NCT03275103 : An Open-Label, Multicenter, Phase I Trial Evaluating the Safety and Pharmacokinetics of Escalating Doses of BFCR4350A in Patients With Relapsed or Refractory Multiple Myeloma

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

OnePhase One

18+Age Over 18

Blood<br/>CancersCancer LocationBlood
Cancers

Systemic therapy | Blood / Myeloma / LymphomaMultiple Myeloma

Trial Overview Read MoreRead more

This phase I trial is evaluating an intravenous drug (BFCR4350A) in patients with multiple myeloma, who have progressed or not responded to prior treatment .
 

This trial is treating patients with Multiple Myeloma.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

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Scientific Title

An Open-Label, Multicenter, Phase I Trial Evaluating the Safety and Pharmacokinetics of Escalating Doses of BFCR4350A in Patients With Relapsed or Refractory Multiple Myeloma

Commercial Sponsor

Genentech

Summary

Dose escalation: The study drug will be administered intravenously on a 21-day cycle. Initially, cohorts will consist of 1 participant each. Subsequently will consist of at least 3 participants, unless dose-limiting toxicities (DLTs) are observed in the first 2 prior to enrollment of a third participant. For each cohort, treatment with the first dose will be staggered such that the second participant enrolled in the cohort will receive study drug at least 72 hours after the first participant receives it to allow assessment of any severe and unexpected acute or subacute drug or infusion-related toxicities; dosing in subsequent participants in each cohort will be staggered by at least 24 hours. Expansion: Participants exhibiting acceptable safety and evidence of clinical benefit will be administered study drug every 21 days up to a maximum of 17 cycles until objective disease progression is documented or unacceptable toxicity, whichever occurs first.

Recruiting Hospitals Read MoreRead more

PCCTU (Parkville Cancer Clinical Trials Unit) *
Parkville
Ms Marian Lieschke
marian.lieschke@petermac.org
03 8559 7140

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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