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A Phase 1b Study of the Safety and Tolerability of Ruxolitinib in Combination With Gemcitabine With or Without 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 Ruxolitinib in Combination With Gemcitabine With or Without Nab-Paclitaxel in Subjects With Advanced Solid Tumors

Inclusion Criteria:

- Male or female, 18 years or older

- Histologically or cytologically confirmed solid tumor (Part 1) or pancreatic cancer
(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:

- Able to swallow and retain oral medication

Exclusion Criteria:

- Any known contraindications to the use of gemcitabine (for enrollment in Regimen A or
B) or nab-paclitaxel (for enrollment into Regimen B).

- Evidence of CNS metastases (unless stable for > 3 months) or history of uncontrolled

- Ongoing radiation therapy and/or radiation therapy administered within 28 days of
enrollment. Subjects who have received radiation to the spine, pelvis, ribs, or
femur should be discussed with the sponsor, as extensive radiation to marrow forming
region may compromise a subject's ability to tolerate myelosuppressive chemotherapy.
Subjects who have ongoing radiotherapy-related toxicities are not eligible.

- Subjects who participated in any other study in which receipt of an investigational
study drug occurred within 28 days or 5 half-lives (whichever is longer) prior to
first dose.

- Current or previous other malignancy within 2 years of study entry, except cured
basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of
the cervix, or other noninvasive malignancy without sponsor approval.

- 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.

- Unwilling to be transfused with blood components.

- Known history of Hepatitis B or C infection or HIV infection.

Type of Study:


Study Design:

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

Outcome Measure:

Adverse events that are defined as dose limiting toxicities occurring in the first 28 days of treatment.

Outcome Description:

Subjects will be assigned into cohorts, starting with Dose Level 0 in one of two treatment regimens, and escalating or de-escalating according to protocol criteria

Outcome Time Frame:

Approximately 28 days

Safety Issue:


Principal Investigator

Lance Leopold, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Incyte Corporation


United States: Food and Drug Administration

Study ID:

INCB 18424-144



Start Date:

April 2013

Completion Date:

July 2014

Related Keywords:

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



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