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NCT01933932 · ClinicalTrials.gov registry record · Phase 3
Assess Efficacy & Safety of Selumetinib in Combination With Docetaxel in Patients Receiving 2nd Line Treatment for v-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Positive NSCLC
A Phase 3 study of Locally Advanced or Metastatic Non Small Cell Lung Cancer Stage IIIb - IV, sponsored by AstraZeneca.
- Active
- Registry status
- Phase 3
- Development phase
- 510
- Enrollment target
- 20
- Study locations
NCT01933932 is a Phase 3 study of Locally Advanced or Metastatic Non Small Cell Lung Cancer Stage IIIb - IV that is active but no longer recruiting, run by AstraZeneca. The registered enrollment target is 510 participants. The trial reports 20 study locations across 13 states.
The verdict
NCT01933932, a Phase 3 study of Locally Advanced or Metastatic Non Small Cell Lung Cancer Stage IIIb - IV, is active but no longer recruiting, sponsored by AstraZeneca.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 510 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to assess the efficacy of selumetinib in combination with docetaxel (75mg/m2) vs placebo in combination with docetaxel (75mg/m2) in patients with locally advance or metastatic NSCLCs that harbor mutations of KRAS. This study will also assess the PK, safety, patient reported outcomes (PRO) and tolerability profile of the selumetinib/docetaxel combination, compared to placebo in combination with docetaxel
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Docetaxel
- DRUG Selumetinib
- DRUG Pegylated G-CSF
Study Locations (20)
Massachusetts
- Research Site - Boston
- Research Site - Boston
- Research Site - Danvers
Other
- Research Site - Buenos Aires
- Research Site - Ciudad de Buenos Aires
- Research Site - Ciudad de Buenos Aires
New York
- Research Site - New York
- Research Site - New York
Pennsylvania
- Research Site - Hershey
- Research Site - Philadelphia
Tennessee
- Research Site - Nashville
- Research Site - Nashville
Colorado
- Research Site - Aurora
Florida
- Research Site - Pembroke Pines
Georgia
- Research Site - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 510 participants |
| Start Date | 2013-09-25 |
| Est. Completion | 2025-12-31 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01933932
The ClinicalTrials.gov registry entry for NCT01933932 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 510 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Locally Advanced or Metastatic Non Small Cell Lung Cancer Stage IIIb - IV appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT01933932 reports 20 study locations spanning 13 distinct geographic areas - top geographies include Massachusetts, Other, New York.
Frequently Asked Questions
What is clinical trial NCT01933932 about?
NCT01933932 is a clinical study titled "Assess Efficacy & Safety of Selumetinib in Combination With Docetaxel in Patients Receiving 2nd Line Treatment for v-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Positive NSCLC". The purpose of this study is to assess the efficacy of selumetinib in combination with docetaxel (75mg/m2) vs placebo in combination with docetaxel (75mg/m2) in patients with locally advance or metastatic NSCLCs that harbor mutations of KRAS. This study will also assess the PK, safety, patient repor...
What is the current status of trial NCT01933932?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 510 participants. The study started on 2013-09-25. Estimated completion is 2025-12-31.
What conditions does trial NCT01933932 study?
This clinical trial studies the following conditions: Locally Advanced or Metastatic Non Small Cell Lung Cancer Stage IIIb - IV.
What interventions are being tested in trial NCT01933932?
The interventions under investigation include: Placebo (DRUG), Docetaxel (DRUG), Selumetinib (DRUG), Pegylated G-CSF (DRUG).
Who is sponsoring clinical trial NCT01933932?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01933932 being conducted?
This trial has 20 study locations across Colorado, Florida, Georgia, Illinois, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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