Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00988169 · ClinicalTrials.gov registry record · Phase 2
Erlotinib and AT-101 in Advanced Non-Small Cell Lung Cancer (NSCLC) Patients With Epidermal Growth Factor Receptor (EGFR) Activating Mutations
A Phase 2 study, sponsored by Memorial Sloan Kettering Cancer Center.
- Terminated
- Registry status
- Phase 2
- Development phase
- 6
- Enrollment target
NCT00988169: Clinical Trial Phase 2 study, sponsored by Memorial Sloan Kettering Cancer Center.
NCT00988169 is a Phase 2 study that was terminated before completion, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 6 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00988169, a Phase 2 study, was terminated before completion, sponsored by Memorial Sloan Kettering Cancer Center.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 6 participants
- Enrollment target
Study Summary
Advanced stage lung cancer is generally treated with anti-cancer medication called chemotherapy. Most lung cancer is caused by cigarette smoking. However, some lung cancers develop in people who never smoked or who only smoked for a short period of time. This type of lung cancer may respond to a medication called erlotinib (Tarceva). Erlotinib is an anticancer pill that is approved by the Food and Drug Administration (FDA) for use in patients with advanced lung cancer. Unfortunately, erlotinib does not work for all patients or only works for a period of time. The doctors are trying to find ways to improve the effect of erlotinib by combining it with another anti-cancer medication. Ascenta Therapeutics, Inc. has developed a drug called AT-101 as a potential treatment for cancer. AT-101 is an investigational drug. That means that AT-101 is not approved by the United States Food and Drug Administration (FDA) for general use. The FDA does permit its use in studies like this one to determine whether it is safe and effective. This is the first study to examine the effects of AT-101 and erlotinib. It is hoped that by combining AT-101 with erlotinib, AT-101 may help erlotinib work better to shrink lung cancer. Studies that have been performed in the laboratory suggest that AT-101 in combination with erlotinib may be more effective at shrinking tumors than erlotinib alone.
Primary Outcome
(CR+PR, by WHO Criteria for Standard Bidimensional Tumor Measurement) After One 21-day Cycle of Combination Therapy With Erlotinib and AT-101
Interventions
- DRUG oral erlotinib and pulsed doses of oral AT-101
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2009-09 |
| Est. Completion | 2010-05 |
| Phase | Phase 2 |
Why NCT00988169 stopped before completion
NCT00988169 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which oral erlotinib and pulsed doses of oral AT-101 is the first listed.
NCT00988169 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00988169 about?
NCT00988169 is a clinical study titled "Erlotinib and AT-101 in Advanced Non-Small Cell Lung Cancer (NSCLC) Patients With Epidermal Growth Factor Receptor (EGFR) Activating Mutations". Advanced stage lung cancer is generally treated with anti-cancer medication called chemotherapy. Most lung cancer is caused by cigarette smoking. However, some lung cancers develop in people who never smoked or who only smoked for a short period of time. This type of lung cancer may respond to a med...
What is the current status of trial NCT00988169?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 6 participants. The study started on 2009-09. Estimated completion is 2010-05.
What interventions are being tested in trial NCT00988169?
The interventions under investigation include: oral erlotinib and pulsed doses of oral AT-101 (DRUG).
Who is sponsoring clinical trial NCT00988169?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00988169's enrollment target sits among peer trials
6 1996th of 2000 higher than 1 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia