LDE225 With Fluorouracil, Leucovorin, Oxaliplatin, and Irinotecan for Untreated Advanced Pancreatic Cancer
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Cancer, Cancer, Pancreatic Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 72 |
| Updated: | 11/10/2018 |
| Start Date: | December 2011 |
| End Date: | March 2019 |
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
LDE225 is a new medicine that blocks the Hedgehog (Hh) pathway. The Hh pathway is a cascade
of molecular events that control cell growth and have been linked with the development of
many human cancers, including pancreatic cancer. Information from research studies suggests
that LDE225 in combination with FOLFIRINOX may help to stop the growth of cancer cells. In
this research study, the investigators are looking to determine the maximum dose of LDE225 in
combination that can be given safely to patients with locally advanced or metastatic
pancreatic cancer.
of molecular events that control cell growth and have been linked with the development of
many human cancers, including pancreatic cancer. Information from research studies suggests
that LDE225 in combination with FOLFIRINOX may help to stop the growth of cancer cells. In
this research study, the investigators are looking to determine the maximum dose of LDE225 in
combination that can be given safely to patients with locally advanced or metastatic
pancreatic cancer.
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
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
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