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Anti-tumor antibiotic

Liposomal Annamycin for Soft Tissue Sarcoma

Phase 1 & 2
Waitlist Available
Research Sponsored by Moleculin Biotech, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
At least 2 weeks must have passed following treatment for subject's disease with chemotherapy, investigational therapy, targeted agents, biological agents, immune modulators, or radiotherapy. Any toxicities must have resolved to ≤ grade 1 or previous baseline levels no more than 4 weeks after completing therapy (except alopecia and polyneuropathy).
The subject must have the following adequate laboratory results within 72 hours of starting protocol therapy: Absolute neutrophil count ≥ 1500/mL, Platelet count ≥100,000/mL, Hemoglobin ≥ 8.0 g/dL, Adequate renal function, Bilirubin ≤1.5 x ULN (unless due to Gilbert's syndrome), Aspartate aminotransferase and/or alanine aminotransferase ≤ 2.5 × ULN (≤ 5 x ULN in subjects with liver metastases).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up cycle 1 day 1 ( each cycle is 21 days)
Awards & highlights

Study Summary

This trial will study the effects of a new cancer drug called L-Annamycin. The first part of the trial will focus on finding the best dose of the drug, and the second part will focus on whether the drug can shrink tumors.

Who is the study for?
This trial is for adults with soft-tissue sarcomas that have spread to the lungs and are not candidates for surgery. Participants must have a life expectancy over 3 months, measurable lung disease, adequate blood counts and organ function, and no severe heart conditions or uncontrolled illnesses. They should be past certain treatments with resolved side effects (except hair loss