Solid TumorsPhase 1/2NCT01858883
Safety Study of Itacitinib (INCB039110) in Combination With Gemcitabine and Nab-Paclitaxel in Subjects With Advanced Solid Tumors
A Phase 1/2 study testing itacitinib, Gemcitabine and nab-paclitaxel in people with Solid Tumors and Pancreatic Cancer, run by Incyte Corporation at 8 sites in United States.
Trial summary
Test the hypothesis that itacitinib (INCB039110) can be administered safely in combination with gemcitabine and nab-paclitaxel in subjects with advanced or metastatic cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors, Pancreatic Cancer
- What is being tested?
- itacitinib, Gemcitabine and nab-paclitaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 8 sitesUnited States
- Study dates
- Jun 2013to Mar 2016
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed solid tumor (Part 1) or pancreatic adenocarcinoma (Part 2)
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
- Received no more than 1 prior chemotherapy regimen for advanced or metastatic disease (not including neo-adjuvant and/or adjuvant therapy) (Part 1)
- Received no prior chemotherapy for advanced or metastatic disease (Part 2 and Part 2a)
- Adequate renal, hepatic, and bone marrow function without frequent blood product or hematopoietic growth factor support (eg use of erythropoietin or transfusions > 2 units packed red blood cells every 3 months)
- Ability to swallow and retain oral medication
Who cannot join
- Any known contraindications to the use of a required comedication (gemcitabine or nab-paclitaxel).
- Evidence of uncontrolled brain metastases or history of uncontrolled seizures.
- Ongoing radiation therapy and/or radiation therapy administered within 28 days of enrollment or ongoing radiotherapy-related toxicities.
- Presence of ≥ Grade 2 neuropathy.
- Inability to swallow food or any condition of the upper GI tract that precludes administration of oral medications.
- Recent (≤ 3 months) history of partial or complete bowel obstruction.
- Unwillingness to be transfused with blood components.
- Known history of Hepatitis B or C infection or HIV infection
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Study site
Baltimore, Maryland
Study site
Beverly Hills, California
Study site
Fayetteville, Arkansas
Study site
Indianapolis, Indiana
Study site
Lake Success, New York
Study site
Philadelphia, Pennsylvania
Study site
Scottsdale, Arizona
Study site
Southington, Connecticut
About this study
Official title: Official Title: A Phase 1B/2 Study of the Safety and Tolerability of Itacitinib (INCB039110) in Combination With Gemcitabine and Nab-Paclitaxel in Subjects With Advanced Solid Tumors
Test the hypothesis that itacitinib (INCB039110) can be administered safely in combination with gemcitabine and nab-paclitaxel in subjects with advanced or metastatic cancer.
Read the detailed description
Study Part 1: This is a dose optimization phase designed to find a tolerated regimen that includes identifying the MTD of itacitinib (INCB039110) (within a defined pharmacologic range) in combination with doses of gemcitabine and nab-paclitaxel that have established safety and tolerability in subjects with advanced or metastatic solid tumors.
Study Part 2 and Part 2A: This phase will explore the safety and tolerability of the MTD or PAD of itacitinib (INCB039110) when administered in combination with gemcitabine and nab-paclitaxel in subjects with untreated advanced or metastatic pancreatic cancer.
- Conditions
- Solid Tumors, Pancreatic Cancer
- Being tested
- itacitinib, Gemcitabine, nab-paclitaxel, filgrastim
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
itacitinibDrug
Also called INCB039110
GemcitabineDrug
Also called Gemzar®
nab-paclitaxelDrug
Also called Abraxane®
filgrastimDrug
Also called Neupogen®
| Study group | Role | What they receive |
|---|---|---|
| itacitinib, gemcitabine, nab-paclitaxel, filgrastim | Experimental | Not described Receives: Drug: itacitinib; Drug: Gemcitabine; Drug: nab-paclitaxel; Drug: filgrastim |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of combination therapy study treatment itacitinib (INCB039110) plus nab-paclitaxel and gemcitabine as measured by the number of participants with adverse events
Measured: Baseline and weekly for Cycle 1 and then Day 1, Week 8 and Week 15 for all subsequent cycles until the End of Treatment visit (approximately 6 months).
Identify the Maximum Tolerated Dose (MTD) or Pharmacologically Active Dose (PAD) within a defined dose range for itacitinib (INCB039110) in the treatment regimens administered
Measured: Each cohort will be observed for a minimum of 28 days.
Secondary outcomes (2)
Pharmacokinetics of gemcitabine and paclitaxel administered with or without concurrent itacitinib (INCB039110)
Measured: Baseline up to 6 months.
Clinical activity as measured by the greatest decrease in tumor burden compared to baseline.
Measured: Baseline and approximately every two cycles throughout the study until study completion or early termination (approximately 6 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2013 (estimated)
- Study startJun 2013
- Primary completionFeb 2016
- Study completionMar 2016
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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Albert Assad, M.D., Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01858883
- Sponsor's protocol ID
- INCB 39110-116
- Status last verified
- Jul 2019
- First submitted
- 14 May 2013
- Last updated
- 18 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Beatty GL, Shahda S, Beck T, Uppal N, Cohen SJ, Donehower R, Gabayan AE, Assad A, Switzky J, Zhen H, Von Hoff DD. A Phase Ib/II Study of the JAK1 Inhibitor, Itacitinib, plus nab-Paclitaxel and Gemcitabine in Advanced Solid Tumors. Oncologist. 2019 Jan;24(1):14-e10. doi: 10.1634/theoncologist.2017-0665. Epub 2018 Aug 16.
