Phase 1b: (Dose Expansion) for Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Florida Cancer Specialists-Sarasota, Santa Rosa Beach, FL
Cancer+1 More
Paclitaxel - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This is an open-label, multicenter, and non-randomized Phase 1a/1b clinical study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BGB-24714 as monotherapy and in combination with chemotherapy in participants with advanced or metastatic solid tumors.

Eligible Conditions

  • Cancer
  • Solid Tumors, Adult

Treatment Effectiveness

Study Objectives

4 Primary · 7 Secondary · Reporting Duration: approximately 2 Years

approximately 2 Years
Disease Control Rate (DCR)
Dose Escalation: Objective response rate (ORR)
Dose Expansion: Number of participants with adverse events
Dose Expansion: Objective response rate (ORR)
Dose Expansion: Progression-free Survival (PFS)
Duration of Response (DOR)
Plasma Concentrations of BGB-24714 metabolite
Plasma concentration of BGB-24714
approximately 6 months
Dose Escalation: Maximum tolerated dose (MTD) of BGB-24714 as monotherapy and in combination with chemotherapy
Dose Escalation: Number of participants with adverse events (AEs)
Dose Escalation: Recommended Phase 2 dose (RP2D) of BGB-24714 as monotherapy and in combination with chemotherapy

Trial Safety

Trial Design

3 Treatment Groups

Phase 1b: (Dose Expansion)
1 of 3
Phase 1a: Dose Escalation Part B
1 of 3
Phase 1a: Dose Escalation Part A
1 of 3
Experimental Treatment

244 Total Participants · 3 Treatment Groups

Primary Treatment: Phase 1b: (Dose Expansion) · No Placebo Group · Phase 1

Phase 1b: (Dose Expansion)Experimental Group · 2 Interventions: Paclitaxel, BGB-24714 · Intervention Types: Drug, Drug
Phase 1a: Dose Escalation Part BExperimental Group · 2 Interventions: Paclitaxel, BGB-24714 · Intervention Types: Drug, Drug
Phase 1a: Dose Escalation Part A
Drug
Experimental Group · 1 Intervention: BGB-24714 · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
2011
Completed Phase 4
~6340

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: approximately 2 years
Closest Location: Florida Cancer Specialists-Sarasota · Santa Rosa Beach, FL
2015First Recorded Clinical Trial
0 TrialsResearching Cancer
2 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You must sign a written informed consent form (ICF) and agree to comply with study requirement.
Patients with histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumor previously treated with standard systemic therapy or for whom treatment is not available or not tolerated.
You must be able to provide an archived formalin-fixed paraffin embedded (FFPE) tumor tissue sample
You have at least one detectable lesion on a CT scan or MRI scan.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.