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Investigator's Initiated Phase II Study for Pancreatic Cancer Patients

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified December 2013 by Tiltan Pharma Ltd.
Sponsor:
Information provided by (Responsible Party):
Tzivia Berkman, Tiltan Pharma Ltd.
ClinicalTrials.gov Identifier:
NCT01659502
First received: July 23, 2012
Last updated: December 4, 2013
Last verified: December 2013
  Purpose

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 Intervention Phase
Pancreatic Cancer
Drug: TL-118
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


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 ]

Estimated Enrollment: 10
Study Start Date: December 2013
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT01659502

Contacts
Contact: Ayala Huberrt, MD AyalaH@hadassah.org.il

Locations
Israel
Hadassah Medical Center Not yet recruiting
Jerusalem, Israel
Contact: Ayala Hubert, MD       AyalaH@hadassah.org.il   
Principal Investigator: Ayala Hubert, MD         
Sponsors and Collaborators
Tiltan Pharma Ltd.
  More Information

No publications provided

Responsible Party: Tzivia Berkman, Dr Ayala Hubert, Tiltan Pharma Ltd.
ClinicalTrials.gov Identifier: NCT01659502     History of Changes
Other Study ID Numbers: TLH-207
Study First Received: July 23, 2012
Last Updated: December 4, 2013
Health Authority: Israel: Ministry of Health

Keywords provided by Tiltan Pharma Ltd.:
Patients

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

ClinicalTrials.gov processed this record on November 25, 2014