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.
Verified April 2013 by Tiltan Pharma Ltd.
Sponsor:
Tiltan Pharma Ltd.
Information provided by (Responsible Party):
Tiltan Pharma Ltd.
ClinicalTrials.gov Identifier:
NCT01509911
First received: January 5, 2012
Last updated: April 29, 2013
Last verified: April 2013
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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: | January 2014 |
| Estimated Primary Completion Date: | January 2014 (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:
- Age at least 18 years at enrollment.
- Metastatic Pancreatic Cancer
- The patient has histologically or cytologically confirmed pancreatic adenocarcinoma.
- Patient has measurable disease by (RECIST).
- Patient is starting standard of care Gemcitabine treatment
- ECOG performance status ≤ 1
- Adequate renal function
- Adequate hepatic function
- Adequate bone marrow reserve
- Resolution of prior therapy acute adverse events.
- Patient is capable of swallowing.
- Patient's Informed Consent. -
Exclusion Criteria:
- Hypersensitivity to one or more of the TL-118 active components
- Known Glucose-6-phosphate-dehydrogenase deficiency (G6PD).
- CNS or Brain metastases
- Prior systemic therapy for pancreas cancer
- Subjects who received any investigational medication, prior local therapy for pancreas cancer , or any significant change in treatment within 1 month prior to screening
- Concurrent use of any other investigational product
- Subjects with a clinically significant or unstable medical condition that would preclude safe and complete study participation
- Use of supplements or complementary medicines/botanicals, except for conventional multivitamin supplements, calcium, selenium and soy supplements.
- Patient has known historical or active infection with HIV, hepatitis B, or hepatitis C
- Circumstances likely to interfere with absorption of orally administrated drugs.
- History of noncompliance to medical regimens or coexisting -
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01509911
Contacts
| Contact: Dan Goldstaub, Phd | +972-54-5558573 | dan@tiltanpharma.com |
Locations
| 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 | |
| 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: | April 29, 2013 |
| 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 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 May 16, 2013