Patients w/Advanced Cancer That Failed Std of Care TherapyPhase 1/2NCT02138955
A Phase IB Dose Escalation Study of Lipocurc in Patients With Cancer
A Phase 1/2 study testing Liposomeal curcumin in people with Patients w/Advanced Cancer That Failed Std of Care Therapy, run by SignPath Pharma, Inc. at 2 sites in Austria.
Trial summary
This is a single center in patient/outpatient, uncontrolled dose escalating study in cancer patients to evaluate the safety, tolerability and pharmacokinetic (PK) profiles of body surface area adjusted doses of liposomal curcumin administered intravenously as an 8 hour infusion once weekly for 8 weeks. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Patients w/Advanced Cancer That Failed Std of Care Therapy
- What is being tested?
- Liposomeal curcumin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesAustria
- Study dates
- Mar 2014to 15 Feb 2018
- Phase
- Phase 1/2
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and Female patients >18 years with a histologically/cytologically confirmed diagnosis of locally advanced or metastatic cancer ,for whom no anti-tumor therapy of proven benefit is available at study enrollment.
- ECOG 0-2.
- Life expectancy of at least 3 months.
- Measurable or non-measurable disease according to RECIST v1.1 criteria.
- Patients should have at least one measurable lesion or disease which is non-measurable but can be clearly be evaluated for response.
- Adequate bone marrow function as evidenced by an absolute neutrophil count :1500 cell/ul.
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- Hb greater than 9.5 g/dL and a platelet count greater than 100,000/ uL.
- Renal function >50ml/min with estimated creatinine clearance (eCcr) using the Cockcroft-Gault formula or serum creatinine<1.5 mg/dL.
- Adequate hepatic function as evidenced by serum total bilirubin <3.0 mg/dL, and AST and ALT less than 5 times the upper limit of normal(ULN).
- Signed informed consent.
Who cannot join
- Patients with lymphoma, hematological cancer or glioblastoma multiforme.
- Active infection, or a fever >38.5C within three days prior to the first day of study drug dosing.
- Current or past history evidence of disease (hemolytic diathesis, hemochromatosis) that could be exacerbated by administering liposomal curcumin.
- Currently on coumadin or coumadin derivatives(oral anticoagulants), or any medications classified as cytochrome p450 inhibitors or inducers.
- Last systemic therapy less than three(3) weeks before (six weeks if treatment was with BCNU or CCNU).
- Unresolved toxicities from prior systemic anti-cancer therapy except symptomatic motor or sensory neuro-toxicities NCI-CTC Grade <2.
- Clinically significant ECG aberrations according to the discretion of the investigator.
- Left ventricular ejection fraction (LVEF) <50%.
Trial locations and contacts
2 sites in 1 country.
Austria2 sites
3 Medicizinische Universitatsklinik Hematologie,Internistische Onkologie
Salzburg, 5020
3. Medizinische Universitatesclinik, Haematologie, Internistische Onkologie
Salzburg, 5020
About this study
Official title: : A PHASE Ib DOSE ESCALATION STUDY ON THE SAFETY, TOLERABILITY AND ACTIVITY OF LIPOSOMAL CURCUMIN IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC CANCER
This is a single center in patient/outpatient, uncontrolled dose escalating study in cancer patients to evaluate the safety, tolerability and pharmacokinetic (PK) profiles of body surface area adjusted doses of liposomal curcumin administered intravenously as an 8 hour infusion once weekly for 8 weeks.
Read the detailed description
Patients with solid tumors who either failed to initially respond to approved chemotherapy or who have progressive solid tumor cancers following initial response to approved chemotherapy, are eligible for treatment in this phase 1b trial of ascending doses of intravenous liposomal curcumin following a four week period without previous chemotherapy.The escalating dose range of liposomal curcumin will be from 100mg/M2 to 300 mg/M2 in cohorts of three to 6 patients, and administered over eight hours by a syringe pump weekly for eight weeks. Safety and tolerability will be determined by drug related adverse symptoms(if any), hematologic and serologic signs at each clinic visit and by electronic communication between visits. Pharmacokinetic profiles following infusion of drug will be compared with any adverse changes, and any beneficial subjective or objective responses. When the maximum tolerated dose level is reached in any cohort , another three patients will be accrued at a preceding dose level to assure tolerability in subsequent phase 2 clinical trials.
