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Cannabinoid

Rectal: Chemo + BRCX014 for Gallbladder Cancer

Phase 1 & 2

Waitlist Available

Led By Sarah F Katta, DO

Research Sponsored by Leaf Vertical Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of one year

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

Summary

This trial tests a new drug, BRCX014, combined with standard treatments for patients with certain hard-to-treat cancers. The drug aims to make chemotherapy more effective by targeting cancer cells without affecting normal cells.

Eligible Conditions

Rectal Cancer
Colon Cancer
Gallbladder Cancer
Multiple Myeloma
Liver Cancer
Glioblastoma
Pancreatic Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of one year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of one year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of one year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Response rate

Secondary study objectives

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

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

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

+1 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

Trial Design

10Treatment groups

Experimental Treatment

Placebo Group

Group I: Rectal: Chemo + BRCX014Experimental Treatment6 Interventions

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.

Group II: Pancreatic: Chemo + BRCX014Experimental Treatment2 Interventions

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.

Group III: Multiple myeloma: Chemo + BRCX014Experimental Treatment2 Interventions

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.

Group IV: GBM: Chemo + BRCX014Experimental Treatment2 Interventions

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).

Group V: Colon: Chemo + BRCX014Experimental Treatment6 Interventions

Group VI: Pancreatic: Chemo + PlaceboPlacebo Group1 Intervention

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

Group VII: GBM: Chemo + PlaceboPlacebo Group1 Intervention

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).

Group VIII: Rectal: Chemo + PlaceboPlacebo Group5 Interventions

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.

Group IX: Colon: Chemo + PlaceboPlacebo Group5 Interventions

Group X: Multiple myeloma: Chemo + PlaceboPlacebo Group1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Irinotecan

FDA approved

Temozolomide

FDA approved

Cannabidiol

FDA approved

Fluorouracil

FDA approved