Overview

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

Status:
Unknown status
Trial end date:
2020-12-15
Target enrollment:
0
Participant gender:
All
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
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Leaf Vertical Inc.
Treatments:
Bevacizumab
Bortezomib
Camptothecin
Cannabidiol
Dacarbazine
Gemcitabine
Irinotecan
Leucovorin
Oxaliplatin
Temozolomide
Criteria
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