Breast CancerPhase 1/2NCT01254136
Safety and Efficacy of INCB007839 With Trastuzumab and Vinorelbine in Patients With Metastatic HER2+ Breast Cancer
A Phase 1/2 study testing INCB007839 300mg BID, Trastuzumab and Vinorelbine in people with Breast Cancer, run by Incyte Corporation at 14 sites in United States.
Trial summary
This Phase I/II study is designed to assess the safety and therapeutic effect of INCB007839 in combination with trastuzumab and vinorelbine in patients with metastatic HER2+ breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- INCB007839 300mg BID, Trastuzumab and Vinorelbine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 14 sitesUnited States
- Study dates
- Oct 2010to Oct 2011
- Phase
- Phase 1/2
- 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
- Subject with diagnosis of metastatic (or locally recurrent-inoperable) breast cancer
- Subject with histological HER2+ status as determined by FISH with a gene amplification score of ≥ 2.2
- Subject with availability of archival biopsy tissue from primary tumor or metastatic lesions
- Subject with presence of measurable disease based on RECIST 1.1
- Subject who has received no more than three prior HER2-directed therapeutic regimens for advanced breast cancer
Who cannot join
- Subject with Left ventricular ejection fraction (LVEF) below institutional normal range
- Subject with metastasis to the central nervous system UNLESS asymptomatic and clinically stable
- Subject with current active malignancy other than breast cancer
- Subject with prior history of other malignancy except for cancers from which the patient is currently disease free
- Subject with significant renal or hepatic dysfunction
- Subject with history of venous or arterial thrombosis or risk factor for thrombosis other than history of malignancy
Show all 9Show fewer
- Subject with insufficient bone marrow function
- Subject with contraindication to vinorelbine, trastuzumab, aspirin and/or warfarin therapy.
- Subject with current active bacterial, Hepatitis B or C, and/or HIV infections
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Study site
Cincinnati, Ohio
Study site
Davie, Florida
Study site
Denver, Colorado
Study site
Detroit, Michigan
Study site
Duarte, California
Study site
Fayetteville, Arkansas
Study site
Hackensack, New Jersey
Study site
Huntersville, North Carolina
Study site
Jacksonville, Florida
Study site
Lake Success, New York
Study site
Nashville, Tennessee
Study site
Philadelphia, Pennsylvania
Study site
Salt Lake City, Utah
Study site
St Louis, Missouri
About this study
Official title: A Phase I/II Study to Assess the Safety and Therapeutic Effect of INCB007839 in Combination With Trastuzumab and Vinorelbine in Patients With Metastatic HER2+ Breast Cancer.
This Phase I/II study is designed to assess the safety and therapeutic effect of INCB007839 in combination with trastuzumab and vinorelbine in patients with metastatic HER2+ breast cancer.
- Conditions
- Breast Cancer
- Being tested
- INCB007839 300mg BID, Trastuzumab, Vinorelbine
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INCB007839 300mg BIDDrug
INCB007839 tablets (300 mg BID) in combination with trastuzumab and vinorelbine will be administered in an initial Cycle of 28 days and followed by continuous 21-day cycles subsequently. Trastuzumab will be administered in continuous 21-day cycles beginning on Day 8 of Cycle 1. Vinorelbine will be administered on a weekly schedule for a minimum of the first four cycles beginning on Cycle 1 Day 8. All drugs will be administered continuously as tolerated or until a protocol-defined stopping criteria is met.
TrastuzumabDrug
INCB007839 tablets (300 mg BID) in combination with trastuzumab and vinorelbine will be administered in an initial Cycle of 28 days and followed by continuous 21-day cycles subsequently. Trastuzumab will be administered in continuous 21-day cycles beginning on Day 8 of Cycle 1. Vinorelbine will be administered on a weekly schedule for a minimum of the first four cycles beginning on Cycle 1 Day 8. All drugs will be administered continuously as tolerated or until a protocol-defined stopping criteria is met.
VinorelbineDrug
INCB007839 tablets (300 mg BID) in combination with trastuzumab and vinorelbine will be administered in an initial Cycle of 28 days and followed by continuous 21-day cycles subsequently. Trastuzumab will be administered in continuous 21-day cycles beginning on Day 8 of Cycle 1. Vinorelbine will be administered on a weekly schedule for a minimum of the first four cycles beginning on Cycle 1 Day 8. All drugs will be administered continuously as tolerated or until a protocol-defined stopping criteria is met.
| Study group | Role | What they receive |
|---|---|---|
| Treatment A - INCB007839 300mg BID | Experimental | This is a single arm, open label study in which all patients will receive a single dose of the investigational product INCB007839 in combination with a standard regimen of trastuzumab and vinorelbine. Receives: Drug: INCB007839 300mg BID; Drug: Trastuzumab; Drug: Vinorelbine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of safety and tolerabilty as determined by monitoring the frequency and severity of adverse events (AEs) and performing clinical assessments and laboratory investigations.
