Investigator's Initiated Phase II Study for Pancreatic Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01659502
Recruitment Status : Unknown
Verified December 2013 by Tzivia Berkman, Tiltan Pharma Ltd..
Recruitment status was:  Not yet recruiting
First Posted : August 7, 2012
Last Update Posted : December 5, 2013
Information provided by (Responsible Party):
Tzivia Berkman, Tiltan Pharma Ltd.

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

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: TL-118 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : December 2013
Estimated Primary Completion Date : October 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: TL-118 alone or with pancreas cancer chemotherapy 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

Primary Outcome Measures :
  1. Clinical Benefit Measurement [ Time Frame: Baseline up to 2 years ]
    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 :
  1. Safety and tolerability [ Time Frame: Baseline up to 2 years ]

    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

  2. Response Rate (RR) [ Time Frame: RR measured every 8 weeks after enrollment up to 2 years ]
  3. Overall Survival [ Time Frame: OS measured at 16 and 52 weeks after treatment initiation or at death, whichever comes first up to 2 years ]
  4. 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 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Age at least 18 years at enrollment.
  2. Locally Advanced Pancreatic Cancer and/or Metastatic Pancreatic Cancer which failed to respond to one or two lines of chemotherapy
  3. The patient has histologically or cytologically confirmed pancreatic cancer.
  4. Patient has measurable disease by radiological imaging techniques as defined according to Response Evaluation Criteria in Solid Tumors (RECIST).
  5. ECOG performance status ≤ 2
  6. Adequate renal function.
  7. Adequate hepatic function
  8. Adequate bone marrow reserve -
  9. Resolution of prior therapy acute adverse events.
  10. Patient is capable of swallowing.
  11. 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. Known CNS or Brain metastases
  4. Patient has received 3 or more different prior chemotherapies for the treatment of pancreatic cancer
  5. 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.
  6. Concurrent use of any other investigational product or within 28 days before study entry.
  7. 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.
  8. Use of supplements or complementary medicines/botanicals, except for conventional multivitamin supplements, calcium, selenium and soy supplements.
  9. 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.
  10. 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).
  11. Patient has known historical or active infection with HIV, hepatitis B, or hepatitis C
  12. Serious or non-healing wound, ulcer or bone fracture.
  13. Circumstances likely to interfere with absorption of orally administrated drugs.
  14. 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.
  15. Subjects unwilling or unable to comply with study protocol.
  16. Know pregnancy or breast-feeding women.
  17. Women of child bearing potential not exercising two methods of contraception.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01659502

Contact: Ayala Huberrt, MD

Hadassah Medical Center Not yet recruiting
Jerusalem, Israel
Contact: Ayala Hubert, MD   
Principal Investigator: Ayala Hubert, MD         
Sponsors and Collaborators
Tiltan Pharma Ltd.

Responsible Party: Tzivia Berkman, Dr Ayala Hubert, Tiltan Pharma Ltd. Identifier: NCT01659502     History of Changes
Other Study ID Numbers: TLH-207
First Posted: August 7, 2012    Key Record Dates
Last Update Posted: December 5, 2013
Last Verified: December 2013

Keywords provided by Tzivia Berkman, Tiltan Pharma Ltd.:

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases