Investigator's Initiated Phase II Study for Pancreatic Cancer Patients

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy, safety and tolerability of TL-118 alone or in combination with pancreatic cancer chemotherapy.

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Drug: TL-118


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age at least 18 years at enrollment. Locally Advanced Pancreatic Cancer and/or Metastatic Pancreatic Cancer which failed to respond to one or two lines of chemotherapy The patient has histologically or cytologically confirmed pancreatic cancer. Patient has measurable disease by radiological imaging techniques as defined according to Response Evaluation Criteria in Solid Tumors (RECIST). ECOG performance status ≤ 2 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). Known CNS or Brain metastases Patient has received 3 or more different prior chemotherapies for the treatment of pancreatic cancer Any significant change in treatment within the 14 days before screening or an un-stable medical condition that may affect patient participation or evaluation in the study. Concurrent use of any other investigational product or within 28 days before study entry. Chronic treatment with: (a) immunosuppressive agent other than systemic corticosteroid, (b) patients who are under chronic treatment with NSAIDs with the exception of Aspirin at a daily dose ≤ 100mg. Use of supplements or complementary medicines/botanicals, except for conventional multivitamin supplements, calcium, selenium and soy supplements. Patients at increased risk of gastro intestinal bleeding such as patients with known active gastro intestinal ulcer, erosive gastritis or varices, as confirmed by gastroscopy performed within one year before screening. Serious or uncontrolled co-existent diseases that are likely to significantly increase the risks associated with TL-118 therapy (e.g. severe cardiovascular disease, congestive heart failure, recent myocardial infarction, significant vascular disease, active or uncontrolled autoimmune disease, active or uncontrolled infection). Patient has known historical or active infection with HIV, hepatitis B, or hepatitis C Serious or non-healing wound, ulcer or bone fracture. Circumstances likely to interfere with absorption of orally administrated drugs. History of noncompliance to medical regimens or coexisting conditions precluding full compliance with study protocol, or any other condition that in the discretion of the Investigator may preclude safe and complete study participation. Subjects unwilling or unable to comply with study protocol. Know pregnancy or breast-feeding women. Women of child bearing potential not exercising two methods of contraception.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TL-118 alone or with pancreas cancer chemotherapy<br> | Drug: TL-118<br>* TL-118 investigational product is supplied as an oral liquid for daily administration at a specific dosing regimen. Treatment protocol includes weekly therapy cycles<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Benefit Measurement | 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 | Baseline up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability | 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 | Baseline up to 2 years | 
| Response Rate (RR) |  | RR measured every 8 weeks after enrollment up to 2 years | 
| Overall Survival |  | OS measured at 16 and 52 weeks after treatment initiation or at death, whichever comes first up to 2 years | 
| Progression Free Survival (PFS) |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patients