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NCT00598975 · ClinicalTrials.gov registry record · Phase 2
NKTR-102 in Combination With Cetuximab in Patients With Refractory Solid Tumors (Phase 2a) and Metastatic or Locally Advanced Colorectal Cancer (Phase 2b)
A Phase 2 study, sponsored by Nektar Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 18
- Enrollment target
NCT00598975 is a Phase 2 study that has completed, run by Nektar Therapeutics. The registered enrollment target is 18 participants.
The verdict
NCT00598975, a Phase 2 study, has completed, sponsored by Nektar Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 18 participants
- Enrollment target
Study 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.
Interventions
- DRUG Cetuximab
- DRUG NKTR-102 100 mg/m2
- DRUG NKTR-102 125 mg/m2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2008-02 |
| Est. Completion | 2011-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00598975
The ClinicalTrials.gov registry entry for NCT00598975 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nektar Therapeutics, which has 37 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Cetuximab is the first listed.
NCT00598975 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00598975 about?
NCT00598975 is a clinical study titled "NKTR-102 in Combination With Cetuximab in Patients With Refractory Solid Tumors (Phase 2a) and Metastatic or Locally Advanced Colorectal Cancer (Phase 2b)". 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 tr...
What is the current status of trial NCT00598975?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 18 participants. The study started on 2008-02. Estimated completion is 2011-12.
What interventions are being tested in trial NCT00598975?
The interventions under investigation include: Cetuximab (DRUG), NKTR-102 100 mg/m2 (DRUG), NKTR-102 125 mg/m2 (DRUG).
Who is sponsoring clinical trial NCT00598975?
This trial is sponsored by Nektar Therapeutics, which has 37 total clinical trials registered on ClinicalTrials.gov.
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