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A Phase 1B Study of the Safety and Tolerability of INCB039110 in Combination With Gemcitabine and Nab-Paclitaxel in Subjects With Advanced Solid Tumors

Phase 1
18 Years
Open (Enrolling)
Metastatic Cancer, Metastatic Pancreatic Cancer

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Trial Information

A Phase 1B Study of the Safety and Tolerability of INCB039110 in Combination With Gemcitabine and Nab-Paclitaxel in Subjects With Advanced Solid Tumors

Study Part 1: This is a dose optimization phase designed to find a tolerated regimen that
includes the maximum tolerated dose of 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: This phase will explore the safety and clinical activity of the regimen
identified in Part 1, in subjects with advanced or metastatic pancreatic cancer.

Inclusion Criteria:

- Histologically or cytologically confirmed solid tumor (Part 1) or pancreatic
adenocarcinoma (Part 2)

- 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)

- There is no restriction on the number of prior non-myelosuppressive targeted
therapies or hormonal agents (eg, EGFR targeted therapy for lung cancer and hormonal
therapy for breast cancer or ovarian cancer); targeted and/or hormonal therapy alone
will not be considered chemotherapy for the purposes of this study.

- Adequate renal, hepatic, and bone marrow function without blood product or
hematopoietic growth factor support:

- Ability to swallow and retain oral medication

Exclusion Criteria:

- Any known contraindications to the use of 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

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety and tolerability of the treatment regimen as measured by the number of participants with adverse events.

Outcome 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).

Safety Issue:


Principal Investigator

William V. Williams, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Incyte Corporation


United States: Food and Drug Administration

Study ID:

INCB 39110-116



Start Date:

June 2013

Completion Date:

October 2014

Related Keywords:

  • Metastatic Cancer
  • Metastatic Pancreatic Cancer
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary
  • Pancreatic Neoplasms



Phoenix, Arizona  85012