A Phase 2a/2b Multicenter, Open-Label Study to Evaluate NKTR 102 (PEG-Irinotecan) in Combination With Cetuximab Versus Irinotecan in Combination With Cetuximab in Second Line Colorectal Cancer Patients - Full Text View

Sponsored by:	Nektar Therapeutics
Information provided by:	Nektar Therapeutics
ClinicalTrials.gov Identifier:	NCT00598975

Purpose

Study 07-PIR-02 is a Phase 2 study designed to evaluate the safety and efficacy of NKTR-102 (PEG-irinotecan) for the treatment of patients with colorectal cancer (CRC). The study is comprised of two sequential components - Phase 2a and Phase 2b. The Phase 2a portion is an open-label, dose-finding trial in multiple solid tumor types that are refractory to standard curative or palliative therapies. The Phase 2b portion is an open-label, randomized, two-arm study in patients with second-line metastatic colorectal cancer and study participants will be randomized (1:1) to receive either NKTR-102 and cetuximab or irinotecan and cetuximab. The primary endpoint of the Phase 2b trial is progression-free survival. Secondary endpoints include response rate, response duration, overall survival, standard pharmacokinetics, and incidence of toxicities, including diarrhea and neutropenia.

Phase 2a part of this study is currently active with sites in the US. The Phase 2b part of the study is expected to begin mid-year 2008 and will be conducted in over 40 centers in the US and internationally.

The following entries reflect the currently active Phase 2a portion of this study only.

Condition	Intervention	Phase
Tumor Colorectal Cancer	Drug: NKTR-102 + Cetuximab	Phase II

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: Irinotecan Irinotecan hydrochloride Cetuximab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Multicenter, Open-Label, Phase 2 Study to Determine the Dose, Safety and Efficacy of NKTR 102 in Combination With Cetuximab Versus Irinotecan in Combination With Cetuximab in Second Line, Irinotecan and Cetuximab Naïve Colorectal Cancer Patients With Metastatic or Locally Advanced Disease

Further study details as provided by Nektar Therapeutics:

Primary Outcome Measures:

Establish the recommended Phase 2a dose (RPTD) of the combination of NKTR-102 and cetuximab [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety, pharmacokinetics, and tumor response of NKTR-102 in combination with cetuximab. [ Time Frame: Indefinite ] [ Designated as safety issue: No ]

Estimated Enrollment:	36
Study Start Date:	January 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental NKTR-102 + Cetuximab	Drug: NKTR-102 + Cetuximab Drug: NKTR-102 + Cetuximab

Eligibility

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

Criteria

Inclusion Criteria:

Male and non-pregnant, non-lactating female patients with an ECOG performance score <3 who have any type of solid tumor refractory to standard therapy and who have adequate bone marrow and organ function at screening.

Exclusion Criteria:

Patients must not have used any CYP3A4 inducers or inhibitors with 2 weeks prior to the first day of study drug treatment.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00598975

Contacts

Contact: Dennis Gribben

650-631-3100

Locations

United States, Arizona
TGen Clinical Research Services @ Scottsdale Healthcare, Debi & Jerry Bisgrove Research Pavilion	Recruiting
Scottsdale, Arizona, United States, 85258
Contact: Joyce Ingrid, RN, MSN, OCN 480-323-1339 jingold@shc.org
Principal Investigator: Ramesh Ramanathan, M.D.
United States, Kentucky
Louisville Oncology Clinical Research Program	Recruiting
Louisville, Kentucky, United States, 40202
Contact: Justin Utz 502-629-3607 justin.utz@nortonhealthcare.org
Principal Investigator: John T Hamm, M.D.
United States, Texas
Tyler Cancer Center	Recruiting
Tyler, Texas, United States, 75702
Contact: Linda Dunklin 903-579-9800 linda.dunklin@usoncology.com
Principal Investigator: Don Richards, MD
Texas Oncology - Baylor Sammons Cancer Center	Recruiting
Dallas, Texas, United States, 75426
Contact: Ben Garcia, Supervisor, Clinical Research 214 370 1949 Ben.Garcia@usoncology.com
Principal Investigator: Carlos Becerra, MD

Sponsors and Collaborators

Nektar Therapeutics

Investigators

Study Director:

Jackie Walling, M.D.

Nektar Therapeutics

More Information

Responsible Party:	Nektar Therapeutics ( Dennis Gribben )
Study ID Numbers:	07-PIR-02
Study First Received:	January 11, 2008
Last Updated:	May 1, 2008
ClinicalTrials.gov Identifier:	NCT00598975
Health Authority:	United States: Food and Drug Administration

Keywords provided by Nektar Therapeutics:

Phase 2a: Multiple solid tumor types
Phase 2b: Second-Line Colorectal Cancer (CRC)

Study placed in the following topic categories:

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

Gastrointestinal Neoplasms
Intestinal Diseases
Rectal Diseases
Intestinal 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 14, 2009