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BP31510 (Ubidecarenone,USP) Nanosuspension for Intravenous Injection to Patients With Solid Tumors

NCT01957735 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 97

Last updated 2025-02-19

No results posted yet for this study

Summary

This is a Phase 1a/b multicenter, open-label, non-randomized, dose-escalation study to examine the dose limiting toxicities (DLT) of BPM31510 administered as a 144-hour continuous intravenous (IV) infusion as monotherapy(treatment Arm 1) and in combination with chemotherapy (treatment Arm 2) in patients with solid tumors.

Conditions

Interventions

DRUG

BP31510 monotherapy

DRUG

BP31510 in combination with chemotherapy

Sponsors & Collaborators

  • BPGbio

    lead INDUSTRY

Principal Investigators

  • Manish A Shah, MD · Weill Cornell Solid Tumor Oncology Practice

  • Vivek Subbiah, MD · M.D. Anderson Cancer Center

  • Kim-Son Nguyen, MD · Palo Alto Medical Foundation

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2017-02-01
Completion
2017-02-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01957735 on ClinicalTrials.gov