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A Study of BBI608 in Combination With Standard Chemotherapies in Adult Patients With Pancreatic Cancer

NCT02231723 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 139

Last updated 2023-11-18

No results posted yet for this study

Summary

This is an open label, multi-center, multi-arm, dose-escalation study of BBI608 administered in combination with Gemcitabine and nab-Paclitaxel, mFOLFIRINOX, FOLFIRI, or MM-398 with 5-FU and leucovorin.

Conditions

  • Metastatic Pancreatic Adenocarcinoma

Interventions

DRUG

BBI608

Administered continuously twice daily with doses separated by 12 hours

DRUG

Nab-paclitaxel

Nab-paclitaxel 125 mg/m\^2 I.V. infusion on Days 1, 8, and 15 of every 28-day cycle

DRUG

Gemcitabine

Gemcitabine 1000 mg/m\^2 I.V. infusion on Days 1, 8, and 15 of every 28-day cycle

DRUG

Oxaliplatin

Oxaliplatin 85 mg/m\^2 I.V. infusion on Days 1 and 15 of every 28-day cycle

DRUG

Leucovorin

Arm C, D: Leucovorin 400 mg/m\^2 I.V. infusion on Days 1 and 15 of every 28-day cycle

DRUG

Irinotecan

Arm B: Irinotecan 165 mg/m\^2 I.V. infusion on Days 1 and 15 of every 28-day cycle, Arm C: Irinotecan 165 mg/m\^2 I.V. infusion on Days 1 and 15 of every 28-day cycle

DRUG

Fluorouracil

Arm B, D: Fluorouracil 2400 mg/m\^2 I.V. infusion on Days 1 and 15 of every 28-day cycle, Arm C: Fluorouracil 400 mg/m\^2 I.V. bolus followed by 2400 mg/m\^2 I.V. infusion on Days 1 and 15 of every 28-day cycle

DRUG

MM-398

MM-398 70 mg/m\^2 I.V. infusion on Days 1 and 15 of every 28-day cycle

Sponsors & Collaborators

  • Sumitomo Pharma America, Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2020-06-30
Completion
2020-06-30

Countries

  • United States

Study Locations

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Entities

Drugs

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 NCT02231723 on ClinicalTrials.gov