A Biomarker Study To Identify Predictive Signatures Of Response To LDE225 (Hedgehog Inhibitor) In Patients With Resectable Pancreatic Cancer

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2013-07-11	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2016-06-07
First Submitted that Met QC Criteria 2013-07-25	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2016-06-09
First Posted (ESTIMATED) 2013-07-30	Results First Posted N/A	Last Verified 2016-06

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: All participants All participants on study	DRUG: LDE225

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: All participants

All participants on study

DRUG: LDE225

Primary Outcome Measures	Measure Description	Time Frame
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	Correlation between plasma and tumour concentrations of LDE225	36 months

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Age 18 years or older
Histologically documented diagnosis of pancreatic ductal adenocarcinoma
Patients with resectable pancreatic ductal adenocarcinoma or borderline resectable disease that after neoadjuvant treatment are considered appropriate candidates for resection
ECOG or Performance Status of 0-2
Patients with adequate bone marrow, liver and renal function, as specified below:

Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L
Hemoglobin (Hgb) ≥ 9 g/dL
Platelets ≥ 80 x 109/L
Serum total bilirubin ≤ 1.5 x ULN(upper limit of normal)
AST and ALT ≤ 2.5 x ULN or ≤ 5 x ULN if liver metastases are present
Plasma creatine phosphokinase (CK) < 1.5 x ULN
Serum creatinine ≤ 1.5 x ULN or 24-hour clearance ≥ 50ml/min
Written informed consent obtained prior to any study specific screening procedures

Patients who have had major surgery within 4 weeks of initiation of study medication.
Patients with concurrent uncontrolled medical conditions that may interfere with their participation in the study or potentially affect the interpretation of the study data.
Patients unable to take oral drugs or with lack of physical integrity of the upper gastrointestinal tract or known malabsorption syndromes.
Patients who have previously been treated with systemic LDE225 or with other Hh pathway inhibitors.
a) Patients who have neuromuscular disorders (e.g. inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis and spinal muscular atrophy) or are on concomitant treatment with drugs that are recognized to cause rhabdomyolysis, such as HMG CoA inhibitors (statins), clofibrate and gemfibrozil, and that cannot be discontinued at least 2 weeks prior to starting LDE225 treatment. If it is essential that the patient stays on a statin to control hyperlididemia, only pravastatin may be used with extra caution. b) Patients who are planning on embarking on a new strenuous exercise regimen after initiation of study treatment. NB: Muscular activities, such as strenuous exercise, that can result in significant increases in plasma CK levels should be avoided whilst on LDE225 treatment.
Patients who have taken part in an experimental drug study within 4 weeks of initiating treatment with LDE225.
Patients who are receiving other anti-neoplastic therapy (e.g. chemotherapy, targeted therapy or radiotherapy) concurrently or within 2 weeks of starting treatment with LDE225.
Patients who are receiving treatment with medications known to be moderate and strong inhibitors or inducers of CYP3A4/5 or drugs metabolized by CYP2B6 or CYP2C9 that have narrow therapeutic index, and that cannot be discontinued before starting treatment with LDE225. Medications that are strong CYP3A4/5 inhibitors should be discontinued at least 7 days and strong CYP3A/5 inducers for at least 2 weeks prior to starting treatment with LDE225.
Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/mL).
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they are using two birth control methods. The two methods can be a double barrier method or a barrier method plus a hormonal method. Adequate barrier methods of contraception include:

Reliable contraception should be maintained throughout the study and for 3 months after study drug discontinuation.
Patients unwilling or unable to comply with the protocol.
Patients who are not candidates to undergo laparoscopic examination and biopsy

Collaborators and Investigators

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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Resources

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Caregivers

Clinical Trial Record