Search Cancer Clinical Trials

The Cancer Center offers patients access to a wide variety of clinical trials of promising new therapies. Use the search tool to find open protocols for your type of cancer.
Search by condition
Search By:
Protocol # 20-177

Status

Recruiting

Description

The purpose of this study is to evaluate the safety, tolerability, and antitumor activity of BGB-3245 in participants with advanced or refractory solid tumors

Condition

  • Solid Tumor
  • B-Raf Mutation-Related Tumors

Interventions

  • BGB-3245

Phase

Phase 1

Study Type

Interventional

Further Study Details

Primary Outcome:

  • Phase 1a: Number of Participants and Severity Experiencing Adverse Events (AEs)
  • Phase 1a: Number of Participants and Severity Experiencing Serious Adverse Events (SAEs)
  • Phase 1a: number of Participants Experiencing AEs meeting protocol defined Dose-Limiting Toxicity (DLT) criteria
  • Phase 1a: Maximum Tolerated Dose (MTD) of BGB-3245, and the recommended Phase 2 Dose (RP2D) for BGB-3245
  • Phase 1b: Objective Response Rate (ORR) confirmed Complete Response and Partial Response

Secondary Outcome:

  • Phase 1a: Overall Response Rate (ORR) as Assessed by the Investigator
  • Phase 1a: Duration of Response (DOR) as Assessed by the Investigator
  • Phase 1a: Clinical Benefit Rate (CBR) as Assessed by the Investigator
  • Phase 1a: Best Overall Response (BOR) as Assessed by the Investigator
  • Phase 1a: Duration of Stable Disease (DSD)
  • Phase 1a: Progression Free Survival (PFS)
  • Phase 1a: Plasma Concentration of BGB-3245
  • Phase 1a: Maximum Observed Plasma Concentration (Cmax) of BGB-3245
  • Phase 1a: Time to Maximum Plasma Concentration (Tmax) of BGB-3245
  • Phase 1a: Time Taken for Half the Initial Dose Administered To Be Eliminated From The Body (T1/2) of BGB-3245
  • Phase 1a: Area Under the Concentration-Time Curve of 0-infinity Days (AUC0-inf) of BGB-3245
  • Phase 1a:Area Under the Concentration-Time Curve of 0-Last hour (AUC0-last) of BGB-3245
  • Phase 1a: Drug Clearance (CL/F) of BGB-3245
  • Phase 1a: Apparent Volume of Distribution (Vz/F) of BGB-3245
  • Phase 1a: Steady State Area Under the Concentration-Time Curve of 0- Last hour (AUCLast, ss) of BGB-3245
  • Phase 1a: Steady State Maximum Observed Plasma Concentration (Cmax, ss) of BGB-3245
  • Phase 1a: Steady State Time to Maximum Plasma Concentration (Tmax, ss) of BGB-3245
  • Phase 1b: Progression-free survival (PFS) as Assessed by the Investigator
  • Phase 1b: Duration of Response (DOR) as Assessed by the Investigator
  • Phase 1b: Disease-Control Rate (DCR) as Assessed by the Investigator
  • Phase 1b: Duration of Stable Disease (DSD) as Assessed by the Investigator
  • Phase 1b: Clinical Benefit Rate (CBR) as Assessed by the Investigator
  • Phase 1b: Overall Survival
  • Phase 1b: Number of Participants Experiencing Adverse Events (AEs)
  • Phase 1b: Number of Participants Experiencing Serious Adverse Events (SAEs)
  • Phase 1b: Plasma Concentration of BGB-3245
  • Phase 1b: Steady State Trough Observed Plasma Concentration (Ctrough, SS) of BGB-3245

Enrollment

168

Study Start Date

February 17, 2020

Eligibility

  • Gender:     All
  • Minimum age:     18 Years
  • Maximum age:     N/A
  • Healthy volunteers:     No

Sponsors

MapKure, LLC

Source

MapKure, LLC

Official title

A First-in-Human, Phase 1a/1b, Open Label, Dose-Escalation and Expansion Study to Investigate the Safety, Pharmacokinetics, and Antitumor Activity of the RAF Dimer Inhibitor BGB-3245 in Patients With Advanced or Refractory Tumors

Clinicaltrials.gov Identifier

NCT04249843

     

Source: Clinicaltrials.gov. Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.