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A Dose Escalation Study of LNA-i-Mir-221 for Cancer Treatment

NCT04811898 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2022-02-01

No results posted yet for this study

Summary

The LNA-i-miR-221 Phase I trial has been designed as a monocentric open label dose escalation study which received written approval by the Competent Authority and independent Ethics Committee (IEC). LNA-i-miR-221 will be investigated for safety and tolerability in patients, men and women age ≥18 yrs, affected by Refractory-MM and advanced solid tumors.

Conditions

  • Multiple Myeloma, Refractory
  • Hepatocarcinoma
  • Advanced Solid Tumor

Interventions

BIOLOGICAL

LNA-i-miR-221

LNA-i-miR-221, IV daily infusion on days 1-4 followed by 24 days washout (1 cycle lasting 28 days)

Sponsors & Collaborators

  • Associazione Italiana per la Ricerca sul Cancro

    collaborator OTHER

  • Azienda Ospedaliera Universitaria Mater Domini, Catanzaro

    lead OTHER

Principal Investigators

  • Pierfrancesco Tassone, MD · Translational Medical Oncology Unit, AOU MaterDomini and Magna Graecia University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-14
Primary Completion
2021-12-29
Completion
2021-12-29

Countries

  • Italy

Study Locations

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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 NCT04811898 on ClinicalTrials.gov