NKTR-102 in Combination With Cetuximab in Patients With Refractory Solid Tumors (Phase 2a) and Metastatic or Locally Advanced Colorectal Cancer (Phase 2b)

PHASE2CompletedINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

February 29, 2008

Primary Completion Date

May 31, 2009

Study Completion Date

December 31, 2011

Conditions
TumorColorectal Cancer
Interventions
DRUG

NKTR-102 100 mg/m2

"NKTR-102 100 mg/m2 + Cetuximab Arm:~All patients received NKTR-102 in combination with cetuximab. NKTR-102 was administered intravenously (IV) once every 3 weeks (q3w) over 90 minutes on Day 1. Patients were to be enrolled in one of the following sequential dosing cohorts of NKTR-102: 100, 125, 150, or 175 mg/m2. Only the 100 and 125 mg/m2 were enrolled."

DRUG

NKTR-102 125 mg/m2

"NKTR-102 125 mg/m2 + Cetuximab Arm:~All patients received NKTR-102 in combination with cetuximab. NKTR-102 was administered intravenously (IV) once every 3 weeks (q3w) over 90 minutes on Day 1. Patients were to be enrolled in one of the following sequential dosing cohorts of NKTR-102: 100, 125, 150, or 175 mg/m2. Only the 100 and 125 mg/m2 were enrolled."

DRUG

Cetuximab

Cetuximab was administered once weekly via a 2-hour IV infusion at a starting dose of 400 mg/m2 on Day 1 and subsequently administered weekly at 250 mg/m2 via a 1-hour infusion thereafter.

Trial Locations (4)

40202

Investigator Site - Louisville, Louisville

75426

Investigator Site - Dallas, Dallas

75702

Investigator Site - Tyler, Tyler

85258

Investigator Site - Scottsdale, Scottsdale

Sponsors
All Listed Sponsors
lead

Nektar Therapeutics

INDUSTRY

NCT00598975 - NKTR-102 in Combination With Cetuximab in Patients With Refractory Solid Tumors (Phase 2a) and Metastatic or Locally Advanced Colorectal Cancer (Phase 2b) | Biotech Hunter | Biotech Hunter