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NCT01347866 · ClinicalTrials.gov registry record · Phase 1

Clinical Study Of PI3K/mTOR Inhibitors In Combination With An Oral MEK Inhibitor Or Irinotecan In Patients With Advanced Cancer

A Phase 1 study, sponsored by Pfizer.

Terminated
Registry status
Phase 1
Development phase
105
Enrollment target

NCT01347866 is a Phase 1 study that was terminated before completion, run by Pfizer. The registered enrollment target is 105 participants.

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The verdict

NCT01347866, a Phase 1 study, was terminated before completion, sponsored by Pfizer.

TERMINATED
Registry status
Phase 1
Development phase
105 participants
Enrollment target

Study Summary

After the fourth protocol amendment two study arms are evaluated in this clinical protocol: PD-0325901 (oral MEK inhibitor) plus PF-05212384 (intravenous PI3K/mTOR inhibitor) and PF-05212384 plus irinotecan. The study will assess safety, pharmacokinetics and pharmacodynamics of these combinations in patients with advanced cancer. Once the maximum tolerated doses are identified, further assessment of these combinations will be done in patients with previously treated metastatic colorectal or pancreatic cancer for the PF-05212384 plus irinotecan arm and in patients with ovarian cancer or KRAS mutated non small cell lung cancer for the combination of PF-05212384 plus PD-0325901.

Interventions

  • DRUG irinotecan
  • DRUG PD-0325901
  • DRUG PF-05212384

Trial Details

FieldValue
Enrollment Target 105 participants
Start Date 2011-10
Est. Completion 2015-12
Phase Phase 1

Sponsor

Pfizer

1,845 total trials

What the Registry Record Tells You About NCT01347866

The ClinicalTrials.gov registry entry for NCT01347866 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 105 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.

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

NCT01347866 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01347866 about?

NCT01347866 is a clinical study titled "Clinical Study Of PI3K/mTOR Inhibitors In Combination With An Oral MEK Inhibitor Or Irinotecan In Patients With Advanced Cancer". After the fourth protocol amendment two study arms are evaluated in this clinical protocol: PD-0325901 (oral MEK inhibitor) plus PF-05212384 (intravenous PI3K/mTOR inhibitor) and PF-05212384 plus irinotecan. The study will assess safety, pharmacokinetics and pharmacodynamics of these combinations in...

What is the current status of trial NCT01347866?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 105 participants. The study started on 2011-10. Estimated completion is 2015-12.

What interventions are being tested in trial NCT01347866?

The interventions under investigation include: irinotecan (DRUG), PD-0325901 (DRUG), PF-05212384 (DRUG).

Who is sponsoring clinical trial NCT01347866?

This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.