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

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

Study Overview

• Status: Unknown
• Conditions: Metastatic Pancreatic Cancer
• Intervention / Treatment: Drug: TL-118; Drug: Gemcitabine

• Study Type: Interventional
• Enrollment (Actual): 99
• Phase: Phase 2

Contacts and Locations

Study Locations

• Israel
  • Afula, Israel
    • Haemek Medical Center
  • Be'er Sheva, Israel
    • Soroka Medical Center
  • Hadera, Israel, 38100
    • Hillel Yaffe Medical Center
  • Haifa, Israel
    • Rambam Medical Center
  • Jerusalem, Israel
    • Hadassah Medical Center
  • Ramat-Gan, Israel
    • Sheba Medical Center
  • Tel-Aviv, Israel
    • Sourasky Medical Center
  • Zerifin, Israel, 70300
    • Assaf Harofe Medical Center
• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory Clinic
  • New York
    • White Plains, New York, United States, 10601
      • White Plains Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TL-118 with standard of care Gemcitabine	Drug: 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.
Active Comparator: Gemcitabine with out TL-118	Drug: Gemcitabine; Monthly cycles of 3 weekly treatments a month and one week off of treatment; Other Names: Gemzar

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Tiltan Pharma Ltd.
• Collaborators: Technostat; Novatrials

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Anticipated): October 1, 2016
• Study Completion (Anticipated): January 1, 2017

Study Registration Dates

• First Submitted: January 5, 2012
• First Submitted That Met QC Criteria: January 12, 2012
• First Posted (Estimate): January 13, 2012

Study Record Updates

• Last Update Posted (Estimate): February 5, 2016
• Last Update Submitted That Met QC Criteria: February 4, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Gemcitabine
• Other Study ID Numbers: TLH-206