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A Phase 1, Multi-Center, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Minnelide™ Capsules Given Alone or in Combination With Protein-Bound Paclitaxel in Patients With Advanced Solid Tumors

NCT03129139 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2023-10-18

No results posted yet for this study

Summary

A Phase I, Multicenter, Open-label, Dose-Escalation, Safety, Pharmacokinetic and Pharmacodynamic Study of Minnelide™Capsules given daily for 21 days followed by 7 days off schedule in patients with Advanced Solid Tumors

Conditions

Interventions

DRUG

Minnelide™Capsules

Minnelide™ is a water soluble disodium salt variant of triptolide an heat shock protein (HSP) inhibitor.

Sponsors & Collaborators

  • Translational Drug Development

    collaborator OTHER

  • Minneamrita Therapeutics LLC

    lead INDUSTRY

Principal Investigators

  • Jordan Jacobs, MBA · Translational Drug Development

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-10
Primary Completion
2024-06-01
Completion
2024-12-01
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 NCT03129139 on ClinicalTrials.gov