NKTR-102 in Combination With Cetuximab in Patients With Refractory Solid Tumors (Phase 2a) and Metastatic or Locally Advanced Colorectal Cancer (Phase 2b)
Condition: Tumor; Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: NKTR-102 100 mg/m2; NKTR-102 125 mg/m2; Cetuximab
Intervention description: 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.; 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.; 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.
Intervention MeSH terms: Irinotecan; Cetuximab; Etirinotecan pegol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Phase 2a: Multiple solid tumor types; Phase 2b: Second-Line Colorectal Cancer (CRC)

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.
    

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.