PubMed 30115734
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Official Title: A Phase 1B/2 Study of the Safety and Tolerability of Itacitinib (INCB039110) in Combination With Gemcitabine and Nab-Paclitaxel in Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT01858883
- Acronym / sponsor ID
- INCB 39110-116
- Conditions
- Solid Tumors, Pancreatic Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Feb 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 21 May 2013 (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.
Test the hypothesis that itacitinib (INCB039110) can be administered safely in combination with gemcitabine and nab-paclitaxel in subjects with advanced or metastatic cancer.
Detailed description
Study Part 1: This is a dose optimization phase designed to find a tolerated regimen that includes identifying the MTD of itacitinib (INCB039110) (within a defined pharmacologic range) in combination with doses of gemcitabine and nab-paclitaxel that have established safety and tolerability in subjects with advanced or metastatic solid tumors.
Study Part 2 and Part 2A: This phase will explore the safety and tolerability of the MTD or PAD of itacitinib (INCB039110) when administered in combination with gemcitabine and nab-paclitaxel in subjects with untreated advanced or metastatic pancreatic cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| itacitinib, gemcitabine, nab-paclitaxel, filgrastim | Experimental | Drug: itacitinib, Drug: Gemcitabine, Drug: nab-paclitaxel, Drug: filgrastim |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically or cytologically confirmed solid tumor (Part 1) or pancreatic adenocarcinoma (Part 2)
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
- Received no more than 1 prior chemotherapy regimen for advanced or metastatic disease (not including neo-adjuvant and/or adjuvant therapy) (Part 1)
- Received no prior chemotherapy for advanced or metastatic disease (Part 2 and Part 2a)
- Adequate renal, hepatic, and bone marrow function without frequent blood product or hematopoietic growth factor support (eg use of erythropoietin or transfusions > 2 units packed red blood cells every 3 months)
Key exclusion criteria (8 listed)
- Any known contraindications to the use of a required comedication (gemcitabine or nab-paclitaxel).
- Evidence of uncontrolled brain metastases or history of uncontrolled seizures.
- Ongoing radiation therapy and/or radiation therapy administered within 28 days of enrollment or ongoing radiotherapy-related toxicities.
- Presence of ≥ Grade 2 neuropathy.
- Inability to swallow food or any condition of the upper GI tract that precludes administration of oral medications.
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: INCB039110 | Drug | itacitinib, gemcitabine, nab-paclitaxel, filgrastim |
| GemcitabineAlso: Gemzar® | Drug | itacitinib, gemcitabine, nab-paclitaxel, filgrastim |
| nab-paclitaxelAlso: Abraxane® | Drug | itacitinib, gemcitabine, nab-paclitaxel, filgrastim |
| filgrastimAlso: Neupogen® | Drug | itacitinib, gemcitabine, nab-paclitaxel, filgrastim |
Primary outcome
Safety and tolerability of combination therapy study treatment itacitinib (INCB039110) plus nab-paclitaxel and gemcitabine as measured by the number of participants with adverse events
Time frame: Baseline and weekly for Cycle 1 and then Day 1, Week 8 and Week 15 for all subsequent cycles until the End of Treatment visit (approximately 6 months).
Identify the Maximum Tolerated Dose (MTD) or Pharmacologically Active Dose (PAD) within a defined dose range for itacitinib (INCB039110) in the treatment regimens administered
Time frame: Each cohort will be observed for a minimum of 28 days.
2 secondary outcomes
Pharmacokinetics of gemcitabine and paclitaxel administered with or without concurrent itacitinib (INCB039110)
Time frame: Baseline up to 6 months.
Clinical activity as measured by the greatest decrease in tumor burden compared to baseline.
Time frame: Baseline and approximately every two cycles throughout the study until study completion or early termination (approximately 6 months).
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 18 Jul 2019.
- Derived from this study: PubMed 30115734Beatty GL, Shahda S, Beck T, Uppal N, Cohen SJ, Donehower R, Gabayan AE, Assad A, Switzky J, Zhen H, Von Hoff DD. A Phase Ib/II Study of the JAK1 Inhibitor, Itacitinib, plus nab-Paclitaxel and Gemcitabine in Advanced Solid Tumors. Oncologist. 2019 Jan;24(1):14-e10. doi: 10.1634/theoncologist.2017-0665. Epub 2018 Aug 16.
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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.
Albert Assad, M.D. study director
Incyte Corporation
8 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 itacitinib, Gemcitabine and nab-paclitaxel in people with Solid Tumors and Pancreatic Cancer, run by Incyte Corporation at 8 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 6 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 18 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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 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 of combination therapy study treatment itacitinib (INCB039110) plus nab-paclitaxel and gemcitabine as measured by the number of participants with adverse events (time frame: Baseline and weekly for Cycle 1 and then Day 1, Week 8 and Week 15 for all subsequent cycles until the End of Treatment visit (approximately 6 months).). The study lists 2 primary outcomes in all. 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 NCT01858883, 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 18 Jul 2019.