A Phase IB Dose Escalation Study of Lipocurc in Patients With Cancer
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ClinicalTrials.gov Identifier: NCT02138955 |
Recruitment Status : Unknown
Verified May 2017 by SignPath Pharma, Inc..
Recruitment status was: Active, not recruiting
First Posted : May 15, 2014
Last Update Posted : May 9, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Patients With Advanced Cancer Who Have Failed Standard of Care Therapy | Drug: Liposomeal curcumin | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 33 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | March 2014 |
Estimated Primary Completion Date : | June 2017 |
Estimated Study Completion Date : | June 30, 2017 |

Arm | Intervention/treatment |
---|---|
Experimental: Liposomeal curcumin ascending dose phase 1b |
Drug: Liposomeal curcumin |
- Safety [ 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 ]
- Response by Recist criteria [ Time Frame: Eight(8) weeks ]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.
- Tumor response by resist criteria [ Time Frame: 8 weeks ]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.
- Tumor response [ Time Frame: Eight weeks ]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.
- Benefit [ Time Frame: Eight(8) weeks ]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.
- Objective change in measurable tumor size by Resist criteria [ Time Frame: once after 8 weeky treatments ]
- Serologic changes in hepatic, renal, cardiac parameters [ Time Frame: weekly x 8 weeks ]

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Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
- 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.
Exclusion Criteria:
- 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%.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02138955
Austria | |
3 Medicizinische Universitatsklinik Hematologie,Internistische Onkologie | |
Salzburg, Austria, 5020 | |
3. Medizinische Universitatesclinik, Haematologie, Internistische Onkologie | |
Salzburg, Austria, 5020 |
Principal Investigator: | Richard Greil, MD | Medicizinische Universitatsklinik Hematologie,Internistische Onkologie |
Responsible Party: | SignPath Pharma, Inc. |
ClinicalTrials.gov Identifier: | NCT02138955 |
Other Study ID Numbers: |
Lipocurc1002/P-1-010 0011594-24 SPP1002 ( Other Identifier: SignPath Pharma,Inc ) 2013-001594-24 ( EudraCT Number ) |
First Posted: | May 15, 2014 Key Record Dates |
Last Update Posted: | May 9, 2017 |
Last Verified: | May 2017 |
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