Clinical Trial: NCT03607643 - My Cancer Genome

NCT03607643

Description:

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

Related Conditions:

Colorectal Carcinoma
Conventional Glioblastoma Multiforme
Multiple Myeloma
Pancreatic Carcinoma

Recruiting Status:

Unknown status

Phase:

Phase 1/Phase 2

URL:

https://clinicaltrials.gov/show/NCT03607643

Trial Eligibility

Document

Title

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

Clinical Trial IDs

ORG STUDY ID: Olympian
NCT ID: NCT03607643

Conditions

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

Interventions

Drug	Synonyms	Arms
Cannabidiol	BRCX014, bioRenovate CX	Colon: Chemo + BRCX014
Bortezomib	Velcade	Multiple myeloma: Chemo + BRCX014
Leucovorin	Folinic acid	Colon: Chemo + BRCX014
5-FU	Efudex	Colon: Chemo + BRCX014
Oxaliplatin	Eloxatin	Colon: Chemo + BRCX014
Bevacizumab	Avastin	Colon: Chemo + BRCX014
Irinotecan	Camptosar	Colon: Chemo + BRCX014
Gemcitabine	Gemzar	Pancreatic: Chemo + BRCX014
Temozolomide	Temodar	GBM: Chemo + BRCX014

Purpose

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.

Trial Arms

Name	Type	Description	Interventions
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.	Leucovorin 5-FU Oxaliplatin Bevacizumab 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.	Cannabidiol Leucovorin 5-FU Oxaliplatin Bevacizumab 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.	Leucovorin 5-FU Oxaliplatin Bevacizumab 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.	Cannabidiol Leucovorin 5-FU Oxaliplatin Bevacizumab 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.	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.	Cannabidiol 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.	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.	Cannabidiol 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).	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).	Cannabidiol Temozolomide

Eligibility 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

Maximum Eligible Age:	80 Years
Minimum Eligible Age:	18 Years
Eligible Gender:	All
Healthy Volunteers:	No

Primary Outcome Measures

Measure:	Response rate
Time Frame:	Through study completion, an average of one year
Safety Issue:
Description:	The primary objective of this study is to evaluate the overall response rates of cancer patients as assessed by standard criteria.

Secondary Outcome Measures

Measure:	Time to progression (TTP) in patients using lab results and radiographic data.
Time Frame:	Through study completion, an average of one year
Safety Issue:
Description:	A secondary objective of this study is to measure TTP using lab results and radiographic data.

Measure:	Progression-free survival (PFS) in patients using lab results and radiographic data.
Time Frame:	Through study completion, an average of one year
Safety Issue:
Description:	A secondary objective of this study is to measure PFS using lab results and radiographic data.

Measure:	Quality-of-life assessment in patients using patient-reported outcomes (PRO) data.
Time Frame:	Through study completion, an average of one year
Safety Issue:
Description:	A secondary objective of this study is to collect patient-reported outcomes (PRO) data.

Measure:	Quality-of-life assessment in patients using clinician-reported outcomes (ClinRO) data.
Time Frame:	Through study completion, an average of one year
Safety Issue:
Description:	A secondary objective of this study is to collect clinician-reported outcomes (ClinRO) data.

Details

Phase:	Phase 1/Phase 2
Primary Purpose:	Interventional
Overall Status:	Unknown status
Lead Sponsor:	Leaf Vertical Inc.

Last Updated

July 31, 2018

Clinical Trials /

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