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Safety and Pharmacokinetics of Rising Doses of APO010 in Relapsed/Refractory Multiple Myeloma Patients Selected by DRP

NCT03196947 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2020-01-30

No results posted yet for this study

Summary

Multicentre, open label, uncontrolled, phase I pharmacokinetic study, to determine the Maximum Tolerated Dose (MTD) of APO010 administered intravenously on D1, D8 and D15 followed by a one-week drug rest, in patients with multiple myeloma for who have relapsed or are refractory to 2 (in high-risk patients 1) or more different prior therapies and who have Drug Response Predictor (DRP) for APO010 indicating a higher likelihood for response to APO010. The study will contain an extension phase where the recommended Dose will be tested on additional patients.

Conditions

Interventions

DRUG

APO010

APO010 is given iv on D1, D8 and D15 followed by a one-week drug rest (cycle duration 4 weeks).

Sponsors & Collaborators

  • Smerud Medical Research International AS

    collaborator OTHER

  • Medical Prognosis Institute A/S

    collaborator INDUSTRY

  • Allarity Therapeutics

    lead INDUSTRY

Principal Investigators

  • Annette J Vangsted, DMSc · Rigshospitalet, Finsen Centre, Hematological Department,, Phase 1 Unit

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-13
Primary Completion
2020-01-16
Completion
2020-01-16

Countries

  • Denmark

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 NCT03196947 on ClinicalTrials.gov