Breast CancerPhase 1/2NCT00864175
Open Label Trial of INCB07839 to Determine Effect and Safety of INCB007839 Plus Trastuzumab in HER2 Positive Metastatic Breast Cancer
A Phase 1/2 study testing INCB007839, trastuzumab and Docetaxel in people with Breast Cancer, run by Incyte Corporation at 12 sites in India.
Trial summary
This is a single arm, modified dose escalation, open label trial with the objectives of: (1) Determining a safe optimal dose of INCB007839 in combination with trastuzumab and docetaxel (2) Determining clinical efficacy and safety of INCB007839 in combination with trastuzumab and docetaxel. 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, trastuzumab and Docetaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 12 sitesIndia
- Study dates
- Jul 2007to 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
- Histologically or cytologically confirmed metastatic breast carcinoma that is HER2 positive
- Measurable disease as defined by the RECIST criteria
- Life expectancy greater than or equal to 6 months
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Who cannot join
- Received any anticancer medications in the 28 days prior to enrollment into this study
- Received any anticancer medications for cancers other than breast cancer within 6 months prior to enrollment in this study.
- History of deep venous thrombosis within the last year
- Contraindication to low dose warfarin therapy
- Clinically significant cardiomyopathy
- Prior treatment with INCB007839 or trastuzumab or lapatinib
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
India12 sites
Study site
Bangalore, Karnataka
Study site
Bangalore, Ram Nagar
Study site
Bhopal
Study site
Delhi, Rohini
Study site
Delhi, Vasundhara Enclave
Study site
Hyderabaad, Punjagutta
Study site
Kolkata
Study site
Mangalore, Attavar
Study site
Nashik
Study site
New Delhi, Ansari Nagar
Study site
Pune
Study site
Visakhapatnam, Andhra Pradesh
About this study
Official title: A Phase 1/2, Modified Dose Escalation, Open Label Trial to Determine the Therapeutic Effect and Safety of INCB007839 Combined With Trastuzumab in Patients With Previously Untreated HER2 Positive Metastatic Breast Cancer
This is a single arm, modified dose escalation, open label trial with the objectives of: (1) Determining a safe optimal dose of INCB007839 in combination with trastuzumab and docetaxel (2) Determining clinical efficacy and safety of INCB007839 in combination with trastuzumab and docetaxel.
- Conditions
- Breast Cancer
- Being tested
- INCB007839, trastuzumab, Docetaxel
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INCB007839Drug
100 mg BID
INCB007839Drug
200 mg BID
INCB007839Drug
300 mg BID
INCB007839Drug
300 mg BID
trastuzumabDrug
trastuzumab will be administered at a loading dose of 8 mg/kg as a 90 minute intravenous infusion on Day 8. In all subsequent 21-day cycles, trastuzumab will be administered at 6 mg/kg as a 90 minute intravenous infusion on Day 1.
DocetaxelDrug
| Study group | Role | What they receive |
|---|---|---|
| Treatment A - INCB007839 and Trastuzumab | Experimental | INCB007839 100 mg BID and trastuzumab
In Cycle 1, trastuzumab will be administered at a loading dose of 8 mg/kg as a 90 minute intravenous infusion on Day 8. In all subsequent 21-day cycles, trastuzumab will be administered at 6 mg/kg as a 90 minute intravenous infusion on Day 1. Receives: Drug: INCB007839; Drug: trastuzumab |
| Treatment B - INCB007839 and Trastuzumab | Experimental | INCB007839 200 mg BID and trastuzumab
In Cycle 1, trastuzumab will be administered at a loading dose of 8 mg/kg as a 90 minute intravenous infusion on Day 8. In all subsequent 21-day cycles, trastuzumab will be administered at 6 mg/kg as a 90 minute intravenous infusion on Day 1. Receives: Drug: INCB007839; Drug: trastuzumab |
| Treatment C - INCB007839 and Trastuzumab | Experimental | INCB007839 300 mg BID and trastuzumab
In Cycle 1, trastuzumab will be administered at a loading dose of 8 mg/kg as a 90 minute intravenous infusion on Day 8. In all subsequent 21-day cycles, trastuzumab will be administered at 6 mg/kg as a 90 minute intravenous infusion on Day 1. Receives: Drug: INCB007839; Drug: trastuzumab |
| Treatment D - INCB007839 and Docetaxel | Experimental | INCB007839 300mg BID with docetaxel Receives: Drug: INCB007839; Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate (complete + partial response) using RECIST (Response Evaluation Criteria in Solid Tumor) criteria
Measured: Day 1 of each completed subsequent 21-day treatment cycle and the End of Study Visit.
Secondary outcomes (1)
To determine the plasma pharmacokinetic (PK) profile of INCB007839 and trastuzumab when given in combination
For Cycle 1, PK samples to be collected on Day 8 and Day 15 at pre-dose the morning dose of INCB007839. For Cycles 2, 3 and 4, PK will be collected as a single sample, obtained at pre-dose, on Day 1. PK samples will not be collected at Cycle 5 or later.
