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NCT01068483 · ClinicalTrials.gov registry record · Phase 1

Safety of BKM120 Monotherapy in Advanced Solid Tumor Patients

A Phase 1 study of Breast Cancer and Ovarian Cancer, sponsored by Novartis Pharmaceuticals.

Completed
Registry status
Phase 1
Development phase
107
Enrollment target
5
Study locations

NCT01068483 is a Phase 1 study of Breast Cancer and Ovarian Cancer that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 107 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (96% lower). The trial reports 5 study locations across 4 states.

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The verdict

NCT01068483, a Phase 1 study of Breast Cancer and Ovarian Cancer, has completed, sponsored by Novartis Pharmaceuticals.

COMPLETED
Registry status
Phase 1
Development phase
107 participants
Enrollment target
5
Study locations

Study Summary

This is a first-in-man, phase I clinical research study with BKM120, a potent and highly specific oral pan-class I phosphatidylinositol-3-kinase (PI3K) inhibitor. The study consists of a dose escalation part followed by a MTD expansion part. Once the MTD has been defined, the MTD expansion part will be opened for enrollment.

Conditions Studied

Breast Cancer Ovarian Cancer Colon Cancer Endometrium Cancer

Interventions

  • DRUG BKM120

Study Locations (5)

Other

  • Novartis Investigative Site - Rotterdam
  • Novartis Investigative Site - Rotterdam

Tennessee

  • Sarah Cannon Research Institute Dept.ofSarahCannonCancerCtr(4) - Nashville

Ontario

  • Novartis Investigative Site - Toronto

Catalonia

  • Novartis Investigative Site - Barcelona

Trial Details

FieldValue
Enrollment Target 107 participants
Start Date 2008-11
Est. Completion 2012-08
Phase Phase 1

Sponsor

Novartis Pharmaceuticals

1,375 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01068483

The ClinicalTrials.gov registry entry for NCT01068483 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 107 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (96% lower). The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which BKM120 is the first listed.

NCT01068483 reports 5 study locations spanning 4 distinct geographic areas - top geographies include Other, Tennessee, Ontario.

Frequently Asked Questions

What is clinical trial NCT01068483 about?

NCT01068483 is a clinical study titled "Safety of BKM120 Monotherapy in Advanced Solid Tumor Patients". This is a first-in-man, phase I clinical research study with BKM120, a potent and highly specific oral pan-class I phosphatidylinositol-3-kinase (PI3K) inhibitor. The study consists of a dose escalation part followed by a MTD expansion part. Once the MTD has been defined, the MTD expansion part wil...

What is the current status of trial NCT01068483?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 107 participants. The study started on 2008-11. Estimated completion is 2012-08.

What conditions does trial NCT01068483 study?

This clinical trial studies the following conditions: Breast Cancer, Ovarian Cancer, Colon Cancer, Endometrium Cancer.

What interventions are being tested in trial NCT01068483?

The interventions under investigation include: BKM120 (DRUG).

Who is sponsoring clinical trial NCT01068483?

This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01068483 being conducted?

This trial has 5 study locations across Tennessee, Ontario, Catalonia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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

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.