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NKTR-102 100 mg

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

Ensayo de NEKTAR THERAPEUTICS en Tumor · Colorectal Cancer (del registro, en inglés).

Más ensayos de: Cáncer colorrectal.

Fase

Fase 2

Estado

Completado

Participantes

18

previstos

Centros

4

Fin del objetivo primario

may 2009

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, no aleatorizado, abierto. Comenzó en feb 2008.

Qué mide

Number of Patients With Dose Limiting Toxicities (del registro, en inglés) (12 meses)

Cómo lo describe el promotor

En el documentoEn inglés, del registroStudy 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.

Más ensayos de NKTR

Todos los de NKTR, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT00598975), actualizada en jul 2021.