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Phase 1b/2 Study of Liposomal Annamycin (L-Annamycin) in Subjects With Previously Treated Soft-Tissue Sarcomas (STS) With Pulmonary Metastases

NCT05518526 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2022-08-26

No results posted yet for this study

Summary

This study is a multi-centre, open-label, single-arm, 3+3 Phase 1b/ and Phase II. Phase 1b is aimed to determine the maximum-tolerated dose (MTD)/Recommended Phase 2 Dose (RP2D) based on safety reporting. The RP2D is a multifactorial endpoint that considers toxicity as well as additional determinants (e.g. efficacy, pharmacodynamics) to define the optimal Phase 2 dose. Phase 2 will explore the efficacy of L-Annamycin at RP2D for treating soft tissue sarcomas (STS) subjects with lung metastases, for which chemotherapy is considered appropriate.

Conditions

  • Soft Tissue Sarcoma
  • Pulmonary Metastasis

Interventions

DRUG

Liposomal Annamycin (L-Annamycin)

Study drug consists of L-Annamycin as a lyophilised powder in 50-mL single-use vials containing 45 mg of L-Annamycin must be reconstituted with 45 mL of 0.9% sodium chloride injection between 34 to 42℃, USP, and then diluted 1:1 with 0.9% sodium chloride injection between 34 to 42℃ in non-polyvinyl chloride IV bags before intravenous infusion. The dose of L-Annamycin will be intravenously applied during 2 hours infusion on D1, D8, and D15 of each 28-day cycle (up to Cycle 6th).

Sponsors & Collaborators

  • Maria Sklodowska-Curie National Research Institute of Oncology

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-23
Primary Completion
2025-08-31
Completion
2025-08-31

Countries

  • Poland

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 NCT05518526 on ClinicalTrials.gov