Solid TumorsPhase 1NCT02559492
Itacitinib Combined With INCB024360 and/or Itacitinib Combined With INCB050465 in Advanced Solid Tumors
A Phase 1 study testing Itacitinib, Epacadostat and INCB050465 in people with Solid Tumors, run by Incyte Corporation at 11 sites in United States.
Trial summary
This is an open-label, Phase 1b, platform study in subjects with advanced or metastatic solid tumors. The study will be divided into 3 parts (Part 1a, Part 1b, and Part 2). Part 1a will evaluate a JAK inhibitor with JAK1 selectivity (Itacitinib) in combination with an IDO1 inhibitor (epacadostat; INCB024360; Group A)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- Itacitinib, Epacadostat and INCB050465
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 11 sitesUnited States
- Study dates
- Nov 2015to 18 Aug 2019
- 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
- Male or female, age 18 years or older.
- Willingness to provide written informed consent for the study.
- Part 1a: Subjects with histologically or cytologically confirmed advanced or metastatic solid tumors that have failed prior standard therapy (including subject refusal or intolerance).
- Part 1b: Subjects with endometrial cancer, gastric cancer, head and neck squamous cell carcinoma, melanoma, microsatellite unstable colorectal cancer, non-small cell lung cancer, pancreatic ductal adenocarcinoma, renal cell carcinoma, triple negative breast cancer, or transitional cell carcinoma of the genitourinary tract that have had disease progression after available therapies for metastatic disease that are known to confer clinical benefit, been intolerant to treatment, or refused standard treatment.
- Part 1b: Must have documented confirmed disease progression on a prior programmed cell death-1 (PD-1) pathway targeted agent or must be PD-1 pathway-targeted treatment naïve.
- Part 2: Subjects with HNSCC, NSCLC, pancreatic ductal adenocarcinoma, salivary gland cancer, and transitional cell carcinoma of the genitourinary tract that have had disease progression after available therapies for advanced or metastatic disease that are known to confer clinical benefit, have been intolerant to treatment, or have refused standard treatment.
- Willingness to undergo a pre-treatment and on-treatment tumor biopsy to obtain the specimen.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Who cannot join
- Laboratory parameters not within the protocol-defined range.
- Receipt of anticancer medications or investigational drugs within a defined interval before the first administration of study drug.
- Received an immune-suppressive based treatment for any reason within 14 days prior to the first dose of study treatment.
- Has not recovered from toxic effect of prior therapy to < Grade 1.
- Active or inactive autoimmune process.
- Has received a live vaccine within 30 days of planned start of study therapy.
- Active infection requiring systemic therapy.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Study site
Chicago, Illinois
Study site
Dallas, Texas
Study site
Denver, Colorado
Study site
Duarte, California
Study site
Houston, Texas
Study site
Huntersville, North Carolina
Study site
Nashville, Tennessee
Study site
New Haven, Connecticut
Study site
Rochester, Minnesota
Study site
Salt Lake City, Utah
Study site
Tampa, Florida
About this study
Official title: A Platform Study Exploring the Safety, Tolerability, Effect on the Tumor Microenvironment, and Efficacy of INCB Combinations in Advanced Solid Tumors
This is an open-label, Phase 1b, platform study in subjects with advanced or metastatic solid tumors. The study will be divided into 3 parts (Part 1a, Part 1b, and Part 2). Part 1a will evaluate a JAK inhibitor with JAK1 selectivity (Itacitinib) in combination with an IDO1 inhibitor (epacadostat; INCB024360; Group A) and Itacitinib in combination with a PI3K-delta inhibitor (INCB050465; Group B) to determine the MTD or PAD and the recommended Part 1b doses for each combination. Once the recommended dose has been identified for each treatment group in Part 1a, subjects with advanced solid tumors will be enrolled into expansion cohorts based upon prior treatment history with a PD-1 pathway-targeted agent (Part 1b). In Part 2, additional expansion cohorts will be enrolled to further evaluate lower doses of itacitinib and INCB050465 in subjects with select tumor types.
