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Status unknownNCT01509911Updated Feb 5, 2016

A Clinical Trial of Anti-Angiogenic Drug Combination Tl-118 for Pancreatic Cancer Patients Who Are Starting Gemcitabine Treatment

A Phase 2 interventional study of TL-118 and Gemcitabine in Metastatic Pancreatic Cancer, sponsored by Tiltan Pharma Ltd.. Status unknown at 10 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-02-05.

Sponsored by Tiltan Pharma Ltd. · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2016), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
99
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

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Conditions studied

  • Metastatic Pancreatic Cancer
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In context

Pancreatic Neoplasms

3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.

This study's enrollment of 99 is above the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.

Browse Pancreatic Neoplasms studies →

Lead sponsor

Tiltan Pharma Ltd. is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age at least 18 years at enrollment.
  2. Metastatic Pancreatic Cancer
  3. The patient has histologically or cytologically confirmed pancreatic adenocarcinoma.
  4. Patient has measurable disease by (RECIST).
  5. Patient is starting standard of care Gemcitabine treatment
  6. ECOG performance status ≤ 1
  7. Adequate renal function
  8. Adequate hepatic function
  9. Adequate bone marrow reserve
  10. Resolution of prior therapy acute adverse events.
  11. Patient is capable of swallowing.
  12. Patient's Informed Consent. -

Exclusion criteria

Exclusion Criteria:

  1. Hypersensitivity to one or more of the TL-118 active components
  2. Known Glucose-6-phosphate-dehydrogenase deficiency (G6PD).
  3. CNS or Brain metastases
  4. Prior systemic therapy for pancreas cancer
  5. Subjects who received any investigational medication, prior local therapy for pancreas cancer , or any significant change in treatment within 1 month prior to screening
  6. Concurrent use of any other investigational product
  7. Subjects with a clinically significant or unstable medical condition that would preclude safe and complete study participation
  8. Use of supplements or complementary medicines/botanicals, except for conventional multivitamin supplements, calcium, selenium and soy supplements.
  9. Patient has known historical or active infection with HIV, hepatitis B, or hepatitis C
  10. Circumstances likely to interfere with absorption of orally administrated drugs.
  11. History of noncompliance to medical regimens or coexisting -
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
99 participants (actual)

Study arms

  • Experimental
    TL-118 with standard of care Gemcitabine

    Drug: TL-118

  • Active comparator
    Gemcitabine with out TL-118

    Drug: Gemcitabine

Interventions

  • DrugTL-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.

  • DrugGemcitabine

    Monthly cycles of 3 weekly treatments a month and one week off of treatment

    Also known as: Gemzar

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What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. Response Rate

    Time frame: Measured at week 16

  2. Quality of life

    Time frame: Baseline to study completion

  3. Progression free survival

    Time frame: Measured at week 16 and 52

  4. Overall Survival

    Time frame: Measured at week 16 and 52

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Study locations

10 sites
  • Emory Clinic
    Atlanta, Georgia 30322, United States
  • White Plains Hospital
    White Plains, New York 10601, United States
  • HaEmek Medical Center
    Afula, Israel
  • Soroka Medical Center
    Be'er Sheva, Israel
  • Hillel Yaffe Medical Center
    Hadera, 38100, Israel
  • Rambam Medical Center
    Haifa, Israel
  • Hadassah Medical Center
    Jerusalem, Israel
  • Sheba Medical Center
    Ramat-Gan, Israel
  • Sourasky Medical Center
    Tel-Aviv, Israel
  • Assaf Harofe Medical Center
    Zerifin, 70300, Israel
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 5, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01509911
Lead sponsor
Tiltan Pharma Ltd.
Collaborators
Technostat, Novatrials
Responsible party
Sponsor
First posted
Jan 13, 2012
Start date
Jan 2012
Primary completion
Oct 2016 (estimated)
Completion
Jan 2017 (estimated)
Last update
Feb 5, 2016
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.

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