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COMPLETED Phase 1

Phase Ib, Dose Escalation Study of Oral LDE225 in Combination With BKM120 in Patients With Advanced Solid Tumors

NCT01576666 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this study is to determine the maximum dose of LDE225 and BKM120 that can be safely given together to patients and/or the dose that will be used in future studies. This study will also learn more about how the combination of these two investigational drugs may work for patients with certain cancers (specifically metastatic breast cancer, advanced pancreatic adenocarcinoma, metastatic colorectal cancer and recurrent glioblastoma multiforme).

Interventions

  • DRUG LDE225
  • DRUG BKM120

Study Locations (20)

Texas

  • Texas Oncology Midtown Texas Oncology — Dallas
  • Sammons Cancer Center - Texas Oncology SC-2 — Dallas
  • University of Texas/MD Anderson Cancer Center SC-3 — Houston

California

  • Cedars Sinai Medical Center SC — Los Angeles
  • University of California San Francisco UCSF (SC) — San Francisco

Oregon

  • Willamette Valley Clinical Studies Williamette Valley Cancer — Eugene
  • Northwest Cancer Specialists Northwest Cancer — Portland

Other

  • Novartis Investigative Site — Wilrijk
  • Novartis Investigative Site — Essen

Florida

  • H. Lee Moffitt Cancer Center & Research Institute Moffitt 4 — Tampa

Massachusetts

  • Dana Farber Cancer Institute Dana SC — Boston

Minnesota

  • Mayo Clinic - Rochester Division of Hematology — Rochester

North Carolina

  • Duke University Medical Center Duke - Baker — Durham

Trial Details

FieldValue
Enrollment Target 120 participants
Start Date 2012-07
Est. Completion 2015-04
Phase Phase 1

Sponsor

Novartis Pharmaceuticals

792 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01576666

The ClinicalTrials.gov registry entry for NCT01576666 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 792 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 10 conditions, with Gastric Cancer appearing as the primary indexed condition, and to 2 interventions — of which LDE225 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01576666 reports 20 study locations spanning 15 distinct geographic areas — top geographies include Texas, California, Oregon. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT01576666 about?

NCT01576666 is a clinical study titled "Phase Ib, Dose Escalation Study of Oral LDE225 in Combination With BKM120 in Patients With Advanced Solid Tumors". The purpose of this study is to determine the maximum dose of LDE225 and BKM120 that can be safely given together to patients and/or the dose that will be used in future studies. This study will also learn more about how the combination of these two investigational drugs may work for patients with c...

What is the current status of trial NCT01576666?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 120 participants. The study started on 2012-07. Estimated completion is 2015-04.

What conditions does trial NCT01576666 study?

This clinical trial studies the following conditions: Gastric Cancer, Advanced Solid Tumors, Metastatic Breast Cancer, Metastatic Colorectal Cancer, Safety. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01576666?

The interventions under investigation include: LDE225 (DRUG), BKM120 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01576666?

This trial is sponsored by Novartis Pharmaceuticals, which has 792 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01576666 being conducted?

This trial has 20 study locations across California, Florida, Massachusetts, Minnesota, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

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