- Conditions
- Solid Tumors
- Being tested
- Itacitinib, Epacadostat, INCB050465
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ItacitinibDrug
Also called INCB039110
Itacitinib (INCB039110) tablets will be administered orally once daily in the morning.
EpacadostatDrug
Epacadostat tablets will be administered orally, twice daily.
ItacitinibDrug
Also called INCB039110
Itacitinib (INCB039110) tablets will be administered orally once daily in the morning.
INCB050465Drug
INCB050465 tablets will be administered orally once daily.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Itacitinib + epacadostat | Experimental | Group A will utilize an open-label 3+3 dose-escalation design based on observing each dose level for a period of 21 days. Receives: Drug: Itacitinib; Drug: Epacadostat |
| Group B: Itacitinib + INCB050465 | Experimental | Group B will utilize an open-label 3+3 dose-escalation design based on observing each dose level for a period of 21 days. Receives: Drug: Itacitinib; Drug: INCB050465 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Dose Limiting Toxicities (DLTs)
Safety and tolerability of the treatment groups.
Measured: Baseline through 21 days
Secondary outcomes (3)
Objective response rate (ORR)
Tumor response rates in those subjects with measurable disease.
Measured: Every 9 weeks for duration of study participation which is estimated to be 18 months
Progression Free Survival (PFS)
Progression-free survival, defined as the time from enrollment until the earliest date of disease progression.
Measured: Every 9 weeks for duration of study participation which is estimated to be 18 months
Duration of response (DOR)
Duration of response determined by radiographic disease assessment.
Measured: Every 9 weeks for duration of study participation which is estimated to be 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2015 (estimated)
- Study startNov 2015
- Primary completion10 Sep 2018
- Study completion18 Aug 2019
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 Solid TumorsStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 142 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
- NCT02559492
- Sponsor's protocol ID
- 39110-106
- Status last verified
- Sep 2019
- First submitted
- 23 Sep 2015
- Last updated
- 25 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Naing A, Powderly JD, Nemunaitis JJ, Luke JJ, Mansfield AS, Messersmith WA, Sahebjam S, LoRusso PM, Garrido-Laguna I, Leopold L, Geschwindt R, Ding K, Smith M, Berlin JD. Exploring the safety, effect on the tumor microenvironment, and efficacy of itacitinib in combination with epacadostat or parsaclisib in advanced solid tumors: a phase I study. J Immunother Cancer. 2022 Mar;10(3):e004223. doi: 10.1136/jitc-2021-004223.
PubMed 35288468
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Platform Study Exploring the Safety, Tolerability, Effect on the Tumor Microenvironment, and Efficacy of INCB Combinations in Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT02559492
- Acronym / sponsor ID
- 39110-106
- Conditions
- Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- Nov 2015
- Primary completion
- 10 Sep 2018 (actual)
- Study completion
- 18 Aug 2019 (actual)
- First posted
- 24 Sep 2015 (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, Phase 1b, platform study in subjects with advanced or metastatic solid tumors. The study will be divided into 3 parts (Part 1a, Part 1b, and Part 2). Part 1a will evaluate a JAK inhibitor with JAK1 selectivity (Itacitinib) in combination with an IDO1 inhibitor (epacadostat; INCB024360; Group A) and Itacitinib in combination with a PI3K-delta inhibitor (INCB050465; Group B) to determine the MTD or PAD and the recommended Part 1b doses for each combination. Once the recommended dose has been identified for each treatment group in Part 1a, subjects with advanced solid tumors will be enrolled into expansion cohorts based upon prior treatment history with a PD-1 pathway-targeted agent (Part 1b). In Part 2, additional expansion cohorts will be enrolled to further evaluate lower doses of itacitinib and INCB050465 in subjects with select tumor types.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Itacitinib + epacadostat | Experimental | Drug: Itacitinib, Drug: EpacadostatGroup A will utilize an open-label 3+3 dose-escalation design based on observing each dose level for a period of 21 days. |
| Group B: Itacitinib + INCB050465 | Experimental | Drug: Itacitinib, Drug: INCB050465Group B will utilize an open-label 3+3 dose-escalation design based on observing each dose level for a period of 21 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female, age 18 years or older.