- Being tested
- Liposomeal curcumin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomeal curcuminDrug
| Study group | Role | What they receive |
|---|---|---|
| Liposomeal curcumin ascending dose phase 1b | Experimental | Not described Receives: Drug: Liposomeal curcumin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicity with focus on hemolysis
The primary objectives of this study are to determine in cancer patients the safety profile of increasing doses of intravenous liposomal curcumin until the maximum tolerated dose (MTD) is determined. This will be done by assessing clinical chemistry, hematology, EKGs and urine analyses, signs and physical symptoms of adverse events.
Measured: Eight(8) weeks
Determine the maximum tolerated dose of lipocurc
The primary objectives of this study are to determine in cancer patients the safety profile of increasing doses of intravenous liposomal curcumin until the maximum tolerated dose (MTD) is determined. This will be done by assessing clinical chemistry, hematology, EKGs and urine analyses, signs and physical symptoms of adverse events.
Measured: in the cohort after eight ( 8) weeks of treatment
Maximum tolerated dose
The primary objectives of this study are to determine in cancer patients the safety profile of increasing doses of intravenous liposomal curcumin until the maximum tolerated dose (MTD) is determined. This will be done by assessing clinical chemistry, hematology, EKGs and urine analyses, signs and physical symptoms of adverse events.
Measured: eight(8) weeks
Maximum tolerated dose defined by < Grade 1 hematologic toxicity,
The MTD is reached when two or more patients (out of 6) at a dose level experience DLT.
Measured: Outcome measured weekly x 8 weeks
Secondary outcomes (5)
Response by Recist criteria
The secondary objectives are to determine the PK profiles of increasing doses, up to the MTD of liposomal curcumin, and to record any evidence of beneficial effect associated with the treatment.
Measured: Eight(8) weeks
Tumor response by resist criteria
The secondary objectives are to determine the PK profiles of increasing doses, up to the MTD of liposomal curcumin, and to record any evidence of beneficial effect associated with the treatment.
Measured: 8 weeks
Tumor response
The secondary objectives are to determine the PK profiles of increasing doses, up to the MTD of liposomal curcumin, and to record any evidence of beneficial effect associated with the treatment.
Measured: Eight weeks
Benefit
The secondary objectives are to determine the PK profiles of increasing doses, up to the MTD of liposomal curcumin, and to record any evidence of related beneficial effect associated with the treatment.
Measured: Eight(8) weeks
Objective change in measurable tumor size by Resist criteria
Measured: once after 8 weeky treatments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2014 (estimated)
- Study startMar 2014
- Primary completion30 Nov 2017
- Study completion15 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients w/Advanced Cancer That Failed Std of Care TherapyStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- SignPath Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard Greil, MD, Principal investigator, Medicizinische Universitatsklinik Hematologie,Internistische Onkologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02138955
- Sponsor's protocol ID
- Lipocurc1002/P-1-010
- Other IDs
- 0011594-24, SPP1002, 2013-001594-24
- Status last verified
- May 2017
- First submitted
- 14 May 2014
- Last updated
- 11 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- : A PHASE Ib DOSE ESCALATION STUDY ON THE SAFETY, TOLERABILITY AND ACTIVITY OF LIPOSOMAL CURCUMIN IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC CANCER
- ClinicalTrials.gov ID
- NCT02138955
- Acronym / sponsor ID
- Lipocurc1002/P-1-010
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- SignPath Pharma, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- 30 Nov 2017 (actual)
- Study completion
- 15 Feb 2018 (actual)
- First posted
- 15 May 2014 (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.
This is a single center in patient/outpatient, uncontrolled dose escalating study in cancer patients to evaluate the safety, tolerability and pharmacokinetic (PK) profiles of body surface area adjusted doses of liposomal curcumin administered intravenously as an 8 hour infusion once weekly for 8 weeks.
