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NCT00370383 · ClinicalTrials.gov registry record · Phase 2
A Study Comparing Sequential Satraplatin & Erlotinib to Erlotinib in Unresectable Stage 3/4 Non-small-cell Lung Cancer (NSCLC)
A Phase 2 study, sponsored by Agennix.
- Completed
- Registry status
- Phase 2
- Development phase
- 100
- Enrollment target
NCT00370383: Completed Phase 2 study, sponsored by Agennix.
NCT00370383 is a Phase 2 study that has completed, run by Agennix. The registered enrollment target is 100 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (25% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00370383, a Phase 2 study, has completed, sponsored by Agennix.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 100 participants
- Enrollment target
Study Summary
Patients ≥ 70 years of age with locally advanced unresectable or metastatic non-small cell lung cancer (NSCLC) frequently do not receive systemic cytotoxic chemotherapy due to concerns regarding their inability to tolerate treatment. Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) are agents with favorable toxicity profiles that have shown activity in patients with NSCLC. Erlotinib as a single-agent is currently approved for the treatment of patients with NSCLC whose disease has progressed following one prior course of chemotherapy and is currently being evaluated in NSCLC patients who have not received prior systemic treatment. However, when studied with combination chemotherapy in the first-line setting, continuous daily administration of erlotinib did not result in improved patient survival. Further clinical and in vitro data suggest that the sequencing of cytotoxic chemotherapy with EGFR TKIs is important to maximize their therapeutic potential when administered in combination. Satraplatin is an oral, investigational anticancer drug that is a member of the platinum-based class of chemotherapy drugs. Platinum-based drugs have been clinically proven to be one of the most effective classes of anticancer therapies. Unlike the currently marketed platinum-based drugs, satraplatin can be given orally and is currently being evaluated in a pivotal phase 3 clinical trial as 2nd-line therapy for patients with hormone refractory prostate cancer. The rationale for this study is to develop an active and well-tolerated oral regimen for patients ≥ 70 years of age with NSCLC. Administration of the study drugs will be sequenced with satraplatin administered on days 1-5 and erlotinib on days 8-21 of each 28-day cycle. The primary endpoint will be progression-free survival (PFS). Patients will be randomized to treatment with either the experimental regimen or single-agent continuous erlotinib.
Interventions
- DRUG Erlotinib
- DRUG Satraplatin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2006-07 |
| Est. Completion | 2009-03 |
| Phase | Phase 2 |
What the finished NCT00370383 record still lists
NCT00370383 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (25% lower).
The record links to 0 conditions, and to 2 interventions - of which Erlotinib is the first listed.
NCT00370383 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00370383 about?
NCT00370383 is a clinical study titled "A Study Comparing Sequential Satraplatin & Erlotinib to Erlotinib in Unresectable Stage 3/4 Non-small-cell Lung Cancer (NSCLC)". Patients ≥ 70 years of age with locally advanced unresectable or metastatic non-small cell lung cancer (NSCLC) frequently do not receive systemic cytotoxic chemotherapy due to concerns regarding their inability to tolerate treatment. Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors...
What is the current status of trial NCT00370383?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2006-07. Estimated completion is 2009-03.
What interventions are being tested in trial NCT00370383?
The interventions under investigation include: Erlotinib (DRUG), Satraplatin (DRUG).
Who is sponsoring clinical trial NCT00370383?
This trial is sponsored by Agennix, which has 13 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00370383's enrollment target sits among peer trials
100 672nd of 2000 higher than 1,263 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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