NCT02005315

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P50-P75 for phase_1 pancreatic-cancer

Timeline
Completed

Started Sep 2013

Typical duration for phase_1 pancreatic-cancer

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 3, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 9, 2013

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

September 9, 2020

Status Verified

September 1, 2020

Enrollment Period

4.1 years

First QC Date

December 3, 2013

Last Update Submit

September 7, 2020

Conditions

Pancreatic CancerStage IV Pancreatic Cancer

Keywords

Pancreatic CancerStage IV Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

  • Phase 1b: Safety and tolerability of vantictumab in combination with nab-paclitaxel and gemcitabine in patients with previously untreated Stage IV pancreatic cancer

    The maximum tolerated dose (MTD) will be determined in patients treated with vantictumab in combination with weekly nab-paclitaxel

    Subjects will be treated and observed for DLT through the end of the first cycle (Days 0-28)

Secondary Outcomes (1)

  • Pharmacokinetics (PK) of vantictumab when administered in combination with nab-paclitaxel and gemcitabine to patients with previously untreated Stage IV pancreatic cancer

    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.

Study Arms (3)

Vanctictumab (OMP-18R5)

EXPERIMENTAL

Vantictumab will be administered by intravenous (IV) infusion.

Drug: VantictumabDrug: Nab-PaclitaxelDrug: Gemcitabine

Nab-Paclitaxel

EXPERIMENTAL

Nab-Paclitaxel will be administered by intravenous (IV) infusion.

Drug: VantictumabDrug: Nab-PaclitaxelDrug: Gemcitabine

Gemcitabine

EXPERIMENTAL

Gemcitabine will be administered by intravenous (IV) infusion.

Drug: VantictumabDrug: Nab-PaclitaxelDrug: Gemcitabine

Interventions

VantictumabDRUG

Administered intravenous (IV) infusion.

Also known as: OMP-18R5
GemcitabineNab-PaclitaxelVanctictumab (OMP-18R5)
Nab-PaclitaxelDRUG

Nab-Paclitaxel will be administered by intravenous (IV) infusion.

GemcitabineNab-PaclitaxelVanctictumab (OMP-18R5)
GemcitabineDRUG

Gemcitabine will be administered by intravenous (IV) infusion.

GemcitabineNab-PaclitaxelVanctictumab (OMP-18R5)

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

USC/Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

University of Colorado Hospital Anschutz Cancer Pavillion

Aurora, Colorado, 80045, United States

Location

Indiana University Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

130-nm albumin-bound paclitaxelGemcitabine

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Romnee Clark, MD

    Indiana University Institutional Review Board (IRB)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2013

First Posted

December 9, 2013

Study Start

September 1, 2013

Primary Completion

October 1, 2017

Study Completion

November 1, 2017

Last Updated

September 9, 2020

Record last verified: 2020-09

Locations

US(5)