Pancreatic Ductal AdenocarcinomaNCT01911416
A Biomarker Study to Identify Predictive Signatures of Response to LDE225 (Hedgehog Inhibitor) In Patients With Resectable Pancreatic Cancer
A study testing LDE225 in people with Pancreatic Ductal Adenocarcinoma, run by University of Utah at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Ductal Adenocarcinoma
- What is being tested?
- LDE225
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Being tested
- LDE225
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LDE225Drug
| Study group | Role | What they receive |
|---|---|---|
| All participants | Experimental | All participants on study Receives: Drug: LDE225 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Correlation between plasma and tumour concentrations of LDE225
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2013 (estimated)
- Study startJan 2014
- Primary completionOct 2014
- Study completionOct 2014
Why it stopped: No accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Ductal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ignacio Garrido-Laguna, MD, Principal investigator, Huntsman Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01911416
- Sponsor's protocol ID
- HCI67198
- Status last verified
- Jun 2016
- First submitted
- 11 Jul 2013
- Last updated
- 9 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Biomarker Study to Identify Predictive Signatures of Response to LDE225 (Hedgehog Inhibitor) In Patients With Resectable Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT01911416
- Acronym / sponsor ID
- HCI67198
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 30 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All participants | Experimental | Drug: LDE225All participants on study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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:
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LDE225 | Drug | All participants |
Primary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ignacio Garrido-Laguna, MD principal investigator
Huntsman Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LDE225 in people with Pancreatic Ductal Adenocarcinoma, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Adverse Events as a Measure of Safety and Tolerability (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2016.