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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Tumor, Colorectal Cancer

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Establish the recommended Phase 2a dose (RPTD) of the combination of NKTR-102 and cetuximab

Outcome Time Frame:

12 months

Safety Issue:

No

Principal Investigator

Daniel Maslyar, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Nektar Therapeutics

Authority:

United States: Food and Drug Administration

Study ID:

07-PIR-02

NCT ID:

NCT00598975

Start Date:

January 2008

Completion Date:

Related Keywords:

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

Name

Location

Tyler Cancer CenterTyler, Texas  75702
Louisville Oncology Clinical Research ProgramLouisville, Kentucky  40202
TGen Clinical Research Services @ Scottsdale Healthcare, Debi & Jerry Bisgrove Research PavilionScottsdale, Arizona  85258
Texas Oncology - Baylor Sammons Cancer CenterDallas, Texas  75426