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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:
Information provided by (Responsible Party):
Nektar Therapeutics
ClinicalTrials.gov Identifier:
NCT00598975
First received: January 11, 2008
Last updated: August 12, 2014
Last verified: August 2014

January 11, 2008
August 12, 2014
January 2008
May 2009   (final data collection date for primary outcome measure)
Establish the recommended Phase 2a dose (RPTD) of the combination of NKTR-102 and cetuximab [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Establish the RPTD of the combination of NKTR-102 and cetuximab [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00598975 on ClinicalTrials.gov Archive Site
Safety, pharmacokinetics, and tumor response of NKTR-102 in combination with cetuximab. [ Time Frame: Indefinite ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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
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

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.

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Tumor
  • Colorectal Cancer
Drug: NKTR-102 + Cetuximab
Drug: NKTR-102 + Cetuximab
Experimental: NKTR-102 100 mg/m2 + Cetuximab
NKTR-102 100 mg/m2 + Cetuximab
Intervention: Drug: NKTR-102 + Cetuximab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
May 2009
May 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00598975
07-PIR-02
No
Nektar Therapeutics
Nektar Therapeutics
Not Provided
Study Director: Ivan Gergel, M.D. Nektar Therapeutics
Nektar Therapeutics
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP