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Looking for participantsPhase3

Study to Evaluate INCB123667 Versus Investigator's Choice of Chemotherapy in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression

Sponsor: Incyte Corporation

NCT ID: NCT07214779

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
INCB123667 (drug), Investigator's choice of chemotherapy (drug)
How long the study runs
Study runs about 41 months (dates as stated)
About the drug or intervention
INCB123667 — drug: Oral; tablet · Investigator's choice of chemotherapy — drug: The investigator will select the chemotherapy in accordance with the protocol-defined requirements.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
Female
Number of participants
466
Started
2025-12-09
Last checked
2026-10

Plain English Summary

What is this study?

  • • Testing a new treatment for ovarian cancer
  • • Phase3 - 466 participants
  • • The purpose of this study is to evaluate INCB123667 versus investigator's choice of chemotherapy in participants with platinum-resistant ovarian cancer with cyclin E1 overexpression

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with ovarian cancer
  • • Female only

Where?

  • • Cambridge - Addenbrooke'S Hospital - Cambridge University Hospitals Nhs Foundation Trust
  • • Cardiff - Velindre Nhs Trust, Velindre Cancer Centre
  • • Guildford - Royal Surrey County Hospital - Royal Surrey County Hospital Nhs Foundation Trust
  • • Leeds - St James'S University Hospital - Leeds Teaching Hospitals Nhs Trust
  • • +9 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

The purpose of this study is to evaluate INCB123667 versus investigator's choice of chemotherapy in participants with platinum-resistant ovarian cancer with cyclin E1 overexpression.

Ovarian Cancer

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: Female only

Biomarkers mentioned

tumor is positive

Treatment history

Treatments you must have had:

  • ✓ received at least 4 cycles of platinum containing regimen
  • ✓ progressed on or within 6 months after the last dose of platinum
  • ✓ bevacizumab unless there was a contraindication f
  • ✓ mirvetuximab s

What the study is looking for

  • ✓Histological diagnosis of high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer.
  • ✓Have platinum-resistant disease.
  • ✓Participants who have only had 1 line of platinum-based therapy must have received at least 4 cycles of platinum...
  • ✓Participants who have received 2 to 4 lines of platinum-based therapy must have progressed on or within 6 months...
  • ✓Archival FFPE tumor tissue block or slides from a specimen no older than 5 years must be available. If not...

Who cannot take part

  • ✗Have endometrioid, clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of these histologies,...
  • ✗Have primary platinum-refractory disease, defined as progression on or within 3 months after the last dose of first...
  • ✗Clinically significant or uncontrolled heart disease within 6 months before the first dose of study treatment.
  • ✗Known active CNS metastases and/or carcinomatous meningitis.
  • ✗Known additional cancer that is progressing or requires active treatment, or history of other cancer within...
See the full criteria
Inclusion Criteria: * Histological diagnosis of high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer. * Have platinum-resistant disease. * Participants who have only had 1 line of platinum-based therapy must have received at least 4 cycles of platinum containing regimen. * Participants who have received 2 to 4 lines of platinum-based therapy must have progressed on or within 6 months after the last dose of platinum. * Archival FFPE tumor tissue block or slides from a specimen no older than 5 years must be available. If not available, participant must be willing to undergo a pretreatment tumor biopsy. * Received at least 1 and no more than 4 prior lines of systemic therapy following the initial diagnosis, after which single-agent chemotherapy is considered an appropriate next therapeutic option. * Should have received prior treatment with bevacizumab unless there was a contraindication for its use. * Should have received prior treatment with mirvetuximab soravtansine if the tumor is positive for FRα, unless there is an exception for its use on medical grounds. * Measurable disease per RECIST v1.1. Exclusion Criteria: * Have endometrioid, clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of these histologies, or low-grade/borderline ovarian cancer. * Have primary platinum-refractory disease, defined as progression on or within 3 months after the last dose of first line platinum-containing therapy. * Clinically significant or uncontrolled cardiac disease within 6 months before the first dose of study treatment. * Known active CNS metastases and/or carcinomatous meningitis. * Known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 3 years before the first dose of study treatment. * Clinically significant gastrointestinal abnormalities. Other protocol-defined Inclusion/Exclusion Criteria may apply.

Where Is This Study? (13 UK sites)

Addenbrooke'S Hospital - Cambridge University Hospitals Nhs Foundation Trust

Cambridge CB2 0QQ, United Kingdom

Recruiting
Hospital R&D contact (matched)

Stephen Kelleher

cuh.research@nhs.net01223 348490

Velindre Nhs Trust, Velindre Cancer Centre

Cardiff CF14 2TL, United Kingdom

COMPLETED
Hospital R&D contact (matched)

Sarah Townsend

Velindre.R&Doffice@wales.nhs.uk02920 196165

Royal Surrey County Hospital - Royal Surrey County Hospital Nhs Foundation Trust

Guildford GU2 7XX, United Kingdom

Recruiting
Hospital R&D contact (matched)

Stephen Barnett

rsc-tr.ResearchAndDevelopment@nhs.net01483 688600

St James'S University Hospital - Leeds Teaching Hospitals Nhs Trust

Leeds LS9 7TF, United Kingdom

Recruiting
Hospital R&D contact (matched)

R&I Team

leedsth-tr.researchfacilitation@nhs.net0113 2060469

Clatterbridge Cancer Center

Liverpool L7 8YA, United Kingdom

Recruiting
Hospital R&D contact (matched)

Dr Maria Maguire

maria.maguire2@nhs.net0151 556 5321

University College London Hospitals - University College London Hospitals Nhs Foundation Trust

London NW1 2BU, United Kingdom

Recruiting
Hospital R&D contact (matched)

Rajinder Sidhu - Associate Director, Research Governance and Operations

uclh.jro-communications@nhs.net020 3447 9825

Guy'S Hospital - Guy'S & St Thomas' Nhs Foundation Trust

London SE1 9RT, United Kingdom

Recruiting
Hospital R&D contact (matched)

Main Email: gstt.RandD@nhs.net

gstt.RandD@nhs.net---

Royal Marsden Hospital - London

London SW3 6JJ, United Kingdom

Recruiting
Hospital R&D contact (matched)

Mark Brandon-Grove

research.development@rmh.nhs.uk020 3186 5416

The Christie Nhs Foundation Trust

Manchester Greater M204BX, United Kingdom

Recruiting
Hospital R&D contact (matched)

Research and Innovation Office

the-christie.ri@nhs.net---

Northampton General Hospital - Northampton General Hospital Nhs Trust

Northampton NN1 5BD, United Kingdom

Recruiting
Hospital R&D contact (matched)

Michelle Spinks, Head of Research

ngh-tr.research.unit@nhs.net01604 545941

Mount Vernon Cancer Centre

Northwood HA6 2RN, United Kingdom

NOT_YET_RECRUITING

Royal Marsden Hospital - Sutton

Sutton SM2 5PT, United Kingdom

Recruiting
Hospital R&D contact (matched)

Mark Brandon-Grove

research.development@rmh.nhs.uk020 3186 5416

Musgrove Park Hospital - Somerset Nhs Foundation Trust

Taunton TA1 5DA, United Kingdom

Recruiting
Hospital R&D contact (matched)

Karen Tanner

Research@somersetft.nhs.uk01935 384559

How to Get in Touch

Incyte Corporation Call Center (US)

Sponsor contact

CONTACT

1.855.463.3463 medinfo@incyte.com

Incyte Corporation Call Center (ex-US)

Sponsor contact

CONTACT

+800 00027423 eumedinfo@incyte.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-10