Detailed description
Patients with solid tumors who either failed to initially respond to approved chemotherapy or who have progressive solid tumor cancers following initial response to approved chemotherapy, are eligible for treatment in this phase 1b trial of ascending doses of intravenous liposomal curcumin following a four week period without previous chemotherapy.The escalating dose range of liposomal curcumin will be from 100mg/M2 to 300 mg/M2 in cohorts of three to 6 patients, and administered over eight hours by a syringe pump weekly for eight weeks. Safety and tolerability will be determined by drug related adverse symptoms(if any), hematologic and serologic signs at each clinic visit and by electronic communication between visits. Pharmacokinetic profiles following infusion of drug will be compared with any adverse changes, and any beneficial subjective or objective responses. When the maximum tolerated dose level is reached in any cohort , another three patients will be accrued at a preceding dose level to assure tolerability in subsequent phase 2 clinical trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liposomeal curcumin ascending dose phase 1b | Experimental | Drug: Liposomeal curcumin |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male and Female patients >18 years with a histologically/cytologically confirmed diagnosis of locally advanced or metastatic cancer ,for whom no anti-tumor therapy of proven benefit is available at study enrollment.
- ECOG 0-2.
- Life expectancy of at least 3 months.
- Measurable or non-measurable disease according to RECIST v1.1 criteria.
- Patients should have at least one measurable lesion or disease which is non-measurable but can be clearly be evaluated for response.
Key exclusion criteria (8 listed)
- Patients with lymphoma, hematological cancer or glioblastoma multiforme.
- Active infection, or a fever >38.5C within three days prior to the first day of study drug dosing.
- Current or past history evidence of disease (hemolytic diathesis, hemochromatosis) that could be exacerbated by administering liposomal curcumin.
- Currently on coumadin or coumadin derivatives(oral anticoagulants), or any medications classified as cytochrome p450 inhibitors or inducers.
- Last systemic therapy less than three(3) weeks before (six weeks if treatment was with BCNU or CCNU).
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 |
|---|---|---|
| Liposomeal curcumin | Drug | Liposomeal curcumin ascending dose phase 1b |
Primary outcome
Dose limiting toxicity with focus on hemolysis
Time frame: Eight(8) weeks
The primary objectives of this study are to determine in cancer patients the safety profile of increasing doses of intravenous liposomal curcumin until the maximum tolerated dose (MTD) is determined. This will be done by assessing clinical chemistry, hematology, EKGs and urine analyses, signs and physical symptoms of adverse events.
Determine the maximum tolerated dose of lipocurc
Time frame: in the cohort after eight ( 8) weeks of treatment
The primary objectives of this study are to determine in cancer patients the safety profile of increasing doses of intravenous liposomal curcumin until the maximum tolerated dose (MTD) is determined. This will be done by assessing clinical chemistry, hematology, EKGs and urine analyses, signs and physical symptoms of adverse events.
Maximum tolerated dose
Time frame: eight(8) weeks
The primary objectives of this study are to determine in cancer patients the safety profile of increasing doses of intravenous liposomal curcumin until the maximum tolerated dose (MTD) is determined. This will be done by assessing clinical chemistry, hematology, EKGs and urine analyses, signs and physical symptoms of adverse events.
Maximum tolerated dose defined by < Grade 1 hematologic toxicity,
Time frame: Outcome measured weekly x 8 weeks
The MTD is reached when two or more patients (out of 6) at a dose level experience DLT.
5 secondary outcomes
Response by Recist criteria
Time frame: Eight(8) weeks
Tumor response by resist criteria
Time frame: 8 weeks
Tumor response
Time frame: Eight weeks
Benefit
Time frame: Eight(8) weeks
Objective change in measurable tumor size by Resist criteria
Time frame: once after 8 weeky treatments
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2022.
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.
Richard Greil, MD principal investigator
Medicizinische Universitatsklinik Hematologie,Internistische Onkologie
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Liposomeal curcumin in people with Patients w/Advanced Cancer That Failed Std of Care Therapy, run by SignPath Pharma, Inc. at 2 sites in Austria.
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 10 inclusion and 8 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: finished, as of the sponsor's last update on 11 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Austria. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Dose limiting toxicity with focus on hemolysis (time frame: Eight(8) weeks). The study lists 4 primary outcomes in all. 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 11 May 2022.