Metastatic Pancreatic CancerPhase 2NCT01509911
A Clinical Trial of Anti-Angiogenic Drug Combination Tl-118 for Pancreatic Cancer Patients Who Are Starting Gemcitabine Treatment
A Phase 2 study testing TL-118 and Gemcitabine in people with Metastatic Pancreatic Cancer, run by Tiltan Pharma Ltd. at 10 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Pancreatic Cancer
- What is being tested?
- TL-118 and Gemcitabine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 10 sitesin 2 countries
- Study dates
- Jan 2012to Jan 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age at least 18 years at enrollment.
- Metastatic Pancreatic Cancer
- The patient has histologically or cytologically confirmed pancreatic adenocarcinoma.
- Patient has measurable disease by (RECIST).
- Patient is starting standard of care Gemcitabine treatment
- ECOG performance status ≤ 1
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- 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. -
Who cannot join
- Hypersensitivity to one or more of the TL-118 active components
- Known Glucose-6-phosphate-dehydrogenase deficiency (G6PD).
- CNS or Brain metastases
- Prior systemic therapy for pancreas cancer
- Subjects who received any investigational medication, prior local therapy for pancreas cancer , or any significant change in treatment within 1 month prior to screening
- Concurrent use of any other investigational product
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- Subjects with a clinically significant or unstable medical condition that would preclude safe and complete study participation
- Use of supplements or complementary medicines/botanicals, except for conventional multivitamin supplements, calcium, selenium and soy supplements.
- Patient has known historical or active infection with HIV, hepatitis B, or hepatitis C
- Circumstances likely to interfere with absorption of orally administrated drugs.
- History of noncompliance to medical regimens or coexisting -
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
Israel8 sites
HaEmek Medical Center
Afula
Soroka Medical Center
Beersheba
Hillel Yaffe Medical Center
Hadera, 38100
Rambam Medical Center
Haifa
Hadassah Medical Center
Jerusalem
Sheba Medical Center
Ramat Gan
Sourasky Medical Center
Tel Aviv
Assaf Harofe Medical Center
Tsrifin, Zerifin, 70300
United States2 sites
Emory Clinic
Atlanta, Georgia, 30322
White Plains Hospital
White Plains, New York, 10601
About this study
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
- Conditions
- Metastatic Pancreatic Cancer
- Being tested
- TL-118, Gemcitabine
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TL-118Drug
TL-118 investigational product is supplied as an oral liquid for daily administration at a specific dosing regimen. Treatment protocol includes weekly therapy cycles.
GemcitabineDrug
Also called Gemzar
Monthly cycles of 3 weekly treatments a month and one week off of treatment
| Study group | Role | What they receive |
|---|---|---|
| TL-118 with standard of care Gemcitabine | Experimental | Not described Receives: Drug: TL-118 |
| Gemcitabine with out TL-118 | Active comparator | Not described Receives: Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 16 weeks after treatment initiation
Secondary outcomes (4)
Response Rate
Measured: Measured at week 16
Quality of life
Measured: Baseline to study completion
Progression free survival
Measured: Measured at week 16 and 52
Overall Survival
Measured: Measured at week 16 and 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionOct 2016 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tiltan Pharma Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Technostat, Novatrials
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01509911
- Sponsor's protocol ID
- TLH-206
- Status last verified
- Feb 2016
- First submitted
- 5 Jan 2012
- Last updated
- 5 Feb 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial of Anti-Angiogenic Drug Combination Tl-118 for Pancreatic Cancer Patients Who Are Starting Gemcitabine Treatment
- ClinicalTrials.gov ID
- NCT01509911
- Acronym / sponsor ID
- TLH-206
- Conditions
- Metastatic Pancreatic Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Tiltan Pharma Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Technostat, Novatrials
- Study start
- Jan 2012
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 13 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TL-118 with standard of care Gemcitabine | Experimental | Drug: TL-118 |
| Gemcitabine with out TL-118 | Active comparator | Drug: Gemcitabine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age at least 18 years at enrollment.
- Metastatic Pancreatic Cancer
- The patient has histologically or cytologically confirmed pancreatic adenocarcinoma.
- Patient has measurable disease by (RECIST).
- Patient is starting standard of care Gemcitabine treatment
Key exclusion criteria (11 listed)
- Hypersensitivity to one or more of the TL-118 active components
- Known Glucose-6-phosphate-dehydrogenase deficiency (G6PD).
- CNS or Brain metastases
- Prior systemic therapy for pancreas cancer
- Subjects who received any investigational medication, prior local therapy for pancreas cancer , or any significant change in treatment within 1 month prior to screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TL-118TL-118 investigational product is supplied as an oral liquid for daily administration at a specific dosing regimen. Treatment protocol includes weekly therapy cycles. | Drug | TL-118 with standard of care Gemcitabine |
| GemcitabineAlso: GemzarMonthly cycles of 3 weekly treatments a month and one week off of treatment | Drug | Gemcitabine with out TL-118 |
Primary outcome
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
4 secondary outcomes
Response Rate
Time frame: Measured at week 16
Quality of life
Time frame: Baseline to study completion
Progression free survival
Time frame: Measured at week 16 and 52
Overall Survival
Time frame: Measured at week 16 and 52
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TL-118 and Gemcitabine in people with Metastatic Pancreatic Cancer, run by Tiltan Pharma Ltd. at 10 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Israel, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2016.