Investigator's Initiated Phase II Study for Pancreatic Cancer Patients
This study is not yet open for participant recruitment.
Verified December 2013 by Tiltan Pharma Ltd.
Tiltan Pharma Ltd.
Information provided by (Responsible Party):
Tzivia Berkman, Tiltan Pharma Ltd.
First received: July 23, 2012
Last updated: December 4, 2013
Last verified: December 2013
The purpose of this study is to evaluate the efficacy, safety and tolerability of TL-118 alone or in combination with pancreatic cancer chemotherapy.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Tiltan Pharma Ltd.:
Primary Outcome Measures:
- Clinical Benefit Measurement [ Time Frame: Baseline up to 2 years ] [ Designated as safety issue: No ]Clinical Benefit Measurement is a composite of measurements of pain (analgesic consumption and pain intensity), performance status and weight. Clinical benefit requires an improvement in at least one parameter, without worsening in any others, sustained for at least 4 weeks
Secondary Outcome Measures:
- Safety and tolerability [ Time Frame: Baseline up to 2 years ] [ Designated as safety issue: Yes ]
Safety and tolerability profiles will be judged by:
- Local and systemic toxicities.
- Number, type and degree of toxicities as measured by the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) v4.0
- Response Rate (RR) [ Time Frame: RR measured every 8 weeks after enrollment up to 2 years ] [ Designated as safety issue: No ]
- Overall Survival [ Time Frame: OS measured at 16 and 52 weeks after treatment initiation or at death, whichever comes first up to 2 years ] [ Designated as safety issue: No ]
- Progression Free Survival (PFS) [ Time Frame: PFS measured at 8 weeks after enrollment until the date of first documented progression or date of death, whichever comes first, up to 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||December 2013|
|Estimated Primary Completion Date:||October 2014 (Final data collection date for primary outcome measure)|
|Experimental: TL-118 alone or with pancreas cancer chemotherapy||
TL-118 investigational product is supplied as an oral liquid for daily administration at a specific dosing regimen. Treatment protocol includes weekly therapy cycles
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01659502
|Contact: Ayala Huberrt, MD||AyalaH@hadassah.org.il|
|Hadassah Medical Center||Not yet recruiting|
|Contact: Ayala Hubert, MD AyalaH@hadassah.org.il|
|Principal Investigator: Ayala Hubert, MD|
Sponsors and Collaborators
Tiltan Pharma Ltd.