Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
A database of clinical trials and their results from Australia, New Zealand, and other countries.
account_circle
Log in
to register or update your trial
search
Search for trials
Trial Review
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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT07023627
Registration number
NCT07023627
Ethics application status
Date submitted
9/06/2025
Date registered
17/06/2025
Date last updated
12/09/2025
Titles & IDs
Public title
A Study of INCB123667 in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression
Query!
Scientific title
A Phase 2, Single-Arm Study of INCB123667 in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression
Query!
Secondary ID [1]
0
0
GOG-3129/INCB123667-203
Query!
Secondary ID [2]
0
0
INCB123667-203
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Ovarian Cancer
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Ovarian and primary peritoneal
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - INCB123667
Experimental: Cohort 1 - INCB123667 will be administered at the protocol defined dose based on their tumor cyclin E1 expression levels as defined in the protocol.
Experimental: Cohort 2 - INCB123667 will be administered at the protocol defined dose based on their tumor cyclin E1 expression levels as defined in the protocol.
Experimental: Cohort 3 - INCB123667 will be administered at the protocol defined dose based on their tumor cyclin E1 expression levels as defined in the protocol.
Treatment: Drugs: INCB123667
Administered orally twice daily (BID).
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Objective Response by IRC
Query!
Assessment method [1]
0
0
Defined as having a confirmed best overall response of complete response (CR) or partial response (PR), as determined by independent review committee (IRC) assessment per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Query!
Timepoint [1]
0
0
Up to 2 years
Query!
Secondary outcome [1]
0
0
Duration of Response (DOR) by IRC
Query!
Assessment method [1]
0
0
Defined as the time from the earliest date of CR or PR contributing to a subsequently confirmed CR or PR until the earliest date of disease progression, as determined by IRC assessment per RECIST v1.1, or death due to any cause, whichever occurs first.
Query!
Timepoint [1]
0
0
Up to 2 years
Query!
Secondary outcome [2]
0
0
Progression-Free Survival (PFS) by IRC
Query!
Assessment method [2]
0
0
Defined as the time from the date of first dose of study drug until the earliest date of disease progression as determined by IRC assessment per RECIST v1.1, or death due to any cause, whichever occurs first.
Query!
Timepoint [2]
0
0
Up to 2 years
Query!
Secondary outcome [3]
0
0
Overall Survival (OS)
Query!
Assessment method [3]
0
0
Defined as the time from the date of first dose of study drug until death due to any cause.
Query!
Timepoint [3]
0
0
Up to 2 years
Query!
Secondary outcome [4]
0
0
Objective Response by Investigator
Query!
Assessment method [4]
0
0
Defined as having a confirmed best overall response of CR or PR, as determined by investigator assessment per RECIST v1.1.
Query!
Timepoint [4]
0
0
Up to 2 years
Query!
Secondary outcome [5]
0
0
DOR by investigator
Query!
Assessment method [5]
0
0
Defined as the time from the earliest date of CR or PR contributing to a subsequently confirmed CR or PR until the earliest date of disease progression, as determined by investigator assessment per RECIST v1.1, or death due to any cause, whichever occurs first.
Query!
Timepoint [5]
0
0
Up to 2 years
Query!
Secondary outcome [6]
0
0
PFS by Investigator
Query!
Assessment method [6]
0
0
Defined as the time from the date of first dose of study drug until the earliest date of disease progression, as determined by investigator assessment per RECIST v1.1, or death due to any cause, whichever occurs first.
Query!
Timepoint [6]
0
0
Up to 2 years
Query!
Secondary outcome [7]
0
0
Treatment Emergent Adverse Events (TEAE'S)
Query!
Assessment method [7]
0
0
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug until 30 days after the last dose of study drug or the start of new anticancer therapy, whichever occurs first.
Query!
Timepoint [7]
0
0
Up to 2 years and 30 days
Query!
Secondary outcome [8]
0
0
TEAEs leading to dose interruptions, dose reductions or discontinuation of study treatment
Query!
Assessment method [8]
0
0
TEAEs leading to dose interruptions, dose reductions or discontinuation of study treatment.
Query!
Timepoint [8]
0
0
Up to 2 years and 30 days
Query!
Eligibility
Key inclusion criteria
* Histological diagnosis of a 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 a 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 therapy is considered an appropriate next therapeutic option.
* Must have received bevacizumab unless there was a contraindication for its use.
* If the tumor tests positive for FRa, participants must have received mirvetuximab soravtansine unless there is an exception for its use on medical grounds.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
99
Years
Query!
Query!
Sex
Females
Query!
Can healthy volunteers participate?
No
Query!
Key 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: either did not respond (CR or PR) to first-line platinum-containing therapy or progressed on or within 3 months after the last dose of the first line platinum-containing therapy.
* The tumor tests positive for FRa but the participant has not received mirvetuximab soravtansine for any reason other than medical contraindication.
* Clinically significant or uncontrolled cardiac disease within 6 months before the first dose of study drug.
* Known active CNS metastases and/or carcinomatous meningitis.
* Known additional malignancy that is progressing or requires active treatment.
Other protocol-defined Inclusion/Exclusion Criteria may apply.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Non-randomised trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
30/09/2025
Query!
Actual
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
24/10/2027
Query!
Actual
Query!
