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

NCT03607643 | Unknown Phase 1 DMC FDA Drug

• 1 other identifier: Olympian
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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

Conditions

Cancer of Pancreas; Cancer of Liver; Cancer of Rectum; Cancer of Colon; Cancer, Gall Bladder; Myeloma Multiple; Glioblastoma Multiforme

Outcome Measures

Primary Outcomes (1)

• Response rate

  The primary objective of this study is to evaluate the overall response rates of cancer patients as assessed by standard criteria.

  Through study completion, an average of one year

Secondary Outcomes (4)

• Time to progression (TTP) in patients using lab results and radiographic data.

  Through study completion, an average of one year

• Progression-free survival (PFS) in patients using lab results and radiographic data.

  Through study completion, an average of one year

• Quality-of-life assessment in patients using patient-reported outcomes (PRO) data.

  Through study completion, an average of one year

• Quality-of-life assessment in patients using clinician-reported outcomes (ClinRO) data.

  Through study completion, an average of one year

Study Arms (10)

Colon: Chemo + Placebo

PLACEBO COMPARATOR

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.

Drug: Leucovorin; Drug: 5-FU; Drug: Oxaliplatin; Drug: Bevacizumab; Drug: Irinotecan

Colon: Chemo + BRCX014

EXPERIMENTAL

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.

Drug: Cannabidiol; Drug: Leucovorin; Drug: 5-FU; Drug: Oxaliplatin; Drug: Bevacizumab; Drug: Irinotecan

Rectal: Chemo + Placebo

PLACEBO COMPARATOR

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.

Drug: Leucovorin; Drug: 5-FU; Drug: Oxaliplatin; Drug: Bevacizumab; Drug: Irinotecan

Rectal: Chemo + BRCX014

EXPERIMENTAL

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.

Drug: Cannabidiol; Drug: Leucovorin; Drug: 5-FU; Drug: Oxaliplatin; Drug: Bevacizumab; Drug: Irinotecan

Multiple myeloma: Chemo + Placebo

PLACEBO COMPARATOR

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.

Drug: Bortezomib

Multiple myeloma: Chemo + BRCX014

EXPERIMENTAL

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.

Drug: Cannabidiol; Drug: Bortezomib

Pancreatic: Chemo + Placebo

PLACEBO COMPARATOR

Stage IV pancreatic cancer will include a gemcitabine-based regiment at 1000 mg/m2 day 1, 7, 15 of a 21-day cycle.

Drug: Gemcitabine

Pancreatic: Chemo + BRCX014

EXPERIMENTAL

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.

Drug: Cannabidiol; Drug: Gemcitabine

GBM: Chemo + Placebo

PLACEBO COMPARATOR

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).

Drug: Temozolomide

GBM: Chemo + BRCX014

EXPERIMENTAL

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).

Drug: Cannabidiol; Drug: Temozolomide

Interventions

Cannabidiol DRUG

* 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

Also known as: BRCX014, bioRenovate CX

Colon: Chemo + BRCX014; GBM: Chemo + BRCX014; Multiple myeloma: Chemo + BRCX014; Pancreatic: Chemo + BRCX014; Rectal: Chemo + BRCX014

Bortezomib DRUG

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.

Also known as: Velcade

Multiple myeloma: Chemo + BRCX014; Multiple myeloma: Chemo + Placebo

Leucovorin DRUG

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.

Also known as: Folinic acid

Colon: Chemo + BRCX014; Colon: Chemo + Placebo; Rectal: Chemo + BRCX014; Rectal: Chemo + Placebo

5-FU DRUG

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.

Also known as: Efudex

Colon: Chemo + BRCX014; Colon: Chemo + Placebo; Rectal: Chemo + BRCX014; Rectal: Chemo + Placebo

Oxaliplatin DRUG

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.

Also known as: Eloxatin

Colon: Chemo + BRCX014; Colon: Chemo + Placebo; Rectal: Chemo + BRCX014; Rectal: Chemo + Placebo

Bevacizumab DRUG

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.

Also known as: Avastin

Colon: Chemo + BRCX014; Colon: Chemo + Placebo; Rectal: Chemo + BRCX014; Rectal: Chemo + Placebo

Irinotecan DRUG

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.

Also known as: Camptosar

Colon: Chemo + BRCX014; Colon: Chemo + Placebo; Rectal: Chemo + BRCX014; Rectal: Chemo + Placebo

Gemcitabine DRUG

Stage IV pancreatic cancer will include a gemcitabine-based regiment at 1000 mg/m2 day 1, 7, 15 of a 21-day cycle.

Also known as: Gemzar

Pancreatic: Chemo + BRCX014; Pancreatic: Chemo + Placebo

Temozolomide DRUG

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).

Also known as: Temodar

GBM: Chemo + BRCX014; GBM: Chemo + Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Subject is pregnant or plans to become pregnant or actively lactating/nursing
• Hypersensitivity to any ingredient in the study product
• Initial laboratory values as determined by the principal investigator to be clinically significant
• A substance abuse history within the last five years
• Any diseases or conditions that may interfere with the conduct of the study or interpretation of the study results
• 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)
• Currently enrolled in another investigational clinical study
• A known history of severe depression or psychiatric disorders or active suicidal ideation
• Inability or unwillingness to cooperate with the study procedures for any reasons

Sponsors & Collaborators

• Leaf Vertical Inc.: lead

Study Sites (1)

Southwest Cancer Center

Orlando, Florida, 32806, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Liver Neoplasms; Rectal Neoplasms; Colonic Neoplasms; Gallbladder Neoplasms; Multiple Myeloma; Glioblastoma

Interventions

Cannabidiol; Bortezomib; Leucovorin; Fluorouracil; Oxaliplatin; Bevacizumab; Irinotecan; Gemcitabine; Temozolomide

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Liver Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Colonic Diseases; Biliary Tract Neoplasms; Biliary Tract Diseases; Gallbladder Diseases; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals; Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Uracil; Pyrimidinones; Pyrimidines; Coordination Complexes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Camptothecin; Alkaloids; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Dacarbazine; Triazenes; Imidazoles; Azoles

Study Officials

• Sarah F Katta, DO

  Leaf Vertical Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Philip Arlen, PhD

CONTACT

407-443-0656; parlen@leafvertical.com

William Fisher

CONTACT

407-797-2332; ceo@leafvertical.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participant, care provider, investigator, and outcomes assessor will be blinded to standard of care (SOC) alone vs treatment arm
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 5, 2018
• First Posted: July 31, 2018
• Study Start: January 15, 2019
• Primary Completion: June 30, 2020
• Study Completion: December 15, 2020
• Last Updated: July 31, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)