Clinical trial · Interventional
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
NCT03607643CI-TRIAL-00034049unknownPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer, Gall Bladder | Malignant Neoplasm | ALIAS | 0.85 |
| Cancer of Colon | Malignant Colon Neoplasm | ALIAS | 0.90 |
| Cancer of Liver | Malignant Liver Neoplasm | ALIAS | 0.90 |
| Cancer of Pancreas | Malignant Pancreatic Neoplasm | ALIAS | 0.90 |
| Cancer of Rectum | Malignant Rectal Neoplasm | ALIAS | 0.90 |
| Glioblastoma Multiforme | Glioblastoma | CURATED_BROADER | 0.80 |
| Myeloma Multiple | Multiple Myeloma | ALIAS | 0.90 |
Interventions
Interventions (9)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-FU | Drug | Fluorouracil | ALIAS |
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| Bortezomib | Drug | Bortezomib | ALIAS |
| Cannabidiol | Drug | — | UNRESOLVED |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Irinotecan | Drug | Irinotecan | ALIAS |
| Leucovorin | Drug | Leucovorin | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
| Temozolomide | Drug |
Design
Arms and outcomes
Arms (10)
- type
- PLACEBO_COMPARATOR
- label
- Colon: Chemo + Placebo
- description
- 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.
- interventionNames
- Drug: Leucovorin
- Drug: 5-FU
- Drug: Oxaliplatin
- Drug: Bevacizumab
- Drug: Irinotecan
- type
- EXPERIMENTAL
- label
- Colon: Chemo + BRCX014
- description
- 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.
- interventionNames
- Drug: Cannabidiol
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.