Solid Tumors and Hematologic MalignancyPhase 1NCT00820560
Open-Label Study to Assess the Safety/Tolerability in Patients With Solid Tumors
A Phase 1 study testing INCB007839 in people with Solid Tumors and Hematologic Malignancy, run by Incyte Corporation at 4 sites in United States.
Trial summary
To establish the maximum tolerated dose (MTD) of INCB007839 given as multiple doses for 28 days and to determine if a higher MTD can be established when INCB007839 is administered in combination with prophylactic anticoagulation and with a 2 and a half day (5 doses) treatment interruption every two weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors and Hematologic Malignancy
- What is being tested?
- INCB007839
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 4 sitesUnited States
- Study dates
- Jan 2005to Jan 2009
- Phase
- Phase 1
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Either non-small cell lung cancer, hormone-refractory prostate cancer, colorectal cancer, breast cancer, or squamous cell cancer of the head and neck that is refractory to standard treatment or for which no effective treatment exists. The patient must have a life expectancy of 12 weeks or longer.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Who cannot join
- Received any anticancer medications in the 28 days prior to receiving their first dose of study medication
- Evidence of venous thrombosis by flow Doppler examination at Screening
- A history of thrombosis or a coagulation disorder
- Patients with a contraindication to use of low dose warfarin and/or aspirin.
- Any unresolved toxicity greater than grade 2 from previous anticancer therapy, except for stable chronic toxicities not expected to resolve
- Brain metastases or spinal cord compression
- Impaired renal function
- Inadequate bone marrow reserve
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Study site
Aurora, Colorado
Study site
Baltimore, Maryland
Study site
Nashville, Tennessee
Study site
Philadelphia, Pennsylvania
About this study
Official title: A Phase I, Open-Label, Dose-Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of INCB007839 Following Multiple Oral Doses in Patients With Solid Tumors
To establish the maximum tolerated dose (MTD) of INCB007839 given as multiple doses for 28 days and to determine if a higher MTD can be established when INCB007839 is administered in combination with prophylactic anticoagulation and with a 2 and a half day (5 doses) treatment interruption every two weeks.
- Conditions
- Solid Tumors and Hematologic Malignancy
- Being tested
- INCB007839
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INCB007839Drug
INCB007839 100 or 200 mg/dose as IR capsules
| Study group | Role | What they receive |
|---|---|---|
| INCB07839 100mg, immediate release (IR) capsules | Experimental | Not described Receives: Drug: INCB007839 |
| INCB07839 200 mg IR capsules | Experimental | Not described Receives: Drug: INCB007839 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify a maximum tolerable dose as measured through adverse event reporting, ECGs and laboratory assessments
Measured: Baseline through study completion
Secondary outcomes (3)
Evaluation of response rates as measured by RECIST criteria
Measured: At Screening, Day 1 of all 28 day cycles beginning of each subsequent odd numbered cycle.
Evaluation of PSA laboratory values for response
Measured: Baseline and every visit through study termination
Evaluation of PD markers for HER2 and ErbB ligand levels
Measured: Measured at screening and Day 1 of all subsequent 28 days cycles and Day 15 of Cycle 1.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2009 (estimated)
- Study startJan 2005
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumors and Hematologic MalignancyStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William V Williams, MD, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00820560
- Sponsor's protocol ID
- INCB 7839-201
- Status last verified
- Jan 2018
- First submitted
- 8 Jan 2009
- Last updated
- 17 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-Label, Dose-Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of INCB007839 Following Multiple Oral Doses in Patients With Solid Tumors
- ClinicalTrials.gov ID
- NCT00820560
- Acronym / sponsor ID
- INCB 7839-201
- Conditions
- Solid Tumors and Hematologic Malignancy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- Jan 2005
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 12 Jan 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.
To establish the maximum tolerated dose (MTD) of INCB007839 given as multiple doses for 28 days and to determine if a higher MTD can be established when INCB007839 is administered in combination with prophylactic anticoagulation and with a 2 and a half day (5 doses) treatment interruption every two weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| INCB07839 100mg, immediate release (IR) capsules | Experimental | Drug: INCB007839 |
| INCB07839 200 mg IR capsules | Experimental | Drug: INCB007839 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Either non-small cell lung cancer, hormone-refractory prostate cancer, colorectal cancer, breast cancer, or squamous cell cancer of the head and neck that is refractory to standard treatment or for which no effective treatment exists. The patient must have a life expectancy of 12 weeks or longer.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Key exclusion criteria (8 listed)
- Received any anticancer medications in the 28 days prior to receiving their first dose of study medication
- Evidence of venous thrombosis by flow Doppler examination at Screening
- A history of thrombosis or a coagulation disorder
- Patients with a contraindication to use of low dose warfarin and/or aspirin.
- Any unresolved toxicity greater than grade 2 from previous anticancer therapy, except for stable chronic toxicities not expected to resolve
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 |
|---|---|---|
| INCB007839INCB007839 100 or 200 mg/dose as IR capsules | Drug | INCB07839 100mg, immediate release (IR) capsules, INCB07839 200 mg IR capsules |
Primary outcome
Identify a maximum tolerable dose as measured through adverse event reporting, ECGs and laboratory assessments
Time frame: Baseline through study completion
3 secondary outcomes
Evaluation of response rates as measured by RECIST criteria
Time frame: At Screening, Day 1 of all 28 day cycles beginning of each subsequent odd numbered cycle.
Evaluation of PSA laboratory values for response
Time frame: Baseline and every visit through study termination
Evaluation of PD markers for HER2 and ErbB ligand levels
Time frame: Measured at screening and Day 1 of all subsequent 28 days cycles and Day 15 of Cycle 1.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 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.
William V Williams, MD study director
Incyte Corporation
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing INCB007839 in people with Solid Tumors and Hematologic Malignancy, run by Incyte Corporation at 4 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 2 inclusion and 8 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: finished, as of the sponsor's last update on 17 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 4 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 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.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Identify a maximum tolerable dose as measured through adverse event reporting, ECGs and laboratory assessments (time frame: Baseline through study completion). 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 17 Jan 2018.