- For Cycle 1, PD samples to be collected at time of screening and at pre-dose on Day 1, Day
Measured: Monthly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2009 (estimated)
- Study startJul 2007
- Primary completionJun 2011
- Study completionOct 2011
Why it stopped: Incyte suspended development of the compound.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bijyoyesh Mookerjee, MD, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00864175
- Sponsor's protocol ID
- INCB 7839-202
- Status last verified
- Jan 2018
- First submitted
- 26 Jan 2009
- Last updated
- 18 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2, Modified Dose Escalation, Open Label Trial to Determine the Therapeutic Effect and Safety of INCB007839 Combined With Trastuzumab in Patients With Previously Untreated HER2 Positive Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00864175
- Acronym / sponsor ID
- INCB 7839-202
- Conditions
- Breast Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Incyte suspended development of the compound.
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Jun 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 18 Mar 2009 (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 is a single arm, modified dose escalation, open label trial with the objectives of: (1) Determining a safe optimal dose of INCB007839 in combination with trastuzumab and docetaxel (2) Determining clinical efficacy and safety of INCB007839 in combination with trastuzumab and docetaxel.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment A - INCB007839 and Trastuzumab | Experimental | Drug: INCB007839, Drug: trastuzumabINCB007839 100 mg BID and trastuzumab In Cycle 1, trastuzumab will be administered at a loading dose of 8 mg/kg as a 90 minute intravenous infusion on Day 8. In all subsequent 21-day cycles, trastuzumab will be administered at 6 mg/kg as a 90 minute intravenous infusion on Day 1. |
| Treatment B - INCB007839 and Trastuzumab | Experimental | Drug: INCB007839, Drug: trastuzumabINCB007839 200 mg BID and trastuzumab In Cycle 1, trastuzumab will be administered at a loading dose of 8 mg/kg as a 90 minute intravenous infusion on Day 8. In all subsequent 21-day cycles, trastuzumab will be administered at 6 mg/kg as a 90 minute intravenous infusion on Day 1. |
| Treatment C - INCB007839 and Trastuzumab | Experimental | Drug: INCB007839, Drug: trastuzumabINCB007839 300 mg BID and trastuzumab In Cycle 1, trastuzumab will be administered at a loading dose of 8 mg/kg as a 90 minute intravenous infusion on Day 8. In all subsequent 21-day cycles, trastuzumab will be administered at 6 mg/kg as a 90 minute intravenous infusion on Day 1. |
| Treatment D - INCB007839 and Docetaxel | Experimental | Drug: INCB007839, Drug: DocetaxelINCB007839 300mg BID with docetaxel |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically or cytologically confirmed metastatic breast carcinoma that is HER2 positive
- Measurable disease as defined by the RECIST criteria
- Life expectancy greater than or equal to 6 months
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Key exclusion criteria (6 listed)
- Received any anticancer medications in the 28 days prior to enrollment into this study
- Received any anticancer medications for cancers other than breast cancer within 6 months prior to enrollment in this study.
- History of deep venous thrombosis within the last year
- Contraindication to low dose warfarin therapy
- Clinically significant cardiomyopathy
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 |
|---|---|---|
| INCB007839100 mg BID | Drug | Treatment A - INCB007839 and Trastuzumab |
| INCB007839200 mg BID | Drug | Treatment B - INCB007839 and Trastuzumab |
| INCB007839300 mg BID | Drug | Treatment C - INCB007839 and Trastuzumab |
| INCB007839300 mg BID | Drug | Treatment D - INCB007839 and Docetaxel |
| trastuzumabtrastuzumab will be administered at a loading dose of 8 mg/kg as a 90 minute intravenous infusion on Day 8. In all subsequent 21-day cycles, trastuzumab will be administered at 6 mg/kg as a 90 minute intravenous infusion on Day 1. | Drug | Treatment A - INCB007839 and Trastuzumab, Treatment B - INCB007839 and Trastuzumab, Treatment C - INCB007839 and Trastuzumab |
| Docetaxel | Drug | Treatment D - INCB007839 and Docetaxel |
Primary outcome
Overall response rate (complete + partial response) using RECIST (Response Evaluation Criteria in Solid Tumor) criteria
Time frame: Day 1 of each completed subsequent 21-day treatment cycle and the End of Study Visit.
1 secondary outcome
To determine the plasma pharmacokinetic (PK) profile of INCB007839 and trastuzumab when given in combination
Time frame: Monthly
Results and safety
The study was stopped early (reason given: Incyte suspended development of the compound.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2018.
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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.
Bijyoyesh Mookerjee, MD study director
Incyte Corporation
12 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, trastuzumab and Docetaxel in people with Breast Cancer, run by Incyte Corporation at 12 sites in India.
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 4 inclusion and 6 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 18 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in India. 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 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?
Overall response rate (complete + partial response) using RECIST (Response Evaluation Criteria in Solid Tumor) criteria (time frame: Day 1 of each completed subsequent 21-day treatment cycle and the End of Study Visit.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jan 2018.