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

NCT00598975 | Completed Phase 2 Results

• 1 other identifier: 07-PIR-02
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 4

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.

Conditions

Tumor; Colorectal Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of Patients With Dose Limiting Toxicities

  Number of patients with Dose Limiting Toxicities

  12 months

Secondary Outcomes (2)

• Number of Patients With Dose Limiting Toxicities by NCI-CTCAE

  12 months

• Number of Patients With Overall Response

  12 months

Study Arms (2)

NKTR-102 100 mg/m2 + Cetuximab

ACTIVE COMPARATOR

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-102 100 mg/m2; Drug: Cetuximab

NKTR-102 125 mg/m2 + Cetuximab

ACTIVE COMPARATOR

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: NKTR-102 125 mg/m2; Drug: Cetuximab

Interventions

NKTR-102 100 mg/m2 DRUG

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.

Also known as: PEG-Irinotecan

NKTR-102 100 mg/m2 + Cetuximab

NKTR-102 125 mg/m2 DRUG

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.

Also known as: PEG-Irinotecan

NKTR-102 125 mg/m2 + Cetuximab

Cetuximab DRUG

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.

Also known as: Erbitux

NKTR-102 100 mg/m2 + Cetuximab; NKTR-102 125 mg/m2 + Cetuximab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients must not have used any CYP3A4 inducers or inhibitors with 2 weeks prior to the first day of study drug treatment.

Sponsors & Collaborators

• Nektar Therapeutics: lead

Study Sites (4)

Investigator Site - Scottsdale

Scottsdale, Arizona, 85258, United States

Location

Investigator Site - Louisville

Louisville, Kentucky, 40202, United States

Location

Investigator Site - Dallas

Dallas, Texas, 75426, United States

Location

Investigator Site - Tyler

Tyler, Texas, 75702, United States

Location

MeSH Terms

Conditions

Neoplasms; Colorectal Neoplasms

Interventions

etirinotecan pegol; Cetuximab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Limitations and Caveats

None reported.

Results Point of Contact

• Title: Study Director
• Organization: Nektar Therapeutics

medicalaffairs@nektar.com

Study Officials

• Study Director

  Nektar Therapeutics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2008
• First Posted: January 23, 2008
• Study Start: February 1, 2008
• Primary Completion: May 1, 2009
• Study Completion: December 1, 2011
• Last Updated: July 12, 2021
• Results First Posted: June 14, 2021

Record last verified: 2021-07

Locations

US (4)