We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been withdrawn prior to enrollment.
(No accrual)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01911416
First Posted: July 30, 2013
Last Update Posted: June 9, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Utah
  Purpose

Pancreatic cancer is considered a rare form of cancer with about 277,000 new cases diagnosed in 2008 world-wide, which is about 2.5% of all forms of cancer. However, pancreatic cancer is more common in developed countries where the rate of this tumor is on the rise compared to other types of cancer.

LDE225 is a new medicine that blocks a cellular pathway (called Hedgehog pathway) that is thought to be changed in some patients with pancreatic cancer. LDE225 is a medicine which has not been approved by the FDA for the treatment of people with your medical condition. The medicine being tested in this study is currently not "on the market" (available to buy) in any country.

The purpose of this study is to see the effect LDE225 has on blood and tumors.


Condition Intervention
Pancreatic Ductal Adenocarcinoma Drug: LDE225

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Biomarker Study to Identify Predictive Signatures of Response to LDE225 (Hedgehog Inhibitor) In Patients With Resectable Pancreatic Cancer

Resource links provided by NLM:


Further study details as provided by University of Utah:

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


Enrollment: 0
Study Start Date: January 2014
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: All participants
All participants on study
Drug: LDE225

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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:

    • Diaphragm, condom (by the partner), intrauterine device (copper or hormonal), sponge or spermicide. Hormonal contraceptives include any marketed contraceptive agent that includes an estrogen and/or a progestational agent.

  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01911416


Locations
United States, Utah
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: Ignacio Garrido-Laguna, MD Huntsman Cancer Institute
  More Information

Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT01911416     History of Changes
Other Study ID Numbers: HCI67198
First Submitted: July 11, 2013
First Posted: July 30, 2013
Last Update Posted: June 9, 2016
Last Verified: June 2016

Additional relevant MeSH terms:
Adenocarcinoma
Pancreatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases