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NCT01268059 · ClinicalTrials.gov registry record · Phase 1

A Study of Carboplatin and Paclitaxel With or Without MEDI-575 in Untreated, Advanced Non-Small Cell Lung Cancer

A Phase 1 study, sponsored by MedImmune.

Terminated
Registry status
Phase 1
Development phase
99
Enrollment target

NCT01268059: Clinical Trial Phase 1 study, sponsored by MedImmune.

NCT01268059 is a Phase 1 study that was terminated before completion, run by MedImmune. The registered enrollment target is 99 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01268059, a Phase 1 study, was terminated before completion, sponsored by MedImmune.

TERMINATED
Registry status
Phase 1
Development phase
99 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate the dose, antitumor activity, safety and pharmacology of MEDI-575 in combination with carboplatin/paclitaxel in subjects with previously untreated, advanced non-small cell lung cancer (NSCLC).

Primary Outcome

A DLT was defined as: 1. Any treatment-related Grade 3 or higher non-hematologic toxicity that occurred during the DLT assessment period with the following exceptions: 1. Grade 3 fever (in the absence of neutropenia) defined as more than (\>) 40.0 degree Celcius (\> 104.0 degree Fahrenheit) that resolved to normal or baseline within 24 hours of treatment and was not considered a serious adverse event (SAE); or 2. Grade 3 rigors/chills that responded to optimal therapy. 2. Any treatment-r

Interventions

  • DRUG Carboplatin
  • DRUG Paclitaxel
  • DRUG MEDI-575

Trial Details

FieldValue
Enrollment Target 99 participants
Start Date 2010-12-16
Est. Completion 2013-09-11
Phase Phase 1
MedImmune

210 total trials

Why NCT01268059 stopped before completion

NCT01268059 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 99 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% higher).

The record links to 0 conditions, and to 3 interventions - of which Carboplatin is the first listed.

NCT01268059 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01268059 about?

NCT01268059 is a clinical study titled "A Study of Carboplatin and Paclitaxel With or Without MEDI-575 in Untreated, Advanced Non-Small Cell Lung Cancer". The purpose of this study is to evaluate the dose, antitumor activity, safety and pharmacology of MEDI-575 in combination with carboplatin/paclitaxel in subjects with previously untreated, advanced non-small cell lung cancer (NSCLC).

What is the current status of trial NCT01268059?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 99 participants. The study started on 2010-12-16. Estimated completion is 2013-09-11.

What interventions are being tested in trial NCT01268059?

The interventions under investigation include: Carboplatin (DRUG), Paclitaxel (DRUG), MEDI-575 (DRUG).

Who is sponsoring clinical trial NCT01268059?

This trial is sponsored by MedImmune, which has 210 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01268059's enrollment target sits among peer trials

99 590th of 2000 higher than 1,409 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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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Source: ClinicalTrials.gov NCT01268059, the US trial registry maintained by the National Library of Medicine. NCT01268059 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.