A Phase IB Dose Escalation Study of Lipocurc in Patients With Cancer

• ClinicalTrials.gov Identifier: NCT02138955
• Recruitment Status: Unknown
• First Posted: May 15, 2014
• Last Update Posted: May 9, 2017
• Sponsor: SignPath Pharma, Inc.
• Information provided by (Responsible Party): SignPath Pharma, Inc.

Tracking Information

• First Submitted Date: May 14, 2014
• First Posted Date: May 15, 2014
• Last Update Posted Date: May 9, 2017
• Study Start Date: March 2014
• Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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 ]

Current Secondary Outcome Measures (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: 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: A Phase IB Dose Escalation Study of Lipocurc in Patients With Cancer
• 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
• 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: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Patients With Advanced Cancer Who Have Failed Standard of Care Therapy
• Intervention: Drug: Liposomeal curcumin

Study Arms

Experimental: Liposomeal curcumin ascending dose phase 1b

Intervention: Drug: Liposomeal curcumin

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: October 15, 2016): 33
• Original Estimated Enrollment (submitted: May 14, 2014): 28
• Estimated Study Completion Date: June 30, 2017
• Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)

Eligibility 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%.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 85 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Austria

Administrative Information

• NCT Number: NCT02138955
• Other Study ID Numbers: 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: Not Provided
• Responsible Party: SignPath Pharma, Inc.
• Study Sponsor: SignPath Pharma, Inc.
• Collaborators: Not Provided

Investigators

• Principal Investigator: Richard Greil, MD; Medicizinische Universitatsklinik Hematologie,Internistische Onkologie

• PRS Account: SignPath Pharma, Inc.
• Verification Date: May 2017