Clinical trial · Interventional
Safety Study of Itacitinib (INCB039110) in Combination With Gemcitabine and Nab-Paclitaxel in Subjects With Advanced Solid Tumors
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
NCT01858883CI-TRIAL-00039551completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Test the hypothesis that itacitinib (INCB039110) can be administered safely in combination with gemcitabine and nab-paclitaxel in subjects with advanced or metastatic cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| filgrastim | Drug | Filgrastim | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| itacitinib | Drug | — | UNRESOLVED |
| nab-paclitaxel | Drug | Nab-paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- itacitinib, gemcitabine, nab-paclitaxel, filgrastim
- interventionNames
- Drug: itacitinib
- Drug: Gemcitabine
- Drug: nab-paclitaxel
- Drug: filgrastim
Primary outcomes (2)
- 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
- timeFrame
- 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).
- measure
- Identify the Maximum Tolerated Dose (MTD) or Pharmacologically Active Dose (PAD) within a defined dose range for itacitinib (INCB039110) in the treatment regimens administered
- timeFrame
- Each cohort will be observed for a minimum of 28 days.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (1)
- DERIVEDBeatty 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. PMID 30115734