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 Calcium Citrovorum factor Folinic acid calcium salt pentahydrate Leucovorin Irinotecan Irinotecan hydrochloride Cetuximab Amplivax

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

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

Locations

United States, Tennessee
Vanderbilt-Ingram Cancer Center	Not yet recruiting
Nashville, Tennessee, United States, 37232
Contact: Emily Chan, MD 615-322-6053
Principal Investigator: Mace Rothenberg, 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

Sponsor Website This link exits the ClinicalTrials.gov site

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:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00719199
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
Colorectal Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

Therapeutic Uses
Enzyme Inhibitors
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009