MedTrace Logo

Trial of ICM With or Without AZD2281 (Olaparib) in Patients With Advanced Pancreatic Cancer

NCT01296763 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2016-03-22

Study results available
· View outcomes & findings →

Summary

Patients whose pancreatic cancers have defects in the BRCA/Fanconi DNA repair pathway or other defects in homologous repair will have cancers that respond to olaparib when given in combination with the DNA damaging agents, irinotecan, cisplatin, mitomycin C (ICM).

Conditions

Interventions

DRUG

Irinotecan

Irinotecan 70 mg/m2 IV, Days 1 and 8

DRUG

Cisplatin

Cisplatin 25 mg/m2 IV, Days 1 and 8

DRUG

Olaparib (for levels 1 and 5)

Olaparib 100 mg bid oral, Days 1 and 8

DRUG

Olaparib (for dose level 2)

Olaparib 100mg bid oral, Day 1-3, Day 8-10

DRUG

Mitomycin-C

Mitomycin 5 mg/m2 IV, Day 1

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    lead OTHER

Principal Investigators

  • Michael Goggins, MD · Sol Goldman Pancreatic Cancer Research Center, JHMI

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2014-01-31
Completion
2016-02-29

Countries

  • United States

Study Locations

More Related Trials

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 NCT01296763 on ClinicalTrials.gov