- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01659502
Investigator's Initiated Phase II Study for Pancreatic Cancer Patients
December 4, 2013 updated by: Tzivia Berkman, Tiltan Pharma Ltd.
The purpose of this study is to evaluate the efficacy, safety and tolerability of TL-118 alone or in combination with pancreatic cancer chemotherapy.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
10
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ayala Huberrt, MD
- Email: AyalaH@hadassah.org.il
Study Locations
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Jerusalem, Israel
- Hadassah Medical Center
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Contact:
- Ayala Hubert, MD
- Email: ayalah@hadassah.org.il
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Principal Investigator:
- Ayala Hubert, MD
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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.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age at least 18 years at enrollment.
- Locally Advanced Pancreatic Cancer and/or Metastatic Pancreatic Cancer which failed to respond to one or two lines of chemotherapy
- The patient has histologically or cytologically confirmed pancreatic cancer.
- Patient has measurable disease by radiological imaging techniques as defined according to Response Evaluation Criteria in Solid Tumors (RECIST).
- ECOG performance status ≤ 2
- Adequate renal function.
- Adequate hepatic function
- Adequate bone marrow reserve -
- Resolution of prior therapy acute adverse events.
- Patient is capable of swallowing.
- Patient's Informed Consent.
Exclusion Criteria:
- Hypersensitivity to one or more of the TL-118 active components
- Known Glucose-6-phosphate-dehydrogenase deficiency (G6PD).
- Known CNS or Brain metastases
- Patient has received 3 or more different prior chemotherapies for the treatment of pancreatic cancer
- Any significant change in treatment within the 14 days before screening or an un-stable medical condition that may affect patient participation or evaluation in the study.
- Concurrent use of any other investigational product or within 28 days before study entry.
- Chronic treatment with: (a) immunosuppressive agent other than systemic corticosteroid, (b) patients who are under chronic treatment with NSAIDs with the exception of Aspirin at a daily dose ≤ 100mg.
- Use of supplements or complementary medicines/botanicals, except for conventional multivitamin supplements, calcium, selenium and soy supplements.
- Patients at increased risk of gastro intestinal bleeding such as patients with known active gastro intestinal ulcer, erosive gastritis or varices, as confirmed by gastroscopy performed within one year before screening.
- Serious or uncontrolled co-existent diseases that are likely to significantly increase the risks associated with TL-118 therapy (e.g. severe cardiovascular disease, congestive heart failure, recent myocardial infarction, significant vascular disease, active or uncontrolled autoimmune disease, active or uncontrolled infection).
- Patient has known historical or active infection with HIV, hepatitis B, or hepatitis C
- Serious or non-healing wound, ulcer or bone fracture.
- Circumstances likely to interfere with absorption of orally administrated drugs.
- History of noncompliance to medical regimens or coexisting conditions precluding full compliance with study protocol, or any other condition that in the discretion of the Investigator may preclude safe and complete study participation.
- Subjects unwilling or unable to comply with study protocol.
- Know pregnancy or breast-feeding women.
- Women of child bearing potential not exercising two methods of contraception.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: TL-118 alone or with pancreas cancer chemotherapy
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TL-118 investigational product is supplied as an oral liquid for daily administration at a specific dosing regimen.
Treatment protocol includes weekly therapy cycles
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical Benefit Measurement
Time Frame: Baseline up to 2 years
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Clinical Benefit Measurement is a composite of measurements of pain (analgesic consumption and pain intensity), performance status and weight.
Clinical benefit requires an improvement in at least one parameter, without worsening in any others, sustained for at least 4 weeks
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Baseline up to 2 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety and tolerability
Time Frame: Baseline up to 2 years
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Safety and tolerability profiles will be judged by:
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Baseline up to 2 years
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Response Rate (RR)
Time Frame: RR measured every 8 weeks after enrollment up to 2 years
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RR measured every 8 weeks after enrollment up to 2 years
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Overall Survival
Time Frame: OS measured at 16 and 52 weeks after treatment initiation or at death, whichever comes first up to 2 years
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OS measured at 16 and 52 weeks after treatment initiation or at death, whichever comes first up to 2 years
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Progression Free Survival (PFS)
Time Frame: PFS measured at 8 weeks after enrollment until the date of first documented progression or date of death, whichever comes first, up to 2 years
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PFS measured at 8 weeks after enrollment until the date of first documented progression or date of death, whichever comes first, up to 2 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
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 Major Dates
Study Start
December 1, 2013
Primary Completion (Anticipated)
October 1, 2014
Study Registration Dates
First Submitted
July 23, 2012
First Submitted That Met QC Criteria
August 6, 2012
First Posted (Estimate)
August 7, 2012
Study Record Updates
Last Update Posted (Estimate)
December 5, 2013
Last Update Submitted That Met QC Criteria
December 4, 2013
Last Verified
December 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TLH-207
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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