Pancreatic CancerPhase 2NCT01659502
Investigator's Initiated Phase II Study for Pancreatic Cancer Patients
A Phase 2 study testing TL-118 in people with Pancreatic Cancer, run by Tiltan Pharma Ltd. at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- TL-118
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2013to Oct 2014
- 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.
- 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.
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- 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).
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Ayala Huberrt, MD contact
Israel1 site
Hadassah Medical Center
Jerusalem
Ayala Hubert, MD, AyalaH@hadassah.org.il
Ayala Hubert, MD
About this study
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
- Pancreatic Cancer
- Being tested
- TL-118
- Keywords
- Patients
- 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
| Study group | Role | What they receive |
|---|---|---|
| TL-118 alone or with pancreas cancer chemotherapy | Experimental | Not described Receives: Drug: TL-118 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline up to 2 years
Secondary outcomes (4)
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
Measured: Baseline up to 2 years
Response Rate (RR)
Measured: RR measured every 8 weeks after enrollment up to 2 years
Overall Survival
Measured: OS measured at 16 and 52 weeks after treatment initiation or at death, whichever comes first up to 2 years
Progression Free Survival (PFS)
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2012 (estimated)
- Study startDec 2013
- Primary completionOct 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tiltan Pharma Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Tzivia Berkman, Tiltan Pharma Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01659502
- Sponsor's protocol ID
- TLH-207
- Status last verified
- Dec 2013
- First submitted
- 23 Jul 2012
- Last updated
- 5 Dec 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigator's Initiated Phase II Study for Pancreatic Cancer Patients
- ClinicalTrials.gov ID
- NCT01659502
- Acronym / sponsor ID
- TLH-207
- Conditions
- Pancreatic Cancer
- Keywords
- Patients
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Tiltan Pharma Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Oct 2014 (estimated)
- First posted
- 7 Aug 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.
The purpose of this study is to evaluate the efficacy, safety and tolerability of TL-118 alone or in combination with pancreatic cancer chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TL-118 alone or with pancreas cancer chemotherapy | Experimental | Drug: TL-118 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (17 listed)
- 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.
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 alone or with pancreas cancer chemotherapy |
Primary outcome
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
4 secondary outcomes
Safety and tolerability
Time frame: Baseline up to 2 years
Response Rate (RR)
Time frame: RR measured every 8 weeks after enrollment up to 2 years
Overall Survival
Time frame: OS measured at 16 and 52 weeks after treatment initiation or at death, whichever comes first up to 2 years
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2013.
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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.
Ayala Huberrt, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TL-118 in people with Pancreatic Cancer, run by Tiltan Pharma Ltd. at 1 site in Israel.
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 11 inclusion and 17 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 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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?
Contact Ayala Huberrt, MD (AyalaH@hadassah.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Benefit Measurement (time frame: Baseline up to 2 years). 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 Dec 2013.