Phase 2
Completed N=18
NKTR-102 in Combination With Cetuximab in Patients With Refractory Solid Tumors (Phase 2a) and Metastatic or Locally Advanced Colorectal Cancer (Phase 2b)
Source: ClinicalTrials.gov NCT00598975 ↗Enrolled (actual)
18
Serious AEs
44.4%
Results posted
Jun 2021
Primary outcomePrimary: Number of Patients With Dose Limiting Toxicities — 0; 1; 1; 1 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Dose Limiting Toxicities |
0; 1; 1; 1; 1; 2 | — |
| SECONDARY Number of Patients With Dose Limiting Toxicities by NCI-CTCAE |
0; 1; 1; 0; 1; 1 | — |
| SECONDARY Number of Patients With Overall Response |
0; 0; 0; 3; 0; 3 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00598975). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.