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ARQ-761 Treatment With Gemcitabine/Nab-Paclitaxel Chemotherapy In Pancreatic Cancer

NCT02514031 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2022-06-03

No results posted yet for this study

Summary

This is a study of ARQ-761 (beta-lapachone) with gemcitabine/nab-paclitaxel chemotherapy in subjects with advanced (metastatic, unresectable, or recurrent) pancreatic cancer that has not been treated with gemcitabine.

Conditions

Interventions

DRUG

ARQ-761

Dose Level 1: ARQ761 195 mg IV D1, D15 Gemcitabine 1000 mg/m2 D1, 8, 15 Nab paclitaxel 125 mg/m2 D1, 8, 15 Dose Level 2: ARQ761 290 mg IV D1, D15 Gemcitabine 1000 mg/m2 D1,8,15 Dose Level 3: ARQ761 390 mg IV D1, D15 Gemcitabine 1000 mg/m2 D1,8,15 Nab-paclitaxel 125 mg/m2 D1,8,15 Expansion Dose Level: ARQ761 390 IV mg or as tolerated D1, 15 Gemcitabine 1000 mg/m2 D1,8,15 Nab-Paclitaxel 125 mg/m2 D1,8,15

DRUG

Gemcitabine

Therapy after lead in Phase: You will receive Gemcitabine (1000mg/m2) administered intravenously on Days 1,8, 15-every 28 days. All cycles are 28 days in duration and there are no rest periods between cycles. You may continue treatment after cycle 6 until disease progression.

DRUG

nab-paclitaxel

Therapy after lead in phase: You will receive nab-paclitaxel (125 mg/m2) administered intravenously on Days 1,8, 15-every 28 days. All cycles are 28 days in duration and there are no rest periods between cycles. You may continue treatment after cycle 6 until disease progression.

Sponsors & Collaborators

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • Muhammad Beg, MD · University of Texas Southwestern Medical Center

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-24
Primary Completion
2018-05-22
Completion
2022-05-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

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 NCT02514031 on ClinicalTrials.gov