Advanced/Metastatic, Pancreatic Cancer

An Open-Label Study of Ruxolitinib given with Chemotherapy in Patients with Advanced Solid Tumors

Incyte Study ID:
INCB 18424-144
CT.gov ID:
NCT01822756
Eudra ID:
N/A
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
1.855.463.3463
Other
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Clinical Study Purpose

This is a study of ruxolitinib in combination with gemcitabine with or without nab-paclitaxel administered to patients with advanced or metastatic pancreatic cancer. The study will be conducted in two parts.

Part 1 of the study will evaluate the safety, tolerability and pharmacokinetics (PK) of ruxolitinib when given as described to patients with advanced or metastatic pancreatic cancer. A goal of Part 1 will be to identify the maximally tolerated dose (MTD) of ruxolitinib when given with gemcitabine with or without nab-paclitaxel. This dose will be selected for use in Part 2 of the study.

Part 2 of the study will further evaluate the safety, tolerability, PK and preliminary clinical activity of ruxolitinib at the dose defined in Part 1 used in combination with gemcitabine with or without nab-paclitaxel in subjects with advanced or metastatic pancreatic cancer.

After multiple challenges of trial conduct, by mutual agreement between investigators and sponsor, dose escalation ended after Cohort B1, RUX 10 mg twice daily (BID) – GCSF in October 2014. Therefore, the MTD was not reached. No safety issues led to the decision to stop further enrollment.

Because of the early study termination, samples for pharmacokinetics and pharmacodynamics, and computed tomography for tumor burden were collected, but not analyzed; analysis data are not available. The data cutoff for this posting is 22 SEP 2015. As of the data cutoff, 1 subject was receiving treatment in the study and had been enrolled for 47 weeks. This subject had their end of treatment visit in AUG 2016. A comparison of this subjects' safety data after the cutoff date showed no clinically meaningful differences (eg, adverse events) compared with safety results that are summarized here.

Clinical Study Summary

MEDICAL CONDITION(S)
  • Advanced/Metastatic
  • Pancreatic Cancer
    • PRODUCT
  • Drug: ruxolitinib
  • Drug: gemcitabine
  • Drug: nab-paclitaxel
  • Drug: filgrastim
    • COLLABORATORS
    N/A
    DATE
    Apr 2013 - Sep 2015
    TYPE
    Interventional
    PHASE
    Phase 1
    SEX
    Female & Male
    AGE
    18+ years
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Clinical Study Locations

    Name
    Contact Us
    Name
    Nashville, TN, US
    Name
    Sarasota, FL, US
    Name
    Birmingham, AL, US
    Name
    Gainesville, FL, US
    Name
    Durham, NC, US

    Key Inclusion and Exclusion Criteria

    Inclusion Criteria

    • Male or female, 18 years or older
    • Histologically or cytologically confirmed adenocarcinoma of the pancreas

    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 uncontrolled brain metastases or history of uncontrolled seizures.

    Protocol Summary

    Incyte Study ID:
    INCB 18424-144
    Primary Purpose:
    Treatment
    Allocation:
    Non-randomized
    Study Design:
    Single Group Assignment
    Masking:
    None (Open Label)
    Interventions:
    Drug
    Enrollment:
    42
    Primary Outcome
    Open
    Secondary Outcome
    Open