- Willingness to provide written informed consent for the study.
- Part 1a: Subjects with histologically or cytologically confirmed advanced or metastatic solid tumors that have failed prior standard therapy (including subject refusal or intolerance).
- Part 1b: Subjects with endometrial cancer, gastric cancer, head and neck squamous cell carcinoma, melanoma, microsatellite unstable colorectal cancer, non-small cell lung cancer, pancreatic ductal adenocarcinoma, renal cell carcinoma, triple negative breast cancer, or transitional cell carcinoma of the genitourinary tract that have had disease progression after available therapies for metastatic disease that are known to confer clinical benefit, been intolerant to treatment, or refused standard treatment.
- Part 1b: Must have documented confirmed disease progression on a prior programmed cell death-1 (PD-1) pathway targeted agent or must be PD-1 pathway-targeted treatment naïve.
Key exclusion criteria (7 listed)
- Laboratory parameters not within the protocol-defined range.
- Receipt of anticancer medications or investigational drugs within a defined interval before the first administration of study drug.
- Received an immune-suppressive based treatment for any reason within 14 days prior to the first dose of study treatment.
- Has not recovered from toxic effect of prior therapy to < Grade 1.
- Active or inactive autoimmune process.
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 |
|---|---|---|
| ItacitinibAlso: INCB039110Itacitinib (INCB039110) tablets will be administered orally once daily in the morning. | Drug | Group A: Itacitinib + epacadostat |
| EpacadostatEpacadostat tablets will be administered orally, twice daily. | Drug | Group A: Itacitinib + epacadostat |
| ItacitinibAlso: INCB039110Itacitinib (INCB039110) tablets will be administered orally once daily in the morning. | Drug | Group B: Itacitinib + INCB050465 |
| INCB050465INCB050465 tablets will be administered orally once daily. | Drug | Group B: Itacitinib + INCB050465 |
Primary outcome
Number of Participants With Dose Limiting Toxicities (DLTs)
Time frame: Baseline through 21 days
Safety and tolerability of the treatment groups.
3 secondary outcomes
Objective response rate (ORR)
Time frame: Every 9 weeks for duration of study participation which is estimated to be 18 months
Progression Free Survival (PFS)
Time frame: Every 9 weeks for duration of study participation which is estimated to be 18 months
Duration of response (DOR)
Time frame: Every 9 weeks for duration of study participation which is estimated to be 18 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
- Derived from this study: PubMed 35288468Naing A, Powderly JD, Nemunaitis JJ, Luke JJ, Mansfield AS, Messersmith WA, Sahebjam S, LoRusso PM, Garrido-Laguna I, Leopold L, Geschwindt R, Ding K, Smith M, Berlin JD. Exploring the safety, effect on the tumor microenvironment, and efficacy of itacitinib in combination with epacadostat or parsaclisib in advanced solid tumors: a phase I study. J Immunother Cancer. 2022 Mar;10(3):e004223. doi: 10.1136/jitc-2021-004223.
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A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
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IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
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Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
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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.
Lance Leopold, MD study director
Incyte Corporation
11 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 Itacitinib, Epacadostat and INCB050465 in people with Solid Tumors, run by Incyte Corporation at 11 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 8 inclusion and 7 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 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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 was stopped early. 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?
Number of Participants With Dose Limiting Toxicities (DLTs) (time frame: Baseline through 21 days). 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 NCT02559492, 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 Sep 2019.