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A Study of the Efficacy of Cannabidiol in Patients With Multiple Myeloma, Glioblastoma Multiforme, and GI Malignancies

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ClinicalTrials.gov Identifier: NCT03607643
Recruitment Status : Not yet recruiting
First Posted : July 31, 2018
Last Update Posted : July 31, 2018
Sponsor:
Information provided by (Responsible Party):
Leaf Vertical Inc.

Tracking Information
First Submitted Date  ICMJE June 5, 2018
First Posted Date  ICMJE July 31, 2018
Last Update Posted Date July 31, 2018
Estimated Study Start Date  ICMJE January 15, 2019
Estimated Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 22, 2018)
Response rate [ Time Frame: Through study completion, an average of one year ]
The primary objective of this study is to evaluate the overall response rates of cancer patients as assessed by standard criteria.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 22, 2018)
  • Time to progression (TTP) in patients using lab results and radiographic data. [ Time Frame: Through study completion, an average of one year ]
    A secondary objective of this study is to measure TTP using lab results and radiographic data.
  • Progression-free survival (PFS) in patients using lab results and radiographic data. [ Time Frame: Through study completion, an average of one year ]
    A secondary objective of this study is to measure PFS using lab results and radiographic data.
  • Quality-of-life assessment in patients using patient-reported outcomes (PRO) data. [ Time Frame: Through study completion, an average of one year ]
    A secondary objective of this study is to collect patient-reported outcomes (PRO) data.
  • Quality-of-life assessment in patients using clinician-reported outcomes (ClinRO) data. [ Time Frame: Through study completion, an average of one year ]
    A secondary objective of this study is to collect clinician-reported outcomes (ClinRO) data.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of the Efficacy of Cannabidiol in Patients With Multiple Myeloma, Glioblastoma Multiforme, and GI Malignancies
Official Title  ICMJE Randomized Double-Blind, Placebo-Controlled Parallel Multi-Center Study to Assess the Efficacy of Cannabidiol (BRCX014) Combined With Standard-Of-Care Treatment in Subjects With Multiple Myeloma, Glioblastoma Multiforme, and GI Malignancies
Brief Summary A Randomized, Double-Blind, Placebo-Controlled, Parallel, Multi-Center Study to Assess the Efficacy of BRCX014 Combined with Standard-Of-Care Treatment in Subjects with Glioblastoma Multiforme, Multiple Myeloma, and GI Malignancies
Detailed Description Several studies have shown a potential anti-tumor role for cannabinoids by modulating cell signaling pathways, inhibiting angiogenesis, inducing apoptosis, and overcoming chemotherapy resistance. In phase I trials, cannabinoids have been shown to enhance the uptake of chemotherapy into malignant cells without affecting normal cells. The investigators seeks to demonstrate that the combination of chemotherapy with BRCX014 will have a greater anti-tumor and anti-proliferative activity when compared to standard of care alone.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
Study length for randomized patients in the treatment group(s) will be 180 days. For those subjects randomized into the control group(s), after 90 days of the control group study treatment, will be given the choice to rollover into the treatment group. Crossover is also permitted if there is progression of disease before 90 days.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Participant, care provider, investigator, and outcomes assessor will be blinded to standard of care (SOC) alone vs treatment arm
Primary Purpose: Treatment
Condition  ICMJE
  • Cancer of Pancreas
  • Cancer of Liver
  • Cancer of Rectum
  • Cancer of Colon
  • Cancer, Gall Bladder
  • Myeloma Multiple
  • Glioblastoma Multiforme
Intervention  ICMJE
  • Drug: Cannabidiol
    • Sublingual dose of 1 mL (0.910 g) of BRCX014 in the morning, prior to the first meal of the day
    • Sublingual dose of 1 mL (0.910 g) of BRCX014 in the afternoon, prior to the evening meal
    Other Names:
    • BRCX014
    • bioRenovate CX
  • Drug: Bortezomib
    Standard of care (SOC) chemotherapy for multiple myeloma will include a bortezomib-based regimen given at 1.3 mg/m2 on days 1, 4, 8 & 11 schedule to be repeated every 21 days.
