Solid Tumors and Hematologic MalignancyPhase 1NCT01195311
A Dose-escalation Study in Subjects With Advanced Malignancies
A Phase 1 study testing INCB024360 in people with Solid Tumors and Hematologic Malignancy, run by Incyte Corporation at 2 sites in United States.
Trial summary
This is an open label, dose escalation study using a 3 + 3 design to determine if INCB024360 (study drug) is safe, well-tolerated and effective in patients with advanced malignancies. 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?
- INCB024360
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2010to Jul 2013
- 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
- Subjects with neoplastic disease refractory to currently available therapies or for which no effective treatment is available
- Subjects with life expectancy of 12 weeks or longer.
- Subjects with Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
Who cannot join
- Subjects who received any anti-cancer medications in the 21 days prior to receiving their first dose of study medication or 6 weeks for mitomycin-C or nitrosoureas.
- Subjects with history of brain metastases or spinal cord compression.
- Subjects who have undergone a bone marrow or solid organ transplant.
- Subjects who have had major surgery within 4 weeks prior to study entry or had minor surgical procedure within 7 days prior to initiating treatment.
- Subjects with a history of any gastrointestinal condition
- Is receiving any compound that is known to be a potent inducer or inhibitor of CYP3A4
- Subjects with an active autoimmune process or is receiving therapy for an autoimmune disease
- Subjects treated with a serotonin reuptake inhibitor within 3 weeks prior to study entry
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Study site
Chicago, Illinois
Study site
Philadelphia, Pennsylvania
About this study
Official title: A Phase I, Open-Label, Dose-Escalation Study to Determine the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of INCB024360 in Patients With Advanced Malignancies
This is an open label, dose escalation study using a 3 + 3 design to determine if INCB024360 (study drug) is safe, well-tolerated and effective in patients with advanced malignancies. Patients will be enrolled and treated in cohorts of three and each observed a minimum of 28 days before the next group is enrolled and may begin to receive study drug. For subject safety, the first subject in each cohort will be administered drug for one week before the next two subjects in the cohort can begin drug administration. Doses will be escalated unless a dose-limiting toxicity (DLT) is observed in one of three subjects.
An expanded cohort of up to 15 patients may be recruited to further explore safety at the 'maximum tolerated dose' or at a lower, pharmacologically active, dose.
- Conditions
- Solid Tumors and Hematologic Malignancy
- Being tested
- INCB024360
- Keywords
- Refractory, Advanced malignancies
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INCB024360Drug
INCB024360: 25 mg and 100 mg tablets Doses will be escalated in accordance with the dosing schedule.
| Study group | Role | What they receive |
|---|---|---|
| INCB024360 | Experimental | Not described Receives: Drug: INCB024360 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability as measured by adverse events and dose limiting toxicities
Measured: Measured from baseline through follow-up period (measured during cycle 1 weekly and bi monthly thereafter)
Secondary outcomes (3)
Tumor assessment as measured by RECIST criteria
Measured: Measured from baseline through treatment cessation. (Measured every other cycle and end of study)
Measurement of IDO inhibition in whole blood measured through blood sampling.
Measured: Cycle 1, Day 1 and each 28 day subsequent cycle at Day 1
PK analysis
Measured: Full PK at Days 1, 8 (trough only), 15 at Cycle 1 and trough at each subsequent cycle at Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2010 (estimated)
- Study startJul 2010
- Primary completionMay 2013
- Study completionJul 2013
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lance Leopold, MD, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01195311
- Sponsor's protocol ID
- INCB 24360-101
- Status last verified
- Jan 2018
- First submitted
- 18 Aug 2010
- 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 Determine the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of INCB024360 in Patients With Advanced Malignancies
- ClinicalTrials.gov ID
- NCT01195311
- Acronym / sponsor ID
- INCB 24360-101
- Conditions
- Solid Tumors and Hematologic Malignancy
- Keywords
- Refractory, Advanced malignancies
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- May 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 6 Sep 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 is an open label, dose escalation study using a 3 + 3 design to determine if INCB024360 (study drug) is safe, well-tolerated and effective in patients with advanced malignancies. Patients will be enrolled and treated in cohorts of three and each observed a minimum of 28 days before the next group is enrolled and may begin to receive study drug. For subject safety, the first subject in each cohort will be administered drug for one week before the next two subjects in the cohort can begin drug administration. Doses will be escalated unless a dose-limiting toxicity (DLT) is observed in one of three subjects.
An expanded cohort of up to 15 patients may be recruited to further explore safety at the 'maximum tolerated dose' or at a lower, pharmacologically active, dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| INCB024360 | Experimental | Drug: INCB024360 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects with neoplastic disease refractory to currently available therapies or for which no effective treatment is available
- Subjects with life expectancy of 12 weeks or longer.
- Subjects with Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
Key exclusion criteria (8 listed)
- Subjects who received any anti-cancer medications in the 21 days prior to receiving their first dose of study medication or 6 weeks for mitomycin-C or nitrosoureas.
- Subjects with history of brain metastases or spinal cord compression.
- Subjects who have undergone a bone marrow or solid organ transplant.
- Subjects who have had major surgery within 4 weeks prior to study entry or had minor surgical procedure within 7 days prior to initiating treatment.
- Subjects with a history of any gastrointestinal condition
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 |
|---|---|---|
| INCB024360INCB024360: 25 mg and 100 mg tablets Doses will be escalated in accordance with the dosing schedule. | Drug | INCB024360 |
Primary outcome
Safety and tolerability as measured by adverse events and dose limiting toxicities
Time frame: Measured from baseline through follow-up period (measured during cycle 1 weekly and bi monthly thereafter)
3 secondary outcomes
Tumor assessment as measured by RECIST criteria
Time frame: Measured from baseline through treatment cessation. (Measured every other cycle and end of study)
Measurement of IDO inhibition in whole blood measured through blood sampling.
Time frame: Cycle 1, Day 1 and each 28 day subsequent cycle at Day 1
PK analysis
Time frame: Full PK at Days 1, 8 (trough only), 15 at Cycle 1 and trough at each subsequent cycle at Day 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.
Related trials for Solid Tumors and Hematologic Malignancy
RecruitingObservational study
Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
RecruitingPhase 3
Long-term Safety and Efficacy Extension Study for Participants With Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pembrolizumab (MK-3475) Study (MK-3475-587/KEYNOTE-587)
Solid Tumors, Hematologic Malignancies
RecruitingPhase 1
Alpha/Beta CD19+ Depleted Haploidentical Transplantation + Zometa for Pediatric Hematologic Malignancies and Solid Tumors
Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia
Not yet recruitingPhase 1/2
A Study of MDSY-1240, a STAT3 Degrader, for the Treatment of Hematologic Malignancies and Advanced Solid Tumors
Triple-Negative Breast Cancer (TNBC), Gastric Cancer (GC)
Active, not recruitingPhase 2
Testing AZD1775 as a Potential Targeted Treatment in Cancers With BRCA Genetic Changes (MATCH-Subprotocol Z1I)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
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.
Lance Leopold, MD study director
Incyte Corporation
2 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 INCB024360 in people with Solid Tumors and Hematologic Malignancy, run by Incyte Corporation at 2 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 3 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 2 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?
Safety and tolerability as measured by adverse events and dose limiting toxicities (time frame: Measured from baseline through follow-up period (measured during cycle 1 weekly and bi monthly thereafter)). 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.