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NCT01641575 · ClinicalTrials.gov registry record · Phase 1

A Dose Ascending Study of Gemcitabine Elaidate (CO-101) in Combination With Cisplatin

A Phase 1 study, sponsored by Clovis Oncology.

Terminated
Registry status
Phase 1
Development phase
8
Enrollment target

NCT01641575: Clinical Trial Phase 1 study, sponsored by Clovis Oncology.

NCT01641575 is a Phase 1 study that was terminated before completion, run by Clovis Oncology. The registered enrollment target is 8 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01641575, a Phase 1 study, was terminated before completion, sponsored by Clovis Oncology.

TERMINATED
Registry status
Phase 1
Development phase
8 participants
Enrollment target

Study Summary

The purpose of the first part of the study is to evaluate the safety, tolerability, and pharmacokinetics of ascending doses of gemcitabine elaidate in combination with cisplatin given to patients with advanced solid tumors, and to select a dose for further evaluation in the second part of the study. The purpose of the second part of the study is to determine the safety, tolerability, and exploratory clinical activity of gemcitabine elaidate in combination with cisplatin given to patients with Stage IIIb/IV non-small-cell lung cancer (NSCLC).

Interventions

  • DRUG CO-1.01 and Cisplatin

Trial Details

FieldValue
Enrollment Target 8 participants
Start Date 2012-07
Est. Completion 2013-06
Phase Phase 1
Clovis Oncology

11 total trials

Why NCT01641575 stopped before completion

NCT01641575 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower).

The record links to 0 conditions, and to 1 intervention - of which CO-1.01 and Cisplatin is the first listed.

NCT01641575 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01641575 about?

NCT01641575 is a clinical study titled "A Dose Ascending Study of Gemcitabine Elaidate (CO-101) in Combination With Cisplatin". The purpose of the first part of the study is to evaluate the safety, tolerability, and pharmacokinetics of ascending doses of gemcitabine elaidate in combination with cisplatin given to patients with advanced solid tumors, and to select a dose for further evaluation in the second part of the study....

What is the current status of trial NCT01641575?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2012-07. Estimated completion is 2013-06.

What interventions are being tested in trial NCT01641575?

The interventions under investigation include: CO-1.01 and Cisplatin (DRUG).

Who is sponsoring clinical trial NCT01641575?

This trial is sponsored by Clovis Oncology, which has 11 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01641575's enrollment target sits among peer trials

8 1959th of 2000 higher than 29 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 NCT01641575, the US trial registry maintained by the National Library of Medicine. NCT01641575 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.