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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00598975
First Posted: January 23, 2008
Last Update Posted: August 15, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Nektar Therapeutics
  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 primary endpoint of the Phase 2a is to establish the /recommended Phase 2 Dose (RPTD) of NKTR-102 by measuring the frequency of Dose Limiting Toxicity (DLT). 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 portion of the trial is progression-free survival. Secondary endpoints for both the Phase 2a and 2b portion include response rate, response duration, overall survival, standard pharmacokinetics, and incidence of toxicities, including diarrhea and neutropenia.

Condition Intervention Phase
Tumor Colorectal Cancer Drug: NKTR-102 + Cetuximab Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Open-Label, Phase 2 Study to Determine the Dose, Safety and Efficacy of NKTR 102 (PEG-Irinotecan) in Combination With Cetuximab in Patients With Solid Tumors Refractory to Standard Treatment and to Evaluate the Safety and Efficacy of NKTR 102 or Irinotecan in Combination With Cetuximab in Second Line, Irinotecan and Cetuximab Naïve, Colorectal Cancer Patients With Metastatic or Locally Advanced Disease

Resource links provided by NLM:


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 ]

Secondary Outcome Measures:
  • Safety, pharmacokinetics, and tumor response of NKTR-102 in combination with cetuximab. [ Time Frame: Indefinite ]

Enrollment: 18
Study Start Date: January 2008
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NKTR-102 100 mg/m2 + Cetuximab
NKTR-102 100 mg/m2 + Cetuximab
Drug: NKTR-102 + Cetuximab
Drug: NKTR-102 + Cetuximab

Detailed Description:
The Phase 2a portion of this study is completed. The following entries reflect the Phase 2a portion of this study only. The Phase 2b portion of the study was not enrolled. Based on emerging data regarding the corresponding low efficacy of cetuximab in patients with KRAS mutations, as well as revised NKTR-102 clinical development plans, the Phase 2b portionof the study was not completed.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00598975


Locations
United States, Arizona
TGen Clinical Research Services @ Scottsdale Healthcare, Debi & Jerry Bisgrove Research Pavilion
Scottsdale, Arizona, United States, 85258
United States, Kentucky
Louisville Oncology Clinical Research Program
Louisville, Kentucky, United States, 40202
United States, Texas
Texas Oncology - Baylor Sammons Cancer Center
Dallas, Texas, United States, 75426
Tyler Cancer Center
Tyler, Texas, United States, 75702
Sponsors and Collaborators
Nektar Therapeutics
Investigators
Study Director: Ivan Gergel, M.D. Nektar Therapeutics
  More Information

Responsible Party: Nektar Therapeutics
ClinicalTrials.gov Identifier: NCT00598975     History of Changes
Other Study ID Numbers: 07-PIR-02
First Submitted: January 11, 2008
First Posted: January 23, 2008
Last Update Posted: August 15, 2014
Last Verified: August 2014

Keywords provided by Nektar Therapeutics:
Phase 2a: Multiple solid tumor types
Phase 2b: Second-Line Colorectal Cancer (CRC)

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Irinotecan
Cetuximab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action