Clinical trial NCT02005315: A Study of Vantictumab (OMP-18R5) in Combination With Nab-Paclitaxel and Gemcitabine in Previously Untreated Stage IV Pancreatic Cancer
Official title: A Phase 1b Dose Escalation Study of Vantictumab (OMP-18R5) in Combination With Nab-Paclitaxel and Gemcitabine in Patients With Previously Untreated Stage IV Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pancreatic Cancer
Stage IV Pancreatic Cancer
Keywords: Pancreatic Cancer
Stage IV Pancreatic Cancer
Lead sponsor: Mereo BioPharma
Sponsor class: INDUSTRY
First posted: 2013-12-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open-label Phase 1b dose-escalation study to assess the safety, tolerability, and PK of vantictumab when combined with nab-paclitaxel and gemcitabine.

Detailed description: Once the maximum tolerated dose (MTD) or maximum administered dose (MAD) has been determined, up to 10 patients may be enrolled in the cohort-expansion phase to better characterize the safety, tolerability and PK of vantictumab combined with nab-paclitaxel and gemcitabine. Up to approximately 34 patients may be enrolled into the study.

Eligibility criteria: Inclusion Criteria:

* Signed Informed Consent Form
* Age ≥18 years
* Histologically documented Stage IV ductal adenocarcinoma of the pancreas
* Availability of tumor tissue, either archival FFPE or obtained at study entry through fresh biopsy
* ECOG performance status of 0 or 1
* Adequate hematologic and end-organ function
* Evaluable or measurable disease per RECIST v1.1
* For women of childbearing potential and men with partners of childbearing potential, agreement to use two effective forms of contraception

Exclusion Criteria:

* Prior therapy before Day 1 of Cycle 1 for the treatment of Stage IV pancreatic cancer
* Prior adjuvant therapy for the treatment of ductal adenocarcinoma of the pancreas
* Known hypersensitivity to any component of study treatments
* Known brain metastases, uncontrolled seizure disorder, or active neurologic disease

Primary outcomes:
measure: Phase 1b: Safety and tolerability of vantictumab in combination with nab-paclitaxel and gemcitabine in patients with previously untreated Stage IV pancreatic cancer
timeFrame: Subjects will be treated and observed for DLT through the end of the first cycle (Days 0-28)
Secondary outcomes:
measure: Pharmacokinetics (PK) of vantictumab when administered in combination with nab-paclitaxel and gemcitabine to patients with previously untreated Stage IV pancreatic cancer
timeFrame: Vantictumab will be administered IV on Days 1 and 15 of each 28-day cycle. Nab-paclitaxel and gemcitabine will be administered IV on Days 1, 8, and 15 of each cycle.
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC/Norris Comprehensive Cancer Center
state: California
city: Aurora
country: United States
facility: University of Colorado Hospital Anschutz Cancer Pavillion
state: Colorado
city: Indianapolis
country: United States
facility: Indiana University Simon Cancer Center
state: Indiana
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Indiana University Institutional Review Board (IRB)
name: Romnee Clark, MD
role: PRINCIPAL_INVESTIGATOR
References: