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A Phase 1b Clinical Trial of LDE225 in Combination With Fluorouracil, Leucovorin, Oxaliplatin and Irinotecan (FOLFIRINOX) in Previously Untreated Locally Advanced or Metastatic Pancreatic Adenocarcinoma, With an Expansion Cohort at the Recommended Phase 2 Dose


Phase 1
18 Years
72 Years
Open (Enrolling)
Both
Pancreatic Cancer

Thank you

Trial Information

A Phase 1b Clinical Trial of LDE225 in Combination With Fluorouracil, Leucovorin, Oxaliplatin and Irinotecan (FOLFIRINOX) in Previously Untreated Locally Advanced or Metastatic Pancreatic Adenocarcinoma, With an Expansion Cohort at the Recommended Phase 2 Dose


Study medication will be given in cycles of 14 days. Subjects will keep a study drug diary
for each treatment cycle. LDE225 capsules will be taken by mouth in the morning every day
of each cycle.

On days 1-2 of each cycle, subjects will take LDE225 at the clinic followed by FOLFIRINOX
intravenous infusion (through a vein).

Subjects will come to the clinic weekly for the first 5 weeks, then every other week (Week
7, 9, 11, etc.) and receive the following procedures:

Review of current medications and any side effects Physical exam Performance Status Blood
tests (2 teaspoons of blood) Assessment of tumor (repeated every 8 weeks) ECG at week 3 and
5

Subjects will also have pharmacokinetic (PK) blood samples taken. PK samples are used to
find out the amount of study medication in the blood. Each PK sample is about 1/2 teaspoon
of blood. Subjects will have PK samples taken on:

Day 1 of Cycles 1, 2, 3, 4, 6, and 7 before the dose of LDE225 Day 1 of Cycle 5 - drawn
before the first dose of LDE225 and at 1, 2, 3, 4, 5, and 6 hours Day 2 of Cycle 5: One PK
blood sample


Inclusion Criteria:



- Histologically or cytologically confirmed locally advanced or metastatic pancreatic
adenocarcinoma

- Previously untreated locally advanced or metastatic pancreatic adenocarcinoma. Pts
newly diagnosed with metastatic recurrence after adjuvant therapy for resected
disease are eligible, if completion of adjuvant therapy was > 8 months ago

- Measurable disease

- Adequate organ and marrow function

- Able to take oral drugs

Exclusion Criteria:

- Concurrent active primary or metastatic cancer other than superficial squamous cell
or basal cell skin cancer

- Pregnant or breastfeeding

- Receiving any other standard or investigation anticancer agents, with the exception
of hormonal therapy

- Prior chemoradiation to the primary pancreatic tumor unless there is a measurable
distant site of disease

- Known CNS metastases

- History of hypersensitivity reactions to any components of the treatment regimen

- Known malabsorption syndromes

- Neuromuscular disorders

- Receiving other anti-neoplastic therapy concurrently

- Requires warfarin/Coumadin for therapeutic coagulation

- Receiving treatment with medications known to be moderate and strong inhibitors or
inducers of CYP3A4/5

- Uncontrolled diarrhea

- Peripheral neuropathy > grade 1 due to any cause

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia other than chronic atrial fibrillation, or psychiatric illness/social
situations that would limit compliance with study requirements

- HIV positive

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Maximum Tolerated Dose

Outcome Description:

To determine the maximal tolerated doses of LDE225 in combination with FOLFIRINOX in patients with locally advanced or metastatic pancreatic adenocarcinoma

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

Eunice Kwak, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital

Authority:

United States: Food and Drug Administration

Study ID:

11-164

NCT ID:

NCT01485744

Start Date:

December 2011

Completion Date:

Related Keywords:

  • Pancreatic Cancer
  • metastatic
  • untreated
  • advanced
  • Pancreatic Neoplasms

Name

Location

Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Massachusetts General HospitalBoston, Massachusetts  02114-2617