Cancer of PancreasPhase 1/2NCT03607643
A Study of the Efficacy of Cannabidiol in Patients With Multiple Myeloma, Glioblastoma Multiforme, and GI Malignancies
A Phase 1/2 study testing Cannabidiol, Bortezomib and Leucovorin in people with Cancer of Pancreas and Cancer of Liver, run by Leaf Vertical Inc. at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cancer of Pancreas, Cancer of Liver, Cancer of Rectum
- What is being tested?
- Cannabidiol, Bortezomib and Leucovorin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2019to 15 Dec 2020
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed and dated informed consent
- Male and Females age 18 to 80 years old at the time of screening
- Confirmed tissue diagnosis of Multiple myeloma, GI malignancy by a licensed pathologist
- A performance status 0-1 on the Eastern Cooperative Oncology Group (ECOG) scale.
- Females of childbearing potential willing to utilize two approved forms of contraceptives (e.g., birth control, abstinence, spermicidal lube, intrauterine device [IUD])
- Male study subjects must be willing to use two approved forms of contraceptives (e.g., physical barrier-condoms, abstinence, spermicidal lube)
Who cannot join
- Subject is pregnant or plans to become pregnant or actively lactating/nursing
- Hypersensitivity to any ingredient in the study product
- Initial laboratory values as determined by the principal investigator to be clinically significant
- A substance abuse history within the last five years
- Any diseases or conditions that may interfere with the conduct of the study or interpretation of the study results
- .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)
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- Currently enrolled in another investigational clinical study
- A known history of severe depression or psychiatric disorders or active suicidal ideation
- Inability or unwillingness to cooperate with the study procedures for any reasons
Trial locations and contacts
1 site in 1 country.
United States1 site
Southwest Cancer Center
Orlando, Florida, 32806
Sarah Katta, DO, 407-426-8660, sarahfk1978@yahoo.com
Philip Arlen, PhD, 407-443-0656, parlen@leafvertical.com
About this study
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
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
Read the 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.
- Conditions
- Cancer of Pancreas, Cancer of Liver, Cancer of Rectum, Cancer of Colon, Cancer, Gall Bladder, Myeloma Multiple
- Being tested
- Cannabidiol, Bortezomib, Leucovorin, 5-FU, Oxaliplatin
- Medical subject headings
- Pancreatic Neoplasms, Liver Neoplasms, Rectal Neoplasms, Colonic Neoplasms, Gallbladder Neoplasms, Multiple Myeloma, Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CannabidiolDrug
Also called BRCX014, bioRenovate CX
- 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
BortezomibDrug
Also called Velcade
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.
LeucovorinDrug
Also called Folinic acid
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.
5-FUDrug
Also called Efudex
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.
OxaliplatinDrug
Also called Eloxatin
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.
BevacizumabDrug
Also called Avastin
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.
IrinotecanDrug
Also called Camptosar
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.
GemcitabineDrug
Also called Gemzar
Stage IV pancreatic cancer will include a gemcitabine-based regiment at 1000 mg/m2 day 1, 7, 15 of a 21-day cycle.
TemozolomideDrug
Also called Temodar
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Leucovorin; Drug: 5-FU; Drug: Oxaliplatin; Drug: Bevacizumab; Drug: 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. Receives: Drug: Cannabidiol; Drug: Leucovorin; Drug: 5-FU; Drug: Oxaliplatin; Drug: Bevacizumab; Drug: 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. Receives: Drug: Leucovorin; Drug: 5-FU; Drug: Oxaliplatin; Drug: Bevacizumab; Drug: 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. Receives: Drug: Cannabidiol; Drug: Leucovorin; Drug: 5-FU; Drug: Oxaliplatin; Drug: Bevacizumab; Drug: 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. Receives: Drug: 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. Receives: Drug: Cannabidiol; Drug: 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. Receives: Drug: 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. Receives: Drug: Cannabidiol; Drug: 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). Receives: Drug: 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). Receives: Drug: Cannabidiol; Drug: Temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
The primary objective of this study is to evaluate the overall response rates of cancer patients as assessed by standard criteria.
Measured: Through study completion, an average of one year
Secondary outcomes (4)
Time to progression (TTP) in patients using lab results and radiographic data.
A secondary objective of this study is to measure TTP using lab results and radiographic data.
Measured: Through study completion, an average of one year
Progression-free survival (PFS) in patients using lab results and radiographic data.
A secondary objective of this study is to measure PFS using lab results and radiographic data.
Measured: Through study completion, an average of one year
Quality-of-life assessment in patients using patient-reported outcomes (PRO) data.
A secondary objective of this study is to collect patient-reported outcomes (PRO) data.
Measured: Through study completion, an average of one year
Quality-of-life assessment in patients using clinician-reported outcomes (ClinRO) data.
A secondary objective of this study is to collect clinician-reported outcomes (ClinRO) data.
Measured: Through study completion, an average of one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2018
- Study start15 Jan 2019 (estimated)
- Primary completion30 Jun 2020 (estimated)
- Study completion15 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of PancreasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leaf Vertical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sarah F Katta, DO, Principal investigator, Leaf Vertical Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03607643
- Sponsor's protocol ID
- Olympian
- Status last verified
- Jul 2018
- First submitted
- 5 Jun 2018
- Last updated
- 31 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03607643
- Acronym / sponsor ID
- Olympian
- Conditions
- Cancer of Pancreas, Cancer of Liver, Cancer of Rectum, Cancer of Colon, Cancer, Gall Bladder, Myeloma Multiple
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Leaf Vertical Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Jan 2019 (estimated)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 15 Dec 2020 (estimated)
- First posted
- 31 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 10
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Colon: Chemo + Placebo | Placebo comparator | Drug: Leucovorin, Drug: 5-FU, Drug: Oxaliplatin, Drug: Bevacizumab, Drug: IrinotecanStandard 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. |
| Colon: Chemo + BRCX014 | Experimental | Drug: Cannabidiol, Drug: Leucovorin, Drug: 5-FU, Drug: Oxaliplatin, Drug: Bevacizumab, Drug: IrinotecanCannabidiol (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. |
| Rectal: Chemo + Placebo | Placebo comparator | Drug: Leucovorin, Drug: 5-FU, Drug: Oxaliplatin, Drug: Bevacizumab, Drug: IrinotecanStandard 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. |
| Rectal: Chemo + BRCX014 | Experimental | Drug: Cannabidiol, Drug: Leucovorin, Drug: 5-FU, Drug: Oxaliplatin, Drug: Bevacizumab, Drug: IrinotecanCannabidiol (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. |
| Multiple myeloma: Chemo + Placebo | Placebo comparator | Drug: BortezomibStandard 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. |
| Multiple myeloma: Chemo + BRCX014 | Experimental | Drug: Cannabidiol, Drug: BortezomibCannabidiol (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. |
| Pancreatic: Chemo + Placebo | Placebo comparator | Drug: GemcitabineStage IV pancreatic cancer will include a gemcitabine-based regiment at 1000 mg/m2 day 1, 7, 15 of a 21-day cycle. |
| Pancreatic: Chemo + BRCX014 | Experimental | Drug: Cannabidiol, Drug: GemcitabineCannabidiol (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. |
| GBM: Chemo + Placebo | Placebo comparator | Drug: TemozolomideStandard 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). |
| GBM: Chemo + BRCX014 | Experimental | Drug: Cannabidiol, Drug: TemozolomideCannabidiol (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). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Signed and dated informed consent
- Male and Females age 18 to 80 years old at the time of screening
- Confirmed tissue diagnosis of Multiple myeloma, GI malignancy by a licensed pathologist
- A performance status 0-1 on the Eastern Cooperative Oncology Group (ECOG) scale.
- Females of childbearing potential willing to utilize two approved forms of contraceptives (e.g., birth control, abstinence, spermicidal lube, intrauterine device [IUD])
Key exclusion criteria (9 listed)
- Subject is pregnant or plans to become pregnant or actively lactating/nursing
- Hypersensitivity to any ingredient in the study product
- Initial laboratory values as determined by the principal investigator to be clinically significant
- A substance abuse history within the last five years
- Any diseases or conditions that may interfere with the conduct of the study or interpretation of the study results
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CannabidiolAlso: BRCX014, bioRenovate CX* 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 | Drug | Colon: Chemo + BRCX014, GBM: Chemo + BRCX014, Multiple myeloma: Chemo + BRCX014, Pancreatic: Chemo + BRCX014, Rectal: Chemo + BRCX014 |
| BortezomibAlso: VelcadeStandard 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. | Drug | Multiple myeloma: Chemo + BRCX014, Multiple myeloma: Chemo + Placebo |
| LeucovorinAlso: Folinic acidStandard 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. | Drug | Colon: Chemo + BRCX014, Colon: Chemo + Placebo, Rectal: Chemo + BRCX014, Rectal: Chemo + Placebo |
| 5-FUAlso: EfudexStandard 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. | Drug | Colon: Chemo + BRCX014, Colon: Chemo + Placebo, Rectal: Chemo + BRCX014, Rectal: Chemo + Placebo |
| OxaliplatinAlso: EloxatinStandard 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. | Drug | Colon: Chemo + BRCX014, Colon: Chemo + Placebo, Rectal: Chemo + BRCX014, Rectal: Chemo + Placebo |
| BevacizumabAlso: AvastinStandard 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. | Drug | Colon: Chemo + BRCX014, Colon: Chemo + Placebo, Rectal: Chemo + BRCX014, Rectal: Chemo + Placebo |
| IrinotecanAlso: CamptosarStandard 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. | Drug | Colon: Chemo + BRCX014, Colon: Chemo + Placebo, Rectal: Chemo + BRCX014, Rectal: Chemo + Placebo |
| GemcitabineAlso: GemzarStage IV pancreatic cancer will include a gemcitabine-based regiment at 1000 mg/m2 day 1, 7, 15 of a 21-day cycle. | Drug | Pancreatic: Chemo + BRCX014, Pancreatic: Chemo + Placebo |
| TemozolomideAlso: TemodarStandard 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). | Drug | GBM: Chemo + BRCX014, GBM: Chemo + Placebo |
Primary outcome
Response rate
Time frame: Through study completion, an average of one year
The primary objective of this study is to evaluate the overall response rates of cancer patients as assessed by standard criteria.
4 secondary outcomes
Time to progression (TTP) in patients using lab results and radiographic data.
Time frame: Through study completion, an average of one year
Progression-free survival (PFS) in patients using lab results and radiographic data.
Time frame: Through study completion, an average of one year
Quality-of-life assessment in patients using patient-reported outcomes (PRO) data.
Time frame: Through study completion, an average of one year
Quality-of-life assessment in patients using clinician-reported outcomes (ClinRO) data.
Time frame: Through study completion, an average of one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah F Katta, DO principal investigator
Leaf Vertical Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Cannabidiol, Bortezomib and Leucovorin in people with Cancer of Pancreas and Cancer of Liver, run by Leaf Vertical Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philip Arlen, PhD (407-443-0656, parlen@leafvertical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate (time frame: Through study completion, an average of one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2018.