Clinical trial NCT01509911: A Clinical Trial of Anti-Angiogenic Drug Combination Tl-118 for Pancreatic Cancer Patients Who Are Starting Gemcitabine Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Metastatic Pancreatic Cancer
Lead sponsor: Tiltan Pharma Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Technostat
name: Novatrials
First posted: 2012-01-13
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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 -

Primary outcomes:
measure: 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
timeFrame: 16 weeks after treatment initiation
Secondary outcomes:
measure: Response Rate
timeFrame: Measured at week 16
measure: Quality of life
timeFrame: Baseline to study completion
measure: Progression free survival
timeFrame: Measured at week 16 and 52
measure: Overall Survival
timeFrame: Measured at week 16 and 52
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory Clinic
state: Georgia
city: White Plains
country: United States
facility: White Plains Hospital
state: New York
city: Afula
country: Israel
facility: HaEmek Medical Center
city: Be'er Sheva
country: Israel
facility: Soroka Medical Center
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
city: Ramat-Gan
country: Israel
facility: Sheba Medical Center
city: Tel-Aviv
country: Israel
facility: Sourasky Medical Center
city: Zerifin
country: Israel
facility: Assaf Harofe Medical Center
Study officials:
References: