NCT01116271

Brief Summary

The purpose of this study is to determine whether treatment with Selumetinib (AZD6244) (Hyd-Sulfate) in combination with Irinotecan as a second treatment in patients with K-ras or B-raf mutation will prevent tumor progression and prolong progression free survival.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for phase_2 colorectal-cancer

Timeline
Completed

Started Apr 2010

Shorter than P25 for phase_2 colorectal-cancer

Geographic Reach
1 country

12 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

April 1, 2010

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

April 30, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 4, 2010

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

January 14, 2013

Status Verified

January 1, 2013

Enrollment Period

2.3 years

First QC Date

April 30, 2010

Last Update Submit

January 11, 2013

Conditions

Colorectal Cancer

Keywords

colorectalsecond line therapyK-ras or B-raf mutationsresponse rateProgression Free Survival

Outcome Measures

Primary Outcomes (2)

  • Dose Finding will be calculated based upon toxicity screening and dose modification guidelines within protocol.

    AEs will be assessed at each cycle visit, discontinuation treatment visit, and 30 days post last day of study treatment

  • Objective Response Rate will be assessed by the RECIST guideline documented in the European Journal of Cancer, 2009.

    Tumor evaluation via RECIST guidelines will be done on screening visit, day 22 of every other cycle, and treatment discontinuation visit

Secondary Outcomes (3)

  • Safety of combination of Selumetinib (AZD6244) with irinotecan by SAE and AE documentation

    AEs will be assesed at the screening visit, each cycle visit, treatment discontinuation date, and 30 days post last day of study treatment

  • PK of Selumetinib (AZD6244), N-desmethyl Selumetinib(AZD6244) and selumetinib (AZD6244) amide in combination with irinotecan

    PK sample draws will take place on Day 1 and 15 of first cycle

  • Progression Free Survival (PFS) for patients with K-ras or B-raf mutations treated with combination of irinotecan and Selumetinib (AZD6244)

    PFS will be determined via the RECIST guidelines on tumor measurement done on day 22 of every other cycle and on the treatment discontinuation visit

Study Arms (1)

1

EXPERIMENTAL

Selumetinib (AZD6244) in combination with irinotecan

Drug: AZD6244Drug: Irinotecan

Interventions

AZD6244DRUG

50 or 75mg, capsules, PO, BID, 28 days

Also known as: Selumetinib
1
IrinotecanDRUG

180mg/m2, IV, Day 1\& 15 of each cycle

Also known as: Camptosar; Campto
1

Eligibility Criteria

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

You may qualify if:

  • \- Histological or cytological confirmation of advanced or metastatic colorectal cancer with available tissue and tumor sample confirmed as K-ras or B-raf mutation positive. Current failure of 1st line anti-cancer therapy with an oxaliplatin and bevacizumab based regimen or patients relapsing within 12 months of completing adjuvant FOLFOX .

You may not qualify if:

  • \- Treatment within 14 days prior to first study treatment with conventional therapy or treatment within 28 days prior to first study treatment with an investigational drug Prior treatment with a MEK or B-raf inhibitor or any irinotecan-containing regimen Prior treatment with a MEK or B-raf inhibitor or any irinotecan-containing regimen

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

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

New Haven, Connecticut, United States

Location

Research Site

Newark, Delaware, United States

Location

Research Site

Miami Beach, Florida, United States

Location

Research Site

New York, New York, United States

Location

Reserach Site

Chapel Hill, North Carolina, United States

Location

Research Site

Greenville, North Carolina, United States

Location

Research Site

Washington, North Carolina, United States

Location

Research Site

Philadelphia, Pennsylvania, United States

Location

Research Site

Seattle, Washington, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

AZD 6244Irinotecan

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic Compounds

Study Officials

  • Howard Hochster, MD

    Yale University

    PRINCIPAL INVESTIGATOR

  • Lawrence Leichman, MD

    Desert Regional Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

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

April 30, 2010

First Posted

May 4, 2010

Study Start

April 1, 2010

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

January 14, 2013

Record last verified: 2013-01

Locations

US(12)