Measured: Measured monthly starting at Baseline (estimated duration 6-9 months)
Secondary outcomes (1)
Overall objective response rate assessed by RECIST criteria
Measured: Measured at Baseline, Cycle 4 and approximately every 9 weeks after (estimated duration 6-9 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2010 (estimated)
- Study startOct 2010
- Primary completionSep 2011
- Study completionOct 2011
Why it stopped: Incyte has suspended development of the compound.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Incyte CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Denise A. Yardley, MD, Principal investigator, Sara Cannon Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01254136
- Sponsor's protocol ID
- INCB 7839-204
- Status last verified
- Jan 2012
- First submitted
- 1 Dec 2010
- Last updated
- 25 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Park EJ, Lee CW. Soluble receptors in cancer: mechanisms, clinical significance, and therapeutic strategies. Exp Mol Med. 2024 Feb;56(1):100-109. doi: 10.1038/s12276-023-01150-6. Epub 2024 Jan 5.
PubMed 38182653
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study to Assess the Safety and Therapeutic Effect of INCB007839 in Combination With Trastuzumab and Vinorelbine in Patients With Metastatic HER2+ Breast Cancer.
- ClinicalTrials.gov ID
- NCT01254136
- Acronym / sponsor ID
- INCB 7839-204
- Conditions
- Breast Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Incyte has suspended development of the compound.
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 6 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Phase I/II study is designed to assess the safety and therapeutic effect of INCB007839 in combination with trastuzumab and vinorelbine in patients with metastatic HER2+ breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment A - INCB007839 300mg BID | Experimental | Drug: INCB007839 300mg BID, Drug: Trastuzumab, Drug: VinorelbineThis is a single arm, open label study in which all patients will receive a single dose of the investigational product INCB007839 in combination with a standard regimen of trastuzumab and vinorelbine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject with diagnosis of metastatic (or locally recurrent-inoperable) breast cancer
- Subject with histological HER2+ status as determined by FISH with a gene amplification score of ≥ 2.2
- Subject with availability of archival biopsy tissue from primary tumor or metastatic lesions
- Subject with presence of measurable disease based on RECIST 1.1
- Subject who has received no more than three prior HER2-directed therapeutic regimens for advanced breast cancer
Key exclusion criteria (9 listed)
- Subject with Left ventricular ejection fraction (LVEF) below institutional normal range
- Subject with metastasis to the central nervous system UNLESS asymptomatic and clinically stable
- Subject with current active malignancy other than breast cancer
- Subject with prior history of other malignancy except for cancers from which the patient is currently disease free
- Subject with significant renal or hepatic dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INCB007839 300mg BIDINCB007839 tablets (300 mg BID) in combination with trastuzumab and vinorelbine will be administered in an initial Cycle of 28 days and followed by continuous 21-day cycles subsequently. Trastuzumab will be administered in continuous 21-day cycles beginning on Day 8 of Cycle 1. Vinorelbine will be administered on a weekly schedule for a minimum of the first four cycles beginning on Cycle 1 Day 8. All drugs will be administered continuously as tolerated or until a protocol-defined stopping criteria is met. | Drug | Treatment A - INCB007839 300mg BID |
| TrastuzumabINCB007839 tablets (300 mg BID) in combination with trastuzumab and vinorelbine will be administered in an initial Cycle of 28 days and followed by continuous 21-day cycles subsequently. Trastuzumab will be administered in continuous 21-day cycles beginning on Day 8 of Cycle 1. Vinorelbine will be administered on a weekly schedule for a minimum of the first four cycles beginning on Cycle 1 Day 8. All drugs will be administered continuously as tolerated or until a protocol-defined stopping criteria is met. | Drug | Treatment A - INCB007839 300mg BID |
| VinorelbineINCB007839 tablets (300 mg BID) in combination with trastuzumab and vinorelbine will be administered in an initial Cycle of 28 days and followed by continuous 21-day cycles subsequently. Trastuzumab will be administered in continuous 21-day cycles beginning on Day 8 of Cycle 1. Vinorelbine will be administered on a weekly schedule for a minimum of the first four cycles beginning on Cycle 1 Day 8. All drugs will be administered continuously as tolerated or until a protocol-defined stopping criteria is met. | Drug | Treatment A - INCB007839 300mg BID |
Primary outcome
Evaluation of safety and tolerabilty as determined by monitoring the frequency and severity of adverse events (AEs) and performing clinical assessments and laboratory investigations.
Time frame: Measured monthly starting at Baseline (estimated duration 6-9 months)
1 secondary outcome
Overall objective response rate assessed by RECIST criteria
Time frame: Measured at Baseline, Cycle 4 and approximately every 9 weeks after (estimated duration 6-9 months)
Results and safety
The study was stopped early (reason given: Incyte has suspended development of the compound.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2012.
- Derived from this study: PubMed 38182653Park EJ, Lee CW. Soluble receptors in cancer: mechanisms, clinical significance, and therapeutic strategies. Exp Mol Med. 2024 Feb;56(1):100-109. doi: 10.1038/s12276-023-01150-6. Epub 2024 Jan 5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Denise A. Yardley, MD principal investigator
Sara Cannon Research Institute
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing INCB007839 300mg BID, Trastuzumab and Vinorelbine in people with Breast Cancer, run by Incyte Corporation at 14 sites in United States.
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 5 inclusion and 9 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 25 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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: Incyte has suspended development of the compound.). 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?
Evaluation of safety and tolerabilty as determined by monitoring the frequency and severity of adverse events (AEs) and performing clinical assessments and laboratory investigations. (time frame: Measured monthly starting at Baseline (estimated duration 6-9 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 NCT01254136, 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 25 Jan 2012.