Sample size
Target
160
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
NSW,SA,TAS
Query!
Recruitment hospital [1]
0
0
Blacktown Cancer & Haematology Centre-Blacktown Hospital - Blacktown
Query!
Recruitment hospital [2]
0
0
Concord General Repatriation Hospital - Concord
Query!
Recruitment hospital [3]
0
0
Burnside War Memorial Hospital - the Brian Fricker Oncology Centre - Adelaide
Query!
Recruitment hospital [4]
0
0
Hobart Hospital-Royal Hobart Hospital - Hobart
Query!
Recruitment hospital [5]
0
0
Cancer Research Sa (Crsa) - Adelaide
Query!
Recruitment hospital [6]
0
0
Southern Oncology Clinical Research Unit - South Australia
Query!
Recruitment postcode(s) [1]
0
0
02148 - Blacktown
Query!
Recruitment postcode(s) [2]
0
0
02139 - Concord
Query!
Recruitment postcode(s) [3]
0
0
05065 - Adelaide
Query!
Recruitment postcode(s) [4]
0
0
07000 - Hobart
Query!
Recruitment postcode(s) [5]
0
0
05000 - Adelaide
Query!
Recruitment postcode(s) [6]
0
0
05042 - South Australia
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arkansas
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
California
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
District of Columbia
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Florida
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Georgia
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Indiana
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Iowa
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Kentucky
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Louisiana
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Maryland
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Massachusetts
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Michigan
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Minnesota
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Mississippi
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Missouri
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Montana
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Nebraska
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
New Jersey
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
New York
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Ohio
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Pennsylvania
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
South Carolina
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
Texas
Query!
Country [25]
0
0
United States of America
Query!
State/province [25]
0
0
Utah
Query!
Country [26]
0
0
United States of America
Query!
State/province [26]
0
0
Virginia
Query!
Country [27]
0
0
United States of America
Query!
State/province [27]
0
0
West Virginia
Query!
Country [28]
0
0
United States of America
Query!
State/province [28]
0
0
Wisconsin
Query!
Country [29]
0
0
Belgium
Query!
State/province [29]
0
0
Brussels
Query!
Country [30]
0
0
Belgium
Query!
State/province [30]
0
0
Kortrijk
Query!
Country [31]
0
0
Belgium
Query!
State/province [31]
0
0
Leuven
Query!
Country [32]
0
0
Belgium
Query!
State/province [32]
0
0
Liège
Query!
Country [33]
0
0
Japan
Query!
State/province [33]
0
0
Akashi-shi
Query!
Country [34]
0
0
Japan
Query!
State/province [34]
0
0
Hidaka-shi
Query!
Country [35]
0
0
Japan
Query!
State/province [35]
0
0
Kotoku
Query!
Country [36]
0
0
Japan
Query!
State/province [36]
0
0
Kurume
Query!
Country [37]
0
0
Japan
Query!
State/province [37]
0
0
Matsuyama
Query!
Country [38]
0
0
Japan
Query!
State/province [38]
0
0
Sapporo
Query!
Country [39]
0
0
Japan
Query!
State/province [39]
0
0
Sunto-gun
Query!
Country [40]
0
0
Puerto Rico
Query!
State/province [40]
0
0
PR
Query!
Country [41]
0
0
Spain
Query!
State/province [41]
0
0
Barcelona
Query!
Country [42]
0
0
Spain
Query!
State/province [42]
0
0
Girona
Query!
Country [43]
0
0
Spain
Query!
State/province [43]
0
0
Madrid
Query!
Country [44]
0
0
Spain
Query!
State/province [44]
0
0
Murcia
Query!
Country [45]
0
0
Spain
Query!
State/province [45]
0
0
Valencia
Query!
Country [46]
0
0
Switzerland
Query!
State/province [46]
0
0
Bellinzona
Query!
Country [47]
0
0
Switzerland
Query!
State/province [47]
0
0
Chur
Query!
Country [48]
0
0
Switzerland
Query!
State/province [48]
0
0
Geneva
Query!
Country [49]
0
0
Switzerland
Query!
State/province [49]
0
0
Lausanne
Query!
Country [50]
0
0
Switzerland
Query!
State/province [50]
0
0
Liestal
Query!
Country [51]
0
0
Switzerland
Query!
State/province [51]
0
0
Sankt Gallen
Query!
Country [52]
0
0
United Kingdom
Query!
State/province [52]
0
0
Edinburgh
Query!
Country [53]
0
0
United Kingdom
Query!
State/province [53]
0
0
London
Query!
Country [54]
0
0
United Kingdom
Query!
State/province [54]
0
0
Manchester Greater
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Incyte Corporation
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Other
Query!
Name [1]
0
0
GOG Foundation
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
This study will evaluate the safety and efficacy of INCB123667 in Participants With Platinum-Resistant Ovarian Cancer (PROC) With Cyclin E1 Overexpression.
Query!
Trial website
https://clinicaltrials.gov/study/NCT07023627
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Incyte Medical Monitor
Query!
Address
0
0
Incyte Corporation
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Incyte Corporation Call Center (US)
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
1.855.463.3463
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
Query!
When will data be available (start and end dates)?
Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
Query!
Available to whom?
Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
IPD available at link: https://www.incyte.com/our-company/compliance-and-transparency
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT07023627
Download to PDF