NCT03288480

A Phase 1/2a Dose-Finding Study of PT-112 in Patients With Relapsed or Refractory Multiple Myeloma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Promontory Therapeutics Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Study PT-112-102, a multicenter, open-label dose-finding and pharmacokinetic study of PT-112 in patients with relapsed or refractory multiple myeloma. This is designed as a two-part study. In the first part of the study, cohorts of three patients (expanded to six patients in the event of a dose-limiting toxicity) will receive escalating doses of PT-112 until the MTD is reached, based on tolerability observed during the first 28 days of treatment. In the second part of the study, an expansion cohort of 14 patients will be treated at the recommended dose to confirm the tolerability of treatment and evaluate evidence of treatment efficacy.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	PT-112	This is a single arm study

Timeline

• Start date: 2017-12-15
• Primary completion: 2020-09-30
• Completion: 2021-03-01
• First posted: 2017-09-20
• Last updated: 2022-04-26

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study