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

Metastatic Pancreatic Cancer Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01509911
• Other study ID #: TLH-206
• Status: Active, not recruiting
• Phase: Phase 2
• First received: January 5, 2012
• Last updated: February 4, 2016
• Start date: January 2012
• Est. completion date: January 2017

Study information

• Verified date: February 2016
• Source: Tiltan Pharma Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 99
• Est. completion date: January 2017
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metastatic Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

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.
• Gemcitabine
Monthly cycles of 3 weekly treatments a month and one week off of treatment

Locations

Country	Name	City	State
Israel	HaEmek Medical Center	Afula
Israel	Soroka Medical Center	Be'er Sheva
Israel	Hillel Yaffe Medical Center	Hadera
Israel	Rambam Medical Center	Haifa
Israel	Hadassah Medical Center	Jerusalem
Israel	Sheba Medical Center	Ramat-Gan
Israel	Sourasky Medical Center	Tel-Aviv
Israel	Assaf Harofe Medical Center	Zerifin
United States	Emory Clinic	Atlanta	Georgia
United States	White Plains Hospital	White Plains	New York

Sponsors (3)

Lead Sponsor	Collaborator
Tiltan Pharma Ltd.	Novatrials, Technostat

Countries where clinical trial is conducted

United States,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Response Rate		Measured at week 16	No
Secondary	Quality of life		Baseline to study completion	No
Secondary	Progression free survival		Measured at week 16 and 52	No
Secondary	Overall Survival		Measured at week 16 and 52	No