This trial is active, not recruiting.

Condition metastatic pancreatic cancer
Treatments tl-118, gemcitabine
Phase phase 2
Sponsor Tiltan Pharma Ltd.
Collaborator Technostat
Start date January 2012
End date October 2016
Trial size 99 participants
Trial identifier NCT01509911, TLH-206


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
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 Gemzar
Monthly cycles of 3 weekly treatments a month and one week off of treatment

Primary Outcomes

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
time frame: 16 weeks after treatment initiation

Secondary Outcomes

Response Rate
time frame: Measured at week 16
Quality of life
time frame: Baseline to study completion
Progression free survival
time frame: Measured at week 16 and 52
Overall Survival
time frame: Measured at week 16 and 52

Eligibility Criteria

Male or female participants at least 18 years old.

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 -

Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Tiltan Pharma Ltd..
Location data was received from the National Cancer Institute and was last updated in February 2016.