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NCT01750281 · ClinicalTrials.gov registry record · Phase 2

Assess Efficacy and Safety of AZD6244 in Combination With Docetaxel in Patients Receiving Second Line Non Small Cell Lung Cancer Treatment.

A Phase 2 study of Locally Advanced or Metastatic Non Small Cell Lung Cancer Stage IIIb - IV, sponsored by AstraZeneca.

Completed
Registry status
Phase 2
Development phase
212
Enrollment target
20
Study locations

NCT01750281: Completed Phase 2 study of Locally Advanced or Metastatic Non Small Cell Lung Cancer Stage IIIb - IV, sponsored by AstraZeneca.

NCT01750281 is a Phase 2 study of Locally Advanced or Metastatic Non Small Cell Lung Cancer Stage IIIb - IV that has completed, run by AstraZeneca. The registered enrollment target is 212 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (59% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01750281, a Phase 2 study of Locally Advanced or Metastatic Non Small Cell Lung Cancer Stage IIIb - IV, has completed, sponsored by AstraZeneca.

COMPLETED
Registry status
Phase 2
Development phase
212 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to treat patients with locally advanced or metastatic NSCLC with a combination therapy of selumetinib and two different doses of docetaxel 75mg/m2 or 60 mg/m2 vs placebo and compare how well each dose affects how their cancer responds. It will also help us to understand the tolerability profile of the different dosing regimens in these patients

Primary Outcome

Median time from randomisation until the date of objective disease progression or death (by any cause in the absence of progression). Progression is defined using Response Evaluation Criteria in Solid Tumours (RECIST v1.1): \>= 20% increase in the sum of diameters of Target Lesions (TL) and an absolute increase in sum of diameters of \>=5mm (compared to the previous minimum sum) or progression of Non TLs or a new lesion.

Conditions Studied

Locally Advanced or Metastatic Non Small Cell Lung Cancer Stage IIIb - IV

Interventions

  • DRUG Placebo
  • DRUG Docetaxel 75 mg/m2
  • DRUG Docetaxel 60 mg/m2
  • DRUG Selumetinib 75 mg

Study Locations (20)

Other

  • Research Site - Barretos
  • Research Site - Brasília
  • Research Site - Ijuí
  • Research Site - Porto Alegre
  • Research Site - Porto Alegre
  • Research Site - Porto Alegre
  • Research Site - Santo André

New York

  • Research Site - Mineola
  • Research Site - New York
  • Research Site - New York

Pennsylvania

  • Research Site - Hershey
  • Research Site - Philadelphia

California

  • Research Site - Santa Monica

Colorado

  • Research Site - Aurora

Florida

  • Research Site - Hollywood

Georgia

  • Research Site - Atlanta

Illinois

  • Research Site - Chicago

Trial Details

FieldValue
Enrollment Target 212 participants
Start Date 2012-12-18
Est. Completion 2022-10-31
Phase Phase 2
AstraZeneca

1,285 total trials

What the finished NCT01750281 record still lists

NCT01750281 is an interventional study that assigns participants to a tested intervention. The registered 212 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (59% higher).

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.

NCT01750281 names 20 study sites across 11 states, led by Other, New York, Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT01750281 about?

NCT01750281 is a clinical study titled "Assess Efficacy and Safety of AZD6244 in Combination With Docetaxel in Patients Receiving Second Line Non Small Cell Lung Cancer Treatment.". The purpose of this study is to treat patients with locally advanced or metastatic NSCLC with a combination therapy of selumetinib and two different doses of docetaxel 75mg/m2 or 60 mg/m2 vs placebo and compare how well each dose affects how their cancer responds. It will also help us to understand ...

What is the current status of trial NCT01750281?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 212 participants. The study started on 2012-12-18. Estimated completion is 2022-10-31.

What conditions does trial NCT01750281 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 NCT01750281?

The interventions under investigation include: Placebo (DRUG), Docetaxel 75 mg/m2 (DRUG), Docetaxel 60 mg/m2 (DRUG), Selumetinib 75 mg (DRUG).

Who is sponsoring clinical trial NCT01750281?

This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01750281 being conducted?

This trial has 20 study locations across California, Colorado, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Locally Advanced or Metastatic Non Small Cell Lung Cancer Stage IIIb - IV

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Where NCT01750281's enrollment target sits among peer trials

212 290th of 2000 higher than 1,711 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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Related registry views

Source: ClinicalTrials.gov NCT01750281, the US trial registry maintained by the National Library of Medicine. NCT01750281 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.