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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.

Tracking Information
First Submitted Date  ICMJE May 14, 2014
First Posted Date  ICMJE May 15, 2014
Last Update Posted Date May 9, 2017
Study Start Date  ICMJE March 2014
Estimated Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 15, 2014)
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 14, 2014)
  • 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.
  • Deternmine 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 ]
Change History Complete list of historical versions of study NCT02138955 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 14, 2014)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 14, 2014)
Serologic changes in hepatic, renal, cardiac parameters [ Time Frame: weekly x 8 weeks ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Phase IB Dose Escalation Study of Lipocurc in Patients With Cancer
Official Title  ICMJE : A PHASE Ib DOSE ESCALATION STUDY ON THE SAFETY, TOLERABILITY AND ACTIVITY OF LIPOSOMAL CURCUMIN IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC CANCER
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Patients With Advanced Cancer Who Have Failed Standard of Care Therapy
Intervention  ICMJE Drug: Liposomeal curcumin
Study Arms  ICMJE Experimental: Liposomeal curcumin ascending dose phase 1b
Intervention: Drug: Liposomeal curcumin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 15, 2016)
33
Original Estimated Enrollment  ICMJE
 (submitted: May 14, 2014)
28
Estimated Study Completion Date  ICMJE June 30, 2017
Estimated Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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%.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02138955
Other Study ID Numbers  ICMJE Lipocurc1002/P-1-010
0011594-24
SPP1002 ( Other Identifier: SignPath Pharma,Inc )
2013-001594-24 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party SignPath Pharma, Inc.
Study Sponsor  ICMJE SignPath Pharma, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Richard Greil, MD Medicizinische Universitatsklinik Hematologie,Internistische Onkologie
PRS Account SignPath Pharma, Inc.
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP