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Phase I Trial of LCL161 and Gemcitabine Plus Nab-Paclitaxel in Metastatic Pancreatic Cancer

NCT01934634 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2015-11-10

No results posted yet for this study

Summary

The goal of this study is to identify the maximum tolerated dose and dose-limiting side effects of LCL161 in combination with gemcitabine and nab-paclitaxel and to provide safety data in patients with measurable metastatic pancreatic cancer.

Conditions

Interventions

DRUG

LCL161

LCL161 (tablets): 300, 600, 1200, or 1800 mg once a week (Day 1, 8, 15) for 3 weeks, every 28 days

DRUG

Gemcitabine

Gemcitabine IV: 1,000 mg/m2 once a week (Day 1, 8, 15) for 3 weeks, every 28 days

DRUG

nab-Paclitaxel

nab-paclitaxel IV: 125 mg/m2 once a week (Day 1, 8, 15) for 3 weeks, every 28 days

Sponsors & Collaborators

  • Novartis Pharmaceuticals

    collaborator INDUSTRY

  • Delta Clinical Research, LLC

    collaborator INDUSTRY

  • US Oncology Research

    lead INDUSTRY

Principal Investigators

  • Yvonne M. Coyle, MD · US Oncology Research, McKesson Specialty Health

  • Carlos H. Becerra, MD · US Oncology Research, McKesson Specialty Health

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2016-03-31

Countries

  • United States

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01934634 on ClinicalTrials.gov