Study of Irinotecan Plus Cetuximab Plus IMO-2055 in Patients With Colorectal Cancer - Full Text View

Sponsored by:	Idera Pharmaceuticals, Inc.
Information provided by:	Idera Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00719199

Purpose

Open-label phase 1b trial. Study treatment will be administered in 3 week cycles.

There are two distinct parts in this study:

Part 1: Dose escalation from IMO-2055
Part 2: Once a recommended phase 2 dose is found additional tolerability and pharmacodynamics will be explored

Condition	Intervention	Phase
Colorectal Cancer	Drug: IMO-2055 Drug: Cetuximab Drug: irinotecan	Phase I

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: Leucovorin Citrovorum factor Irinotecan U 101440E Irinotecan hydrochloride Cetuximab Amplivax Leucovorin Calcium Folinic acid calcium salt pentahydrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	Open-Label Phase 1b Study of Irinotecan Plus Cetuximab Plus IMO-2055 in Patients With Colorectal Cancer Who Have Progressed Following Chemotherapy for Advanced or Metastatic Disease

Further study details as provided by Idera Pharmaceuticals, Inc.:

Primary Outcome Measures:

To determine the recommended phase 2 dose of IMO-2055 when combined with irinotecan and cetuximab. [ Time Frame: Throughout Study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To evaluate the safety of weekly IMO-2055 combined with irinotecan plus cetuximab. [ Time Frame: throughout Study ] [ Designated as safety issue: Yes ]
To investigate the pharmacokinetics (PK) of IMO-2055, cetuximab, and irinotecan. [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	50
Study Start Date:	September 2008
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental IMO 2055 is a novel phosphorothioate oligodeoxynucleotide that is an agonist of Toll-like Receptor 9 (TLR9).	Drug: IMO-2055 SC weekly injections Drug: Cetuximab given weekly through intravenous administration. Cycle 1 Day 1 dose given at 400mg/m2, all subsequent doses given at 250 mg/m2. Drug: irinotecan given weekly through intravenous administration at a dose of 300 mg/m2.

Detailed Description:

Part 1: Dose escalation of IMO-2055, including 4 dose groups. Once a recommended phase 2 dosage (RP2D) of IMO-2055 given concomitantly with irinotecan and cetuximab is found the selected cohort will be expanded by an additional 6 to 9 patients (to a total of 12 patients) for confirmation of the RP2D and combination treatment regimen.
Part 2: A final cohort of 12 patients (Cohort 6) will be enrolled simultaneously to explore tolerability and pharmacodynamics in patients treated with the RP2D of IMO-2055 in combination with irinotecan with cetuximab.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologically confirmed adenocarcinoma of the colon or rectum with metastatic disease.
Patients whose disease has recurred or progressed during or within 6 months of completion of standard therapy or patients stopping standard therapy due to excessive toxicity within the first 8 weeks.
One additional prior regimen is permitted for neoadjuvant, adjuvant, or neoadjuvant plus adjuvant therapy.

Exclusion Criteria:

Administration of any chemotherapy, biotherapy, radiotherapy, investigational agent or major surgery, within 4 weeks prior to first study dosing.
Inadequate bone marrow, liver, and renal function
Other significant medical diseases

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00719199

Contacts

Contact: Kelley Bemis

609-799-7580 ext 405

kbemis@theradex.com

Locations

United States, Tennessee
Vanderbilt-Ingram Cancer Center	Recruiting
Nashville, Tennessee, United States, 37232
Contact: Teresa Knoop, MD 615-936-5847 teresa.knoop@vanderbilt.edu
Principal Investigator: Emily Chan, MD
United States, Texas
Cancer Therapy & Research Center	Recruiting
San Antonio, Texas, United States, 78229
Contact: Monica Mita, MD 210-450-1797 MITAM@UTHSCSA.EDU
Principal Investigator: Monica Mita, MD

Sponsors and Collaborators

Idera Pharmaceuticals, Inc.

More Information

Additional Information:

Sponsor Website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Idera Pharmaceuticals Inc ( Alice Bexon MBChB, MD/Vice President, Clinical Development )
Study ID Numbers:	IMO-2055-210
Study First Received:	July 17, 2008
Last Updated:	March 3, 2009
ClinicalTrials.gov Identifier:	NCT00719199 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Idera Pharmaceuticals, Inc.:

Colorectal cancer
metastatic cancer
prior therapy
1b

Study placed in the following topic categories:

Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Irinotecan
Cetuximab
Leucovorin
Intestinal Diseases

Rectal Diseases
Intestinal Neoplasms
Digestive System Diseases
Neoplasm Metastasis
Gastrointestinal Neoplasms
Antineoplastic Agents, Phytogenic
Colorectal Neoplasms

Additional relevant MeSH terms:

Digestive System Neoplasms
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Gastrointestinal Diseases
Colonic Diseases
Irinotecan
Cetuximab
Enzyme Inhibitors
Intestinal Diseases
Rectal Diseases

Pharmacologic Actions
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Digestive System Diseases
Therapeutic Uses
Gastrointestinal Neoplasms
Antineoplastic Agents, Phytogenic
Colorectal Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009