Clinical trial for Colorectal Cancer
Official title BOLD-100 in Combination With FOLFOX With or Without Bevacizumab for the Treatment of Advanced, Solid Tumours
ClinicalTrials.gov ID: NCT04421820
What this study is testing
What is BOLD-100 +/- FOLFOX Chemotherapy (Arm VII)?
An investigational combination of the drug BOLD-100 with the standard FOLFOX chemotherapy regimen being studied for colorectal cancer.
Also referred to as BOLD-100.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to see if adding BOLD‑100 to standard FOLFOX treatment is safe and how well it works in advanced solid tumors.
- Who it's for
- Adults with advanced colorectal, pancreatic, gastric, or cholangiocarcinoma who have not responded to other treatments.
- What's involved
- Participants receive BOLD‑100 through an IV along with regular FOLFOX chemotherapy, with doses adjusted in early groups to check safety, then expanded to more patients.
- Time commitment
- The trial lasts several months, with multiple clinic visits for drug infusions, blood tests, and safety monitoring.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Be 18 years or older.
- Be male or non-pregnant females who agree to comply with applicable contraceptive requirements of the protocol.
- Histologically and/or cytologically confirmed gastrointestinal tumours that are metastatic or unresectable, and are subject to receive FOLFOX ±...
- Have measurable disease according to RECIST v1.1.
- Have an anticipated survival of at least 16 weeks.
You likely can't join if
- Neuropathy \> grade 2
- Previous intolerance to or significant reaction secondary to fluorouracil, oxaliplatin, or bevacizumab.
- Cerebrovascular accident within the past 6 months before the start of treatment.
- History or presence of central nervous system (CNS) metastasis or leptomeningeal tumours.
- Any serious medical conditions that might be aggravated by treatment or limit compliance.
- Any history of serious cardiac illness.
See the full eligibility criteria
- Be 18 years or older.
- Be male or non-pregnant females who agree to comply with applicable contraceptive requirements of the protocol.
- Histologically and/or cytologically confirmed gastrointestinal tumours that are metastatic or unresectable, and are subject to receive FOLFOX ± Bevacizumab.
- Have measurable disease according to RECIST v1.1.
- Have an anticipated survival of at least 16 weeks.
- Be ambulatory, with an ECOG performance score of 0 or 1.
- Have adequate organ function.
- Be on stable doses of any drugs that may affect hepatic drug metabolism or renal drug excretion.
- Be fully informed about their illness and the investigational nature of the study protocol, and sign a REB-approved Informed Consent Form (ICF).
- (ARM VII): BRAF wild-type tumour status.
- Neuropathy \> grade 2
- Previous intolerance to or significant reaction secondary to fluorouracil, oxaliplatin, or bevacizumab.
- Cerebrovascular accident within the past 6 months before the start of treatment.
- History or presence of central nervous system (CNS) metastasis or leptomeningeal tumours.
- Any serious medical conditions that might be aggravated by treatment or limit compliance.
- Any history of serious cardiac illness.
- Hemoptysis, cerebral, or clinically significant gastrointestinal hemorrhage in the past 6 months before the start of treatment.
- Any other known malignancy within 3 years before the start of treatment.
- Active gastrointestinal tract disease with malabsorption syndrome.
- Non-healing wound, fracture, or ulcer, or presence of symptomatic peripheral vascular disease.
- Treatment with radiation therapy or surgery within 4 weeks prior to starting treatment.
- Recent history of weight loss \> 10% of current body weight in past 3 months before the start of treatment.
- HIV-positive people on combination anti-retroviral therapy due to the potential for PK interactions with the study agent.
- Concurrent use of another investigational therapy or anti-cancer therapy within 4 weeks before the start of treatment.
- Currently breastfeeding
- Dihydropyrimidine Dehydrogenase (DPD) deficiency
- Current or prior treatment with potent inhibitors of Dihydropyrimidine Dehydrogenase (DPD)
- (ARM VII): Prior exposure to BOLD-100
- (ARM VII): people with microsatellite-high (MSI-H) Tumours
- (ARM VII): Concurrent monoclonal antibody therapy for mCRC (anti-EGFR, anti-VEGF or anti-HER2)
The study team makes the final eligibility decision.
Where it is enrolling
- Edmonton, Alberta, Canada
- Hamilton, Ontario, Canada
- Ottawa, Ontario, Canada
- Toronto, Ontario, Canada
- Montreal, Quebec, Canada
- Bonn, Germany
- Ulm, Germany
- Dublin, Ireland
- Milan, Italy
- Naples, Italy
- Pisa, Italy
- Goyang, South Korea
- Seoul, South Korea
- Barcelona, Spain
- Madrid, Spain
- Cardiff, United Kingdom
- Dundonald, United Kingdom
- London, United Kingdom
- Sutton, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Edmonton, Alberta, Canada; Hamilton, Ontario, Canada; Ottawa, Ontario, Canada; Toronto, Ontario, Canada; Montreal, Quebec, Canada; Bonn, Germany and 13 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.