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A Clinical Trial of Anti-Angiogenic Drug Combination Tl-118 for Pancreatic Cancer Patients Who Are Starting Gemcitabine Treatment
Conditions
Metastatic Pancreatic Cancer
Conditions: official terms
Pancreatic Neoplasms
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: TL-118
Type: Drug
Overall Status
Recruiting
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
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:
1. Age at least 18 years at enrollment.
2. Metastatic Pancreatic Cancer
3. The patient has histologically or cytologically confirmed pancreatic adenocarcinoma.
4. Patient has measurable disease by (RECIST).
5. Patient is starting standard of care Gemcitabine treatment
6. ECOG performance status ≤ 1
7. Adequate renal function
8. Adequate hepatic function
9. Adequate bone marrow reserve
10. Resolution of prior therapy acute adverse events.
11. Patient is capable of swallowing.
12. Patient's Informed Consent. -
Exclusion Criteria:
1. Hypersensitivity to one or more of the TL-118 active components
2. Known Glucose-6-phosphate-dehydrogenase deficiency (G6PD).
3. CNS or Brain metastases
4. Prior systemic therapy for pancreas cancer
5. Subjects who received any investigational medication, prior local therapy for pancreas cancer , or any significant change in treatment within 1 month prior to screening
6. Concurrent use of any other investigational product
7. Subjects with a clinically significant or unstable medical condition that would preclude safe and complete study participation
8. Use of supplements or complementary medicines/botanicals, except for conventional multivitamin supplements, calcium, selenium and soy supplements.
9. Patient has known historical or active infection with HIV, hepatitis B, or hepatitis C
10. Circumstances likely to interfere with absorption of orally administrated drugs.
11. History of noncompliance to medical regimens or coexisting -
1. Age at least 18 years at enrollment.
2. Metastatic Pancreatic Cancer
3. The patient has histologically or cytologically confirmed pancreatic adenocarcinoma.
4. Patient has measurable disease by (RECIST).
5. Patient is starting standard of care Gemcitabine treatment
6. ECOG performance status ≤ 1
7. Adequate renal function
8. Adequate hepatic function
9. Adequate bone marrow reserve
10. Resolution of prior therapy acute adverse events.
11. Patient is capable of swallowing.
12. Patient's Informed Consent. -
Exclusion Criteria:
1. Hypersensitivity to one or more of the TL-118 active components
2. Known Glucose-6-phosphate-dehydrogenase deficiency (G6PD).
3. CNS or Brain metastases
4. Prior systemic therapy for pancreas cancer
5. Subjects who received any investigational medication, prior local therapy for pancreas cancer , or any significant change in treatment within 1 month prior to screening
6. Concurrent use of any other investigational product
7. Subjects with a clinically significant or unstable medical condition that would preclude safe and complete study participation
8. Use of supplements or complementary medicines/botanicals, except for conventional multivitamin supplements, calcium, selenium and soy supplements.
9. Patient has known historical or active infection with HIV, hepatitis B, or hepatitis C
10. Circumstances likely to interfere with absorption of orally administrated drugs.
11. History of noncompliance to medical regimens or coexisting -
Locations
Emory Clinic
Atlanta, Georgia, United States
White Plains Hospital
Status: Not yet recruiting
Contact: Bassel El-Rayes, MD - Bassel.el-rayes@emoryhealthcare.org
White Plains, New York, United States
Soroka Medical Center
Status: Recruiting
Contact: Dan Costin, MD - dancostin@witcbd.net
Be'er Sheva, Israel
Hillel Yaffe Medical Center
Status: Recruiting
Contact: Sofia Man, MD - sman@bgu.ac.il
Hadera, Israel
Rambam Medical Center
Status: Not yet recruiting
Contact: Katerina Shulman, MD - KaterinaS@hy.health.gov.il
Haifa, Israel
Hadassah Medical Center
Status: Recruiting
Contact: Ron Epelbaum, MD - epelbaum@rambam.health.gov.il
Jerusalem, Israel
Sheba Medical Center
Status: Recruiting
Contact: Ayala Hubert, MD - AyalaH@hadassah.org.il
Ramat-Gan, Israel
Sourasky Medical Center
Status: Recruiting
Contact: Einat Shacham-Shmueli, MD - Einat.ShachamShmueli@sheba.health.gov.il
Tel-Aviv, Israel
Assaf Harofe Medical Center
Status: Recruiting
Contact: Ravit Geva, MD - ravitg@tasmc.health.gov.il
Zerifin, Israel
Status: Recruiting
Contact: Nirit Yarom, MD - nirit.yarom@asaf.health.gov.il
Start Date
January 2012
Completion Date
May 2015
Sponsors
Tiltan Pharma Ltd.
Source
Tiltan Pharma Ltd.
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page