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
  Purpose

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


Condition Intervention Phase
Metastatic Pancreatic Cancer
Drug: TL-118
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Tiltan Pharma Ltd.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 80
Study Start Date: January 2012
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TL-118 with standard of care Gemcitabine 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.
No Intervention: Gemcitabine with out TL-118

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 -
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01509911

Contacts
Contact: Osnat Ohne, Phd +972-54-3133705 osnat@tiltanpharma.com
Contact: Tzivia Berkman, Ms.c +972-50-9442580 tzivia@tiltanpharma.com

Locations
United States, Georgia
Emory Clinic Not yet recruiting
Atlanta, Georgia, United States, 30322
Contact: Bassel El-Rayes, MD       Bassel.el-rayes@emoryhealthcare.org   
Principal Investigator: Bassel El-Rayes, MD         
United States, New York
White Plains Hospital Recruiting
White Plains, New York, United States, 10601
Contact: Dan Costin, MD       dancostin@witcbd.net   
Principal Investigator: Dan Costin, MD         
Israel
Soroka Medical Center Recruiting
Be'er Sheva, Israel
Contact: Sofia Man, MD       sman@bgu.ac.il   
Principal Investigator: Sofia Man, MD         
Hillel Yaffe Medical Center Not yet recruiting
Hadera, Israel, 38100
Contact: Katerina Shulman, MD       KaterinaS@hy.health.gov.il   
Principal Investigator: Katerina Shulman, MD         
Rambam Medical Center Recruiting
Haifa, Israel
Contact: Ron Epelbaum, MD       epelbaum@rambam.health.gov.il   
Principal Investigator: Ron Epelbaum, MD         
Hadassah Medical Center Recruiting
Jerusalem, Israel
Contact: Ayala Hubert, MD       AyalaH@hadassah.org.il   
Principal Investigator: Ayala Hubert, MD         
Sheba Medical Center Recruiting
Ramat-Gan, Israel
Contact: Einat Shacham-Shmueli, MD       Einat.ShachamShmueli@sheba.health.gov.il   
Principal Investigator: Einat Shacham-Shmueli, MD         
Sourasky Medical Center Recruiting
Tel-Aviv, Israel
Contact: Ravit Geva, MD       ravitg@tasmc.health.gov.il   
Principal Investigator: Ravit Geva, MD         
Assaf Harofe Medical Center Recruiting
Zerifin, Israel, 70300
Contact: Nirit Yarom, MD       nirit.yarom@asaf.health.gov.il   
Principal Investigator: Nirit Yarom, MD         
Sponsors and Collaborators
Tiltan Pharma Ltd.
  More Information

No publications provided

Responsible Party: Tiltan Pharma Ltd.
ClinicalTrials.gov Identifier: NCT01509911     History of Changes
Other Study ID Numbers: TLH-206
Study First Received: January 5, 2012
Last Updated: June 9, 2014
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Cimetidine
Diclofenac
Cyclophosphamide
Sulfasalazine
Angiogenesis Inhibitors
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors

ClinicalTrials.gov processed this record on August 27, 2014