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

NCT02138955 | Completed Phase 1 DMC

• 4 other identifiers: Lipocurc1002/P-1-0100011594-24SPP10022013-001594-24
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Patients w/Advanced Cancer That Failed Std of Care Therapy

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  Outcome measured weekly x 8 weeks

Secondary Outcomes (5)

• Response by Recist criteria

  Eight(8) weeks

• Tumor response by resist criteria

  8 weeks

• Tumor response

  Eight weeks

• Benefit

  Eight(8) weeks

• Objective change in measurable tumor size by Resist criteria

  once after 8 weeky treatments

Other Outcomes (1)

• Serologic changes in hepatic, renal, cardiac parameters

  weekly x 8 weeks

Study Arms (1)

Liposomeal curcumin ascending dose phase 1b

EXPERIMENTAL

Drug: Liposomeal curcumin

Interventions

Liposomeal curcumin DRUG

Liposomeal curcumin ascending dose phase 1b

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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%.

Sponsors & Collaborators

• SignPath Pharma, Inc.: lead

Study Sites (2)

3 Medicizinische Universitatsklinik Hematologie,Internistische Onkologie

Salzburg, 5020, Austria

Location

3. Medizinische Universitatesclinik, Haematologie, Internistische Onkologie

Salzburg, 5020, Austria

Location

Study Officials

• Richard Greil, MD

  Medicizinische Universitatsklinik Hematologie,Internistische Onkologie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2014
• First Posted: May 15, 2014
• Study Start: March 1, 2014
• Primary Completion: November 30, 2017
• Study Completion: February 15, 2018
• Last Updated: May 11, 2022

Record last verified: 2017-05

Locations

AU (2)