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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Technostat
Novatrials
Information provided by (Responsible Party):
Tiltan Pharma Ltd.
ClinicalTrials.gov Identifier:
NCT01509911
First received: January 5, 2012
Last updated: February 4, 2016
Last verified: February 2016
  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 Drug: Gemcitabine Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 99
Study Start Date: January 2012
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: October 2016 (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.
Active Comparator: Gemcitabine with out TL-118 Drug: Gemcitabine
Monthly cycles of 3 weekly treatments a month and one week off of treatment
Other Name: Gemzar

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Locations
United States, Georgia
Emory Clinic
Atlanta, Georgia, United States, 30322
United States, New York
White Plains Hospital
White Plains, New York, United States, 10601
Israel
HaEmek Medical Center
Afula, Israel
Soroka Medical Center
Be'er Sheva, Israel
Hillel Yaffe Medical Center
Hadera, Israel, 38100
Rambam Medical Center
Haifa, Israel
Hadassah Medical Center
Jerusalem, Israel
Sheba Medical Center
Ramat-Gan, Israel
Sourasky Medical Center
Tel-Aviv, Israel
Assaf Harofe Medical Center
Zerifin, Israel, 70300
Sponsors and Collaborators
Tiltan Pharma Ltd.
Technostat
Novatrials
  More Information

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: February 4, 2016

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
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 16, 2017