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A Phase Ib, Open-label, Multicenter, Dose-escalation, Safety and Tolerability Study of LDE225 in Combination With Gemcitabine in Patients With Locally Advanced or Metastatic Pancreatic Adenocarcinoma


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Pancreatic Cancer

Thank you

Trial Information

A Phase Ib, Open-label, Multicenter, Dose-escalation, Safety and Tolerability Study of LDE225 in Combination With Gemcitabine in Patients With Locally Advanced or Metastatic Pancreatic Adenocarcinoma


Inclusion Criteria:



- Patients with locally advanced or metastatic pancreatic adenocarcinoma that have not
been previously treated or have progressed despite chemotherapy

- Performance status of 0 or 1 per WHO classification

- Adequate hematologic , renal and liver function

- Adequate blood creatine kinase value (CK < 1.5ULN)

Exclusion Criteria:

- Treatment with prior radiotherapy

- Pancreatic cancer that is potentially curable by surgery

- Women of childbearing potential unless they are using highly effective method of
contraception Other protocol-defined inclusion/exclusion criteria may apply

Other protocol-defined inclusion/exclusion criteria may apply.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence rate and category of dose limiting toxicities (DLTs)

Outcome Description:

Dose limiting toxicities that occur during the first 8 weeks (56 days) of treatment with LDE225+gemcitabine. Dose limiting toxicity is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, intercurrent illness, or concomitant medications that meets study specific criteria.

Outcome Time Frame:

first 8 weeks of study treatment

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CLDE225X2103

NCT ID:

NCT01487785

Start Date:

March 2012

Completion Date:

November 2013

Related Keywords:

  • Pancreatic Cancer
  • metastatic pancreatic cancer
  • LDE225
  • gemcitabine
  • locally advanced
  • adenocarcinoma
  • Adenocarcinoma
  • Pancreatic Neoplasms

Name

Location
Massachusetts General Hospital Dept. of Mass General Hospital Boston, Massachusetts  02114
Memorial Sloan Kettering Cancer Center MSKCC - SC New York, New York  10021
University of Utah / Huntsman Cancer Institute Huntsman UT Salt Lake City, Utah  84103