A Clinical Trial of Anti-Angiogenic Drug Combination Tl-118 for Pancreatic Cancer Patients Who Are Starting Gemcitabine Treatment
1 other identifier
interventional
99
2 countries
10
Brief Summary
TL-118 is an anti-angiogenic drug combination designed for the treatment of cancer. The investigational product Tl-118 comprises of four well-known active components. The therapy is administrated at a unique dosing regimen that was found to be effective and advantageous in terms of safety. The product is formulated as an oral suspension, conveniently administrated by the patients at home and not requiring medical staff assistance. This Phase II clinical trial aims to evaluate the efficacy, safety and tolerability of TL-118 in Gemcitabine treated Pancreatic Cancer patients
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2012
Longer than P75 for phase_2
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
January 5, 2012
CompletedFirst Posted
Study publicly available on registry
January 13, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2017
CompletedFebruary 5, 2016
February 1, 2016
4.8 years
January 5, 2012
February 4, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Disease Control Rate as defined by Percentage of patients experiencing a Complete Response or a Partial Response or a Stable Disease according to RECIST measured at 16 weeks after treatment initiation
16 weeks after treatment initiation
Secondary Outcomes (4)
Response Rate
Measured at week 16
Quality of life
Baseline to study completion
Progression free survival
Measured at week 16 and 52
Overall Survival
Measured at week 16 and 52
Study Arms (2)
TL-118 with standard of care Gemcitabine
EXPERIMENTALGemcitabine with out TL-118
ACTIVE COMPARATORInterventions
TL-118 investigational product is supplied as an oral liquid for daily administration at a specific dosing regimen. Treatment protocol includes weekly therapy cycles.
Monthly cycles of 3 weekly treatments a month and one week off of treatment
Eligibility Criteria
You may qualify if:
- Age at least 18 years at enrollment.
- Metastatic Pancreatic Cancer
- The patient has histologically or cytologically confirmed pancreatic adenocarcinoma.
- Patient has measurable disease by (RECIST).
- Patient is starting standard of care Gemcitabine treatment
- ECOG performance status ≤ 1
- 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. -
You may not qualify if:
- Hypersensitivity to one or more of the TL-118 active components
- Known Glucose-6-phosphate-dehydrogenase deficiency (G6PD).
- CNS or Brain metastases
- Prior systemic therapy for pancreas cancer
- Subjects who received any investigational medication, prior local therapy for pancreas cancer , or any significant change in treatment within 1 month prior to screening
- Concurrent use of any other investigational product
- Subjects with a clinically significant or unstable medical condition that would preclude safe and complete study participation
- Use of supplements or complementary medicines/botanicals, except for conventional multivitamin supplements, calcium, selenium and soy supplements.
- Patient has known historical or active infection with HIV, hepatitis B, or hepatitis C
- Circumstances likely to interfere with absorption of orally administrated drugs.
- History of noncompliance to medical regimens or coexisting -
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tiltan Pharma Ltd.lead
- Technostatcollaborator
- Novatrialscollaborator
Study Sites (10)
Emory Clinic
Atlanta, Georgia, 30322, United States
White Plains Hospital
White Plains, New York, 10601, United States
Assaf Harofe Medical Center
Ẕerifin, Zerifin, 70300, Israel
HaEmek Medical Center
Afula, Israel
Soroka Medical Center
Beersheba, Israel
Hillel Yaffe Medical Center
Hadera, 38100, Israel
Rambam Medical Center
Haifa, Israel
Hadassah Medical Center
Jerusalem, Israel
Sheba Medical Center
Ramat Gan, Israel
Sourasky Medical Center
Tel Aviv, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 5, 2012
First Posted
January 13, 2012
Study Start
January 1, 2012
Primary Completion
October 1, 2016
Study Completion
January 1, 2017
Last Updated
February 5, 2016
Record last verified: 2016-02