Investigator's Initiated Phase II Study for Pancreatic Cancer Patients
NCT ID: NCT01659502
Last Updated: 2013-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE2
10 participants
INTERVENTIONAL
2013-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
TL-118 alone or with pancreas cancer chemotherapy
TL-118
TL-118 investigational product is supplied as an oral liquid for daily administration at a specific dosing regimen. Treatment protocol includes weekly therapy cycles
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
TL-118
TL-118 investigational product is supplied as an oral liquid for daily administration at a specific dosing regimen. Treatment protocol includes weekly therapy cycles
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Locally Advanced Pancreatic Cancer and/or Metastatic Pancreatic Cancer which failed to respond to one or two lines of chemotherapy
3. The patient has histologically or cytologically confirmed pancreatic cancer.
4. Patient has measurable disease by radiological imaging techniques as defined according to Response Evaluation Criteria in Solid Tumors (RECIST).
5. ECOG performance status ≤ 2
6. Adequate renal function.
7. Adequate hepatic function
8. Adequate bone marrow reserve -
9. Resolution of prior therapy acute adverse events.
10. Patient is capable of swallowing.
11. Patient's Informed Consent.
Exclusion Criteria
2. Known Glucose-6-phosphate-dehydrogenase deficiency (G6PD).
3. Known CNS or Brain metastases
4. Patient has received 3 or more different prior chemotherapies for the treatment of pancreatic cancer
5. 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.
6. Concurrent use of any other investigational product or within 28 days before study entry.
7. 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.
8. Use of supplements or complementary medicines/botanicals, except for conventional multivitamin supplements, calcium, selenium and soy supplements.
9. 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.
10. 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).
11. Patient has known historical or active infection with HIV, hepatitis B, or hepatitis C
12. Serious or non-healing wound, ulcer or bone fracture.
13. Circumstances likely to interfere with absorption of orally administrated drugs.
14. 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.
15. Subjects unwilling or unable to comply with study protocol.
16. Know pregnancy or breast-feeding women.
17. Women of child bearing potential not exercising two methods of contraception.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Tiltan Pharma Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Tzivia Berkman
Dr Ayala Hubert
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hadassah Medical Center
Jerusalem, , Israel
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Ayala Hubert, MD
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TLH-207
Identifier Type: -
Identifier Source: org_study_id