Clinical trial NCT00598975: NKTR-102 in Combination With Cetuximab in Patients With Refractory Solid Tumors (Phase 2a) and Metastatic or Locally Advanced Colorectal Cancer (Phase 2b)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Tumor
Colorectal Cancer
Keywords: Phase 2a: Multiple solid tumor types
Phase 2b: Second-Line Colorectal Cancer (CRC)
Lead sponsor: Nektar Therapeutics
Sponsor class: INDUSTRY
First posted: 2008-01-23
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 portion of the study was not completed.

Eligibility 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.

Primary outcomes:
measure: Number of Patients With Dose Limiting Toxicities
timeFrame: 12 months
Secondary outcomes:
measure: Number of Patients With Dose Limiting Toxicities by NCI-CTCAE
timeFrame: 12 months
measure: Number of Patients With Overall Response
timeFrame: 12 months
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Investigator Site - Scottsdale
state: Arizona
city: Louisville
country: United States
facility: Investigator Site - Louisville
state: Kentucky
city: Dallas
country: United States
facility: Investigator Site - Dallas
state: Texas
city: Tyler
country: United States
facility: Investigator Site - Tyler
state: Texas
Study officials:
affiliation: Nektar Therapeutics
name: Study Director
role: STUDY_DIRECTOR
References: