority and slow study accrual.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
83 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01685255
Sponsor's protocol ID
INCB 24360-210
Status last verified
Mar 2019
First submitted
4 Sep 2012
Last updated
11 Mar 2019
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

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.

    PubMed 28698009

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Epacadostat and tamoxifen in people with Ovarian Cancer and Genitourinary (GU) Tumors, run by Incyte Corporation at 49 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 11 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 49 sites in United States, United Kingdom, Russia, Australia, Ukraine and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Study was terminated by the sponsor for lack of evidence of superiority and slow study accrual.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01685255, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2019.

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