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

Phase 2

• Conditions: Metastatic Pancreatic Cancer
• Interventions: Drug: TL-118; Drug: Gemcitabine

• Registration Number: NCT01509911
• Lead Sponsor: Tiltan Pharma Ltd.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-01-05
• Study First Submitted QC: 2012-01-12
• Study First Posted: 2012-01-13
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-04
• Last Update Posted: 2016-02-05
• Primary Completion: 2016-10
• Study Completion: 2017-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 99

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. -

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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 -

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TL-118 with standard of care Gemcitabine	TL-118	-
Gemcitabine with out TL-118	Gemcitabine	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Quality of life	Baseline to study completion
Response Rate	Measured at week 16
Overall Survival	Measured at week 16 and 52
Progression free survival	Measured at week 16 and 52

Trial Locations

Locations (10)

Soroka Medical Center; 🇮🇱 Be'er Sheva, Israel

HaEmek Medical Center; 🇮🇱 Afula, Israel

Sourasky Medical Center; 🇮🇱 Tel-Aviv, Israel

Assaf Harofe Medical Center; 🇮🇱 Zerifin, Israel

Sheba Medical Center; 🇮🇱 Ramat-Gan, Israel

Emory Clinic; 🇺🇸 Atlanta, Georgia, United States

White Plains Hospital; 🇺🇸 White Plains, New York, United States

Hadassah Medical Center; 🇮🇱 Jerusalem, Israel

Rambam Medical Center; 🇮🇱 Haifa, Israel

Hillel Yaffe Medical Center; 🇮🇱 Hadera, Israel