    Other Name: Velcade
  • Drug: Leucovorin
    Standard of care chemotherapy for Stage IV colon or rectal cancer, will include leucovorin 350 mg/m2 IV over 2 hours Day 1, 5-FU 400 mg/m2 IV bolus followed 2400 mg/m2 IV over 46 hours, oxaliplatin 100 mg/m2 IV Day 1, bevacizumab 5 mg/kg IV day1. Irinotecan can be substituted for oxaliplatin.
    Other Name: Folinic acid
  • Drug: 5-FU
    Standard of care chemotherapy for Stage IV colon or rectal cancer, will include leucovorin 350 mg/m2 IV over 2 hours Day 1, 5-FU 400 mg/m2 IV bolus followed 2400 mg/m2 IV over 46 hours, oxaliplatin 100 mg/m2 IV Day 1, bevacizumab 5 mg/kg IV day1. Irinotecan can be substituted for oxaliplatin.
    Other Name: Efudex
  • Drug: Oxaliplatin
    Standard of care chemotherapy for Stage IV colon or rectal cancer, will include leucovorin 350 mg/m2 IV over 2 hours Day 1, 5-FU 400 mg/m2 IV bolus followed 2400 mg/m2 IV over 46 hours, oxaliplatin 100 mg/m2 IV Day 1, bevacizumab 5 mg/kg IV day1. Irinotecan can be substituted for oxaliplatin.
    Other Name: Eloxatin
  • Drug: Bevacizumab
    Standard of care chemotherapy for Stage IV colon or rectal cancer, will include leucovorin 350 mg/m2 IV over 2 hours Day 1, 5-FU 400 mg/m2 IV bolus followed 2400 mg/m2 IV over 46 hours, oxaliplatin 100 mg/m2 IV Day 1, bevacizumab 5 mg/kg IV day1. Irinotecan can be substituted for oxaliplatin.
    Other Name: Avastin
  • Drug: Irinotecan
    Standard of care chemotherapy for Stage IV colon or rectal cancer, will include leucovorin 350 mg/m2 IV over 2 hours Day 1, 5-FU 400 mg/m2 IV bolus followed 2400 mg/m2 IV over 46 hours, oxaliplatin 100 mg/m2 IV Day 1, bevacizumab 5 mg/kg IV day1. Irinotecan can be substituted for oxaliplatin.
    Other Name: Camptosar
  • Drug: Gemcitabine
    Stage IV pancreatic cancer will include a gemcitabine-based regiment at 1000 mg/m2 day 1, 7, 15 of a 21-day cycle.
    Other Name: Gemzar
  • Drug: Temozolomide
    Standard of care chemotherapy for patients with glioblastoma multiforme includes concurrent radiation therapy (2 Gy per day for a total of 60 Gy) and temozolomide (75 mg per square meter of body-surface area per day, 7 days per week from the first to the last day of radiotherapy), followed by six cycles of adjuvant temozolomide (150 to 200 mg per square meter for 5 days during each 28-day cycle).
    Other Name: Temodar
Study Arms  ICMJE
  • Placebo Comparator: Colon: Chemo + Placebo
    Standard of care chemotherapy for Stage IV colon or rectal cancer, will include leucovorin 350 mg/m2 IV over 2 hours Day 1, 5-FU 400 mg/m2 IV bolus followed 2400 mg/m2 IV over 46 hours, oxaliplatin 100 mg/m2 IV Day 1, bevacizumab 5 mg/kg IV day1. Irinotecan can be substituted for oxaliplatin.
    Interventions:
    • Drug: Leucovorin
    • Drug: 5-FU
    • Drug: Oxaliplatin
    • Drug: Bevacizumab
    • Drug: Irinotecan
  • Experimental: Colon: Chemo + BRCX014
    Cannabidiol (BRCX014) 200 mg daily plus Standard of care chemotherapy for Stage IV colon or rectal cancer, will include leucovorin 350 mg/m2 IV over 2 hours Day 1, 5-FU 400 mg/m2 IV bolus followed 2400 mg/m2 IV over 46 hours, oxaliplatin 100 mg/m2 IV Day 1, bevacizumab 5 mg/kg IV day1. Irinotecan can be substituted for oxaliplatin.
    Interventions:
    • Drug: Cannabidiol
    • Drug: Leucovorin
    • Drug: 5-FU
    • Drug: Oxaliplatin
    • Drug: Bevacizumab
    • Drug: Irinotecan
  • Placebo Comparator: Rectal: Chemo + Placebo
    Standard of care chemotherapy for Stage IV colon or rectal cancer, will include leucovorin 350 mg/m2 IV over 2 hours Day 1, 5-FU 400 mg/m2 IV bolus followed 2400 mg/m2 IV over 46 hours, oxaliplatin 100 mg/m2 IV Day 1, bevacizumab 5 mg/kg IV day1. Irinotecan can be substituted for oxaliplatin.
    Interventions:
    • Drug: Leucovorin
    • Drug: 5-FU
    • Drug: Oxaliplatin
    • Drug: Bevacizumab
    • Drug: Irinotecan
  • Experimental: Rectal: Chemo + BRCX014
    Cannabidiol (BRCX014) 200 mg daily plus Standard of care chemotherapy for Stage IV colon or rectal cancer, will include leucovorin 350 mg/m2 IV over 2 hours Day 1, 5-FU 400 mg/m2 IV bolus followed 2400 mg/m2 IV over 46 hours, oxaliplatin 100 mg/m2 IV Day 1, bevacizumab 5 mg/kg IV day1. Irinotecan can be substituted for oxaliplatin.
    Interventions:
    • Drug: Cannabidiol
    • Drug: Leucovorin
    • Drug: 5-FU
    • Drug: Oxaliplatin
    • Drug: Bevacizumab
    • Drug: Irinotecan
  • Placebo Comparator: Multiple myeloma: Chemo + Placebo
    Standard of care (SOC) chemotherapy for multiple myeloma will include a bortezomib-based regimen given at 1.3 mg/m2 on days 1, 4, 8 & 11 schedule to be repeated every 21 days.
    Intervention: Drug: Bortezomib
  • Experimental: Multiple myeloma: Chemo + BRCX014
    Cannabidiol (BRCX014) 200 mg daily plus Standard of care (SOC) chemotherapy for multiple myeloma will include a bortezomib-based regimen given at 1.3 mg/m2 on days 1, 4, 8 & 11 schedule to be repeated every 21 days.
    Interventions:
    • Drug: Cannabidiol
    • Drug: Bortezomib
  • Placebo Comparator: Pancreatic: Chemo + Placebo
    Stage IV pancreatic cancer will include a gemcitabine-based regiment at 1000 mg/m2 day 1, 7, 15 of a 21-day cycle.
    Intervention: Drug: Gemcitabine
  • Experimental: Pancreatic: Chemo + BRCX014
    Cannabidiol (BRCX014) 200 mg daily plus Stage IV pancreatic cancer will include a gemcitabine-based regiment at 1000 mg/m2 day 1, 7, 15 of a 21-day cycle.
    Interventions:
    • Drug: Cannabidiol
    • Drug: Gemcitabine
  • Placebo Comparator: GBM: Chemo + Placebo
    Standard of care chemotherapy for patients with glioblastoma multiforme includes concurrent radiation therapy (2 Gy per day for a total of 60 Gy) and temozolomide (75 mg per square meter of body-surface area per day, 7 days per week from the first to the last day of radiotherapy), followed by six cycles of adjuvant temozolomide (150 to 200 mg per square meter for 5 days during each 28-day cycle).
    Intervention: Drug: Temozolomide
  • Experimental: GBM: Chemo + BRCX014
    Cannabidiol (BRCX014) 200 mg daily plus Standard of care chemotherapy for patients with glioblastoma multiforme includes concurrent radiation therapy (2 Gy per day for a total of 60 Gy) and temozolomide (75 mg per square meter of body-surface area per day, 7 days per week from the first to the last day of radiotherapy), followed by six cycles of adjuvant temozolomide (150 to 200 mg per square meter for 5 days during each 28-day cycle).
    Interventions:
    • Drug: Cannabidiol
    • Drug: Temozolomide
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 Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 22, 2018)
160
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 15, 2020
Estimated Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Signed and dated informed consent
  2. Male and Females age 18 to 80 years old at the time of screening
  3. Confirmed tissue diagnosis of Multiple myeloma, GI malignancy by a licensed pathologist
  4. A performance status 0-1 on the Eastern Cooperative Oncology Group (ECOG) scale.
  5. Females of childbearing potential willing to utilize two approved forms of contraceptives (e.g., birth control, abstinence, spermicidal lube, intrauterine device [IUD])
  6. Male study subjects must be willing to use two approved forms of contraceptives (e.g., physical barrier-condoms, abstinence, spermicidal lube)

Exclusion Criteria:

  1. Subject is pregnant or plans to become pregnant or actively lactating/nursing
  2. Hypersensitivity to any ingredient in the study product
  3. Initial laboratory values as determined by the principal investigator to be clinically significant
  4. A substance abuse history within the last five years
  5. Any diseases or conditions that may interfere with the conduct of the study or interpretation of the study results
  6. .Close affiliation with the investigational site (e.g., a close relative of the investigator), dependent person (employee or student of investigational site, or sponsor's staff)
  7. Currently enrolled in another investigational clinical study
  8. A known history of severe depression or psychiatric disorders or active suicidal ideation
  9. Inability or unwillingness to cooperate with the study procedures for any reasons
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Philip Arlen, PhD 407-443-0656 parlen@leafvertical.com
Contact: William Fisher 407-797-2332 ceo@leafvertical.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03607643
Other Study ID Numbers  ICMJE Olympian
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Leaf Vertical Inc.
Study Sponsor  ICMJE Leaf Vertical Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sarah F Katta, DO Leaf Vertical Inc.
PRS Account Leaf Vertical Inc.
Verification Date July 2018

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