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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01509911
Recruitment Status : Unknown
Verified February 2016 by Tiltan Pharma Ltd..
Recruitment status was:  Active, not recruiting
First Posted : January 13, 2012
Last Update Posted : February 5, 2016
Information provided by (Responsible Party):
Tiltan Pharma Ltd.

January 5, 2012
January 13, 2012
February 5, 2016
January 2012
October 2016   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01509911 on Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
A Clinical Trial of Anti-Angiogenic Drug Combination Tl-118 for Pancreatic Cancer Patients Who Are Starting Gemcitabine Treatment
Not Provided
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
Not Provided
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Metastatic Pancreatic Cancer
  • 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.
  • Drug: Gemcitabine
    Monthly cycles of 3 weekly treatments a month and one week off of treatment
    Other Name: Gemzar
  • Experimental: TL-118 with standard of care Gemcitabine
    Intervention: Drug: TL-118
  • Active Comparator: Gemcitabine with out TL-118
    Intervention: Drug: Gemcitabine
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
January 2017
October 2016   (Final data collection date for primary outcome measure)

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 -
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Israel,   United States
Not Provided
Not Provided
Not Provided
Tiltan Pharma Ltd.
Tiltan Pharma Ltd.
  • Technostat
  • Novatrials
Not Provided
Tiltan Pharma Ltd.
February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP