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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
Sponsor:
Information provided by (Responsible Party):
SignPath Pharma, Inc.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Patients With Advanced Cancer Who Have Failed Standard of Care Therapy Drug: Liposomeal curcumin Phase 1 Phase 2

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
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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

Resource links provided by the National Library of Medicine

Drug Information available for: Curcumin

Arms and Interventions
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Arm Intervention/treatment
Experimental: Liposomeal curcumin ascending dose phase 1b Drug: Liposomeal curcumin


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. Maximum tolerated dose defined by < Grade 1 hematologic toxicity, [ Time Frame: Outcome measured weekly x 8 weeks ]

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Objective change in measurable tumor size by Resist criteria [ Time Frame: once after 8 weeky treatments ]

Other Outcome Measures:
  1. Serologic changes in hepatic, renal, cardiac parameters [ Time Frame: weekly x 8 weeks ]

Eligibility Criteria
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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
Criteria

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%.
Contacts and Locations
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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


Locations
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Austria
3 Medicizinische Universitatsklinik Hematologie,Internistische Onkologie
Salzburg, Austria, 5020
3. Medizinische Universitatesclinik, Haematologie, Internistische Onkologie
Salzburg, Austria, 5020
Sponsors and Collaborators
SignPath Pharma, Inc.
Investigators
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Principal Investigator: Richard Greil, MD Medicizinische Universitatsklinik Hematologie,Internistische Onkologie
More Information
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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
Additional relevant MeSH terms:
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Curcumin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action