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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.

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.

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.

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.

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

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.

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).

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).

* 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

5-FU

Philip Arlen, PhD

William Fisher

Sarah Katta, DO

Sarah F Katta, DO

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

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 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.

Participant, care provider, investigator, and outcomes assessor will be blinded to standard of care (SOC) alone vs treatment arm

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

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

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

A secondary objective of this study is to measure TTP using lab results and radiographic data.

A secondary objective of this study is to measure PFS using lab results and radiographic data.

A secondary objective of this study is to collect patient-reported outcomes (PRO) data.

A secondary objective of this study is to collect clinician-reported outcomes (ClinRO) data.

Leaf Vertical Inc.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of the Efficacy of Cannabidiol in Patients With Multiple Myeloma, Glioblastoma Multiforme, and GI Malignancies	NCT03607643	Cancer of Pancr... Cancer of Liver Cancer of Rectu... Cancer of Colon Cancer, Gall Bl... Myeloma Multipl... Glioblastoma Mu...	Cannabidiol Bortezomib Leucovorin 5-FU Oxaliplatin Bevacizumab Irinotecan Gemcitabine Temozolomide	18 Years - 80 Years	Leaf Vertical Inc.
A Study of the Efficacy of Cannabidiol in Patients With Multiple Myeloma, Glioblastoma Multiforme, and GI Malignancies	NCT03607643	Cancer of Pancr... Cancer of Liver Cancer of Rectu... Cancer of Colon Cancer, Gall Bl... Myeloma Multipl... Glioblastoma Mu...	Cannabidiol Bortezomib Leucovorin 5-FU Oxaliplatin Bevacizumab Irinotecan Gemcitabine Temozolomide	18 Years - 80 Years	Leaf Vertical Inc.

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