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A Phase 1b/2 Study of OMP-59R5 in Combination With Nab-Paclitaxel and Gemcitabine in Subjects With Previously Untreated Stage IV Pancreatic Cancer


Phase 1/Phase 2
18 Years
90 Years
Open (Enrolling)
Both
Stage IV Pancreatic Cancer

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Trial Information

A Phase 1b/2 Study of OMP-59R5 in Combination With Nab-Paclitaxel and Gemcitabine in Subjects With Previously Untreated Stage IV Pancreatic Cancer


Inclusion Criteria:



Subjects must meet all of the following major inclusion criteria to be eligible for the
study:

1. 18 years of age or older

2. Histologically or cytologically documented stage IV ductal adenocarcinoma of the
pancreas.

3. Performance Status (ECOG) 0 or 1

4. FFPE tumor tissue from metastatic site(s

5. Adequate organ function

6. Written consent on an IRB/IEC-approved Informed Consent Form prior to any
study-specific evaluation.

7. For women of child-bearing potential, negative serum pregnancy test at screening and
use of physician-approved method of birth control from 30 days prior to the first
study drug administration to 30 days following the last study drug administration.

8. Male subjects must be surgically sterile or must agree to use physician-approved
contraception from 30 days prior to the first study drug administration to 30 days
following the last study drug administration.

Exclusion Criteria:

Subjects who meet any of the following major exclusion criteria will not be eligible for
participation in the study:

1. Neuroendocrine tumors (i.e., carcinoid, islet cell cancer) of the pancreas.

2. Known brain metastases.

3. Prior therapy, including systemic therapy, surgical resection or radiation for newly
diagnosed stage IV pancreatic cancer.

4. Presence of any serious or unstable concomitant systemic disorder incompatible with
the clinical study (e.g., substance abuse, uncontrolled intercurrent illness
including active infection, arterial thrombosis, symptomatic pulmonary embolism).

5. Any disorder that would significantly compromise protocol compliance.

6. Prior non-pancreatic malignancy treated with chemotherapy. Prior malignancies
treated with surgery and/or radiotherapy alone must be in remission ≥3 years. The
following prior malignancies are allowable irrespective of when they occurred: in
situ carcinoma of the cervix, in situ ductal breast cancer, low-grade local bladder
cancer, and nonmelanotic skin cancer.

7. Known human immunodeficiency virus (HIV) infection.

8. Females who are pregnant or breastfeeding.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Dose limiting toxicities (DLT) of OMP-59R5 in combination with nab-paclitaxel and gemcitabine

Outcome Description:

The maximum tolerated dose (MTD) will be determined in patients treated with OMP-59R5 in combination with nab-paclitaxel and gemcitabine

Outcome Time Frame:

Subjects will be treated and observed for DLT through the end of the first cycle (28 days)

Safety Issue:

Yes

Principal Investigator

Eileen M O'Reilly, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

59R5-002

NCT ID:

NCT01647828

Start Date:

October 2012

Completion Date:

September 2016

Related Keywords:

  • Stage IV Pancreatic Cancer
  • Newly diagnosed Stage IV Pancreatic Cancer
  • Pancreatic Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Greenville Hospital SystemGreenville, South Carolina  29605
Rocky Mountain Cancer CentersThornton, Colorado  80260
Duke University Medical CenterDurham, North Carolina  27710
Bend Memorial ClinicBend, Oregon  97701
Sarah Cannon Research InstituteNashville, Tennessee  37203
South Texas Accelerated Research Thereapeutics, LLC (START)San Antonio, Texas  78229