A Clinical Trial of Anti-Angiogenic Drug Combination Tl-118 for Pancreatic Cancer Patients Who Are Starting Gemcitabine Treatment

Trial Title: A Clinical Trial of Anti-Angiogenic Drug Combination Tl-118 for Pancreatic Cancer Patients Who Are Starting Gemcitabine Treatment

NCT ID: NCT01509911

Condition: Metastatic Pancreatic Cancer

Conditions: Official terms:
Pancreatic Neoplasms
Gemcitabine

Study type: Interventional

Study phase: Phase 2

Overall status: Unknown status

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: TL-118
Description: TL-118 investigational product is supplied as an oral liquid for daily administration at a specific dosing regimen. Treatment protocol includes weekly therapy cycles.
Arm group label: TL-118 with standard of care Gemcitabine

Intervention type: Drug
Intervention name: Gemcitabine
Description: Monthly cycles of 3 weekly treatments a month and one week off of treatment
Arm group label: Gemcitabine with out TL-118

Other name: Gemzar

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:
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 -

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Emory Clinic

Address:
City: Atlanta
Zip: 30322
Country: United States

Facility:
Name: White Plains Hospital

Address:
City: White Plains
Zip: 10601
Country: United States

Facility:
Name: HaEmek Medical Center

Address:
City: Afula
Country: Israel

Facility:
Name: Soroka Medical Center

Address:
City: Be'er Sheva
Country: Israel

Facility:
Name: Hillel Yaffe Medical Center

Address:
City: Hadera
Zip: 38100
Country: Israel

Facility:
Name: Rambam Medical Center

Address:
City: Haifa
Country: Israel

Facility:
Name: Hadassah Medical Center

Address:
City: Jerusalem
Country: Israel

Facility:
Name: Sheba Medical Center

Address:
City: Ramat-Gan
Country: Israel

Facility:
Name: Sourasky Medical Center

Address:
City: Tel-Aviv
Country: Israel

Facility:
Name: Assaf Harofe Medical Center

Address:
City: Zerifin
Zip: 70300
Country: Israel

Start date: January 2012

Completion date: January 2017

Lead sponsor:
Agency: Tiltan Pharma Ltd.
Agency class: Industry

Collaborator:
Agency: Technostat
Agency class: Other

Collaborator:
Agency: Novatrials
Agency class: Other

Source: Tiltan Pharma Ltd.

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT01509911