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Resectable Pancreatic CancerEarly Phase 1NCT01694589

A Pilot Study of a Hedgehog Pathway Inhibitor (LDE-225) in Surgically Resectable Pancreas Cancer

A Early Phase 1 study testing LDE-225 in people with Resectable Pancreatic Cancer, run by Rutgers, The State University of New Jersey at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

We hypothesize that administration of LDE-225 in humans with pancreatic cancer will result in inhibition of paracrine HH signaling in the pancreatic tumor stroma while having no effect on autocrine signaling in the tumor cell compartment. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Resectable Pancreatic Cancer
What is being tested?
LDE-225
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
Nov 2012to Jul 2014
Phase
Early Phase 1
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

  • Patients with biopsy probable, resectable pancreatic cancer. Patients will be expected to undergo surgery a minimum of 14 days following signing consent.
  • Patients must give informed consent.
  • Patients must be over 18 and have an ECOG performance status ≤2 and life expectancy > 3 months.
  • Patients must have normal organ and marrow function as defined below:
  • ANC ≥1,500 /µL
  • Platelets ≥100,000 /µL
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  • Hemoglobin>10gm/dl
  • creatinine <1.5 X ULN
  • Plasma creatine phosphokinase (CK) < 1.5 x ULN
  • PT/PTT WNL
  • Patients may have abnormal bilirubin, which is concluded by the surgeon to be related to biliary ductal obstruction, may be included if bilirubin < 3 X ULN.
  • Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) < 2.5 x upper limit of normal (ULN).

Who cannot join

  • Poor surgical risk due to comorbidities or poor performance status
  • Patients who have received prior treatment with a smoothened antagonist, (GDC-0449 (Genentech), IPI-926 (Infinity).
  • Patients who have received chemotherapy within a period of time that is < the cycle length used for that treatment (e.g. <6 weeks for nitrosoureas, mitomycin-C) prior to starting study drug or who have not recovered from the side effects of such therapy
  • Patients who have received wide field radiotherapy (including therapeutic radioisotopes such as strontium 89) ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy.
  • Patients who have received biologic therapy (e.g. antibodies) ≤ 4 weeks prior to starting study drug or who have not recovered from the side effects of such therapy
  • Patients who have been treated with a targeted agent ≤ 5 t1/2 or ≤ 4 weeks (whichever is shorter) prior to starting study drug or who have not recovered from the side effects of such therapy
Show all 31Show fewer
  • Patients who have received any other investigational agents ≤ 5 t1/2 or ≤ 4 weeks (whichever is shorter) prior to starting study drug or who have not recovered from the side effects of such therapy
  • Poor oral intake and/or inability to take capsules
  • Impairment of gastrointestinal function or gastrointestinal disease such as Chron's Disease or Ulcerative Cholitis, short-gut syndrome, celiac sprue disease that may significantly alter the absorption of LDE225
  • Urgent/emergent need for surgery (< 7 days)
  • Documented cirrhotic liver disease, ongoing alcohol abuse, or known active or acute hepatitis
  • Impaired cardiac function or clinically significant heart disease, including any one of the following:
  • Angina pectoris within 3 months
  • Acute myocardial infarction within 3 months
  • QTcF > 450 msec for males and > 470 msec for females on the screening ECG
  • A past medical history of clinically significant ECG abnormalities or a family history of prolonged QT-interval syndrome
  • Other clinically significant heart disease (e.g. congestive heart failure, uncontrolled hypertension, history of labile hypertension, or history of poor compliance with an antihypertensive regimen)
  • Patients who have had a venous thromboembolic event (e.g., pulmonary embolism or deep vein thrombosis) requiring anticoagulation
  • Presence of active infection or systemic use of antibiotics within 72 hours of enrollment.
  • Significant co-morbid condition or disease which in the judgment of the Investigator would place the patient at undue risk or interfere with the study. Examples include, but are not limited to sepsis, recent significant cardiac or pulmonary disease, or other conditions.
  • Known human immunodeficiency virus (HIV) positivity
  • Known hypersensitivity to LDE-225, or any of the excipients in LDE-225
  • Pregnant or lactating women.
  • 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.
  • 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 hyperlipidemia, only pravastatin may be used with extra caution.
  • 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.
  • Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 4 months after stopping study treatment.
  • Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential.
  • Sexually active males must use a condom during intercourse while taking the drug and for 6 months after stopping treatment and should not father a child in this period.
  • Patients unwilling or unable to comply with the protocol.
  • Step Two Adequate Fine Needle Biopsy

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08901

Other trials in United States

About this study

We hypothesize that administration of LDE-225 in humans with pancreatic cancer will result in inhibition of paracrine HH signaling in the pancreatic tumor stroma while having no effect on autocrine signaling in the tumor cell compartment. Furthermore we hypothesize that treatment with LDE-225 will result in changes in the tumor stroma (decreased desmoplasia, increased vascularity) that will result in improved tumor blood flow.

The purpose of this study is to determine if, where and how LDE-225 works in pancreatic cancer. A cancer cell's growth can depend on the cells and tissue around it. The cells and tissue make chemical signals to influence the cancer's growth. This research study is evaluating LDE-225 designed to interfere with one of the growth signals causing pancreatic cancer growth.

Being tested
LDE-225
Keywords
pancreatic cancer, resectable pancreatic cancer
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LDE-225Drug

    Also called NVP-LDE225, Erismodegib

    LDE-225 capsules will be administered as a fixed dose of 800 mg daily for two weeks.

Study groups in NCT01694589
Study groupRoleWhat they receive
LDE-225ExperimentalLDE-225: dose - 800 mg, taken by mouth once daily for 2 weeks.
Receives: Drug: LDE-225

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in mean Gli-1 levels before and after drug

    Means and variances of the (transformed) data for samples from stroma and tumor are calculated. Data is collected from patients in pairs (with the first observation from the biopsy prior to drug and the second after surgery, and after the drug), and it is expected these two observations will be correlated. Detectable differences for a range of four correlations will be computed.

    Measured: 2 years

Secondary outcomes (1)

  1. Complications from surgery by time of hospital discharge up to 30 days post-operatively

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Sep 2012 (estimated)
  2. Study startNov 2012
  3. Primary completionJun 2014
  4. Study completionJul 2014

Why it stopped: Lack of accrual

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01694589
Sponsor's protocol ID
071108
Other IDs
0220120066, P30CA072720
Status last verified
Dec 2014
First submitted
24 Sep 2012
Last updated
12 Dec 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing LDE-225 in people with Resectable Pancreatic Cancer, run by Rutgers, The State University of New Jersey 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 12 inclusion and 31 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 12 Dec 2014. 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.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Changes in mean Gli-1 levels before and after drug (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01694589.

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 12 Dec 2014.

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