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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
IV. Group 4: Patients with cutaneous melanoma harboring an NRAS mutation who consent to paired fresh biopsies.
III. Group 3: Patients with cutaneous melanoma harboring a neuroblastoma RAS viral oncogene homolog (NRAS) mutation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 36 months
Awards & highlights
Study Summary
This trial will test the safety and effectiveness of a new drug, BGB-3245, for treating people with advanced or refractory solid tumors.
Who is the study for?
This trial is for adults with advanced solid tumors that have worsened after treatment or lack treatment options. They must have specific mutations in the BRAF, NRAS, or KRAS genes and can't be undergoing cancer therapy at the start. Those with certain medical conditions like HIV or active hepatitis, gastrointestinal issues affecting drug absorption, or symptomatic brain metastases are excluded.Check my eligibility
What is being tested?
The study tests BGB-3245's safety and effectiveness against advanced solid tumors with particular genetic mutations. It has two phases: Phase 1a includes various tumor types and mutations; Phase 1b focuses on four groups based on mutation type and cancer kind.See study design
What are the potential side effects?
While not specified here, side effects of BGB-3245 may include typical reactions to anticancer medications such as nausea, fatigue, skin reactions, blood count changes leading to increased infection risk or bleeding problems.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have skin cancer with an NRAS mutation and agree to provide fresh tissue samples.
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My skin cancer has an NRAS mutation.
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My non-CRC cancer has a BRAF V600 mutation and has worsened despite previous BRAF/MEK inhibitor treatments.
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My advanced cancer has a specific BRAF mutation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 36 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase 1a: Maximum Tolerated Dose (MTD) of BGB-3245, and the recommended Phase 2 Dose (RP2D) for BGB-3245
Phase 1a: Number of Participants and Severity Experiencing Adverse Events (AEs)
Phase 1a: Number of Participants and Severity Experiencing Serious Adverse Events (SAEs)
+3 moreSecondary outcome measures
Phase 1a: Apparent Volume of Distribution (Vz/F) of BGB-3245
Phase 1a: Area Under the Concentration-Time Curve of 0-infinity Days (AUC0-inf) of BGB-3245
Phase 1a: Best Overall Response (BOR) as Assessed by the Investigator
+24 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Phase 1b, Group 1: Dose ExpansionExperimental Treatment1 Intervention
BGB-3245 administered orally (PO)
Group II: Phase 1a: Dose EscalationExperimental Treatment1 Intervention
BGB-3245 administered orally (PO)
Find a Location
Who is running the clinical trial?
MapKure, LLCLead Sponsor
1 Previous Clinical Trials
64 Total Patients Enrolled
Brandon Beagle, MDStudy DirectorBeiGene
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had chemotherapy with nitrosourea or mitomycin C in the last 6 weeks.My advanced cancer has worsened after treatment or I can't tolerate available treatments.I have skin cancer with an NRAS mutation and agree to provide fresh tissue samples.I do not have any major health conditions that would make it unsafe for me to take the study drug.My skin cancer has an NRAS mutation.I don't have symptoms from brain or spinal cancer spread, but if present, they're stable.I haven't taken any experimental drugs or targeted cancer therapies within the last 4 weeks or 5 times the half-life of the drug, whichever is shorter.I have not had cancer treatment recently.I do not have any stomach or intestine problems that affect how my body handles medicine.My non-CRC cancer has a BRAF V600 mutation and has worsened despite previous BRAF/MEK inhibitor treatments.My tumor has a specific BRAF, NRAS, or KRAS mutation, but not in colorectal or pancreatic cancer.I am not currently undergoing any cancer treatments.My advanced cancer has a specific BRAF mutation.I know my mutation status and meet the specific criteria for my group.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 1a: Dose Escalation
- Group 2: Phase 1b, Group 1: Dose Expansion
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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