NCT00912743

Brief Summary

This study is being carried out to see if the new drug, olaparib (AZD2281), can effectively and safely treat advanced large bowel cancer. The primary goal of this clinical trial is to determine whether olaparib will have a beneficial effect on the patient's cancer by causing a response and increasing the time it takes for the cancer to progress.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for phase_2 colorectal-cancer

Timeline
Completed

Started May 2009

Geographic Reach
1 country

8 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

May 1, 2009

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

May 28, 2009

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 3, 2009

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
4.7 years until next milestone

Results Posted

Study results publicly available

November 9, 2016

Completed
Last Updated

November 9, 2016

Status Verified

September 1, 2016

Enrollment Period

2.8 years

First QC Date

May 28, 2009

Results QC Date

January 13, 2015

Last Update Submit

September 22, 2016

Conditions

Colorectal Cancer

Keywords

Colorectal cancerOlaparibMSI statusStage IVMeasurable Colorectal CancerStratified by MSI Status

Outcome Measures

Primary Outcomes (1)

  • Tumour Response

    Tumour response is the number of patients who experienced complete or partial response at least once during the assessment period, according to the definitions of Response Evaluation Criteria In Solid Tumours (RECIST version 1.1)

    From baseline, i.e. up to 28 days before first study drug dose, and then every 2 cycles (8 weeks) up to objective disease progression by RECIST, assessed up to 35 months

Secondary Outcomes (2)

  • Progression Free Survival

    From baseline, i.e. up to 28 days before first study drug dose, and then every 2 cycles (8 weeks) up to objective disease progression by RECIST, assessed up to 35 months

  • Overall Survival

    Survival follow-up from first dose till death of the patient or till end of study in absence of death, assessed up to 35 months

Study Arms (1)

1

EXPERIMENTAL

MSI - H arm

Drug: olaparib

Interventions

olaparibDRUG

400 mg po bid continuously

1

Eligibility Criteria

Age18 Years - 130 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients will have measurable disseminated colorectal cancer that is incurable by surgery
  • Patients will have had tumor progression following standard combination front-line or second-line chemotherapy.
  • CRC patients who have relapsed or recurrent disease within six months after completing adjuvant or neoadjuvant chemotherapy

You may not qualify if:

  • Previous treatment with PARP inhibitors, including olaparib.
  • Patients with symptomatic, uncontrolled brain metastases.
  • Patients receiving any chemotherapy, radiotherapy (except for palliative reasons), within 4 weeks from the last dose prior to study entry (or a longer period depending on the defined characteristics of the agents used).
  • Patients who are unable to swallow orally administered medication.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Research Site

Los Angeles, California, United States

Location

Research Site

Palm Springs, California, United States

Location

Research Site

Aurora, Colorado, United States

Location

Research Site

Newark, Delaware, United States

Location

Research Site

New York, New York, United States

Location

Research Site

Philadelphia, Pennsylvania, United States

Location

Research Site

Nashville, Tennessee, United States

Location

Research Site

Seattle, Washington, United States

Location

Related Links

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

olaparib

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Results Point of Contact

Title
Angela Sawyer, Clinical Delivery Director
Organization
Astra Zeneca LLP
angele.sawyer@astrazeneca.com
+44 1625 512397

Study Officials

  • Lawrence P Leichman, MD

    Aptium Oncology Gastrointestinal Cancer Consortium

    PRINCIPAL INVESTIGATOR

  • Bert H O'Neil, MD

    Aptium Oncology Gastrointestinal Cancer Consortium

    PRINCIPAL INVESTIGATOR

  • Jane Robertson, BSc, MBCHB, MD

    AstraZeneca

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2009

First Posted

June 3, 2009

Study Start

May 1, 2009

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

November 9, 2016

Results First Posted

November 9, 2016

Record last verified: 2016-09

Locations

US(8)