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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Tiltan Pharma Ltd.
Sponsor:
Information provided by (Responsible Party):
Tiltan Pharma Ltd.
ClinicalTrials.gov Identifier:
NCT01509911
First received: January 5, 2012
Last updated: June 9, 2014
Last verified: June 2014

January 5, 2012
June 9, 2014
January 2012
May 2015   (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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01509911 on ClinicalTrials.gov Archive Site
  • Response Rate [ Time Frame: Measured at week 16 ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: Baseline to study completion ] [ Designated as safety issue: No ]
  • Progression free survival [ Time Frame: Measured at week 16 and 52 ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: Measured at week 16 and 52 ] [ Designated as safety issue: No ]
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
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.
  • Experimental: TL-118 with standard of care Gemcitabine
    Intervention: Drug: TL-118
  • No Intervention: Gemcitabine with out TL-118
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
May 2015
May 2015   (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 -
Both
18 Years and older
No
Contact: Osnat Ohne, Phd +972-54-3133705 osnat@tiltanpharma.com
Contact: Tzivia Berkman, Ms.c +972-50-9442580 tzivia@tiltanpharma.com
United States,   Israel
 
NCT01509911
TLH-206
Not Provided
Tiltan Pharma Ltd.
Tiltan Pharma Ltd.
Not Provided
Not Provided
Tiltan Pharma Ltd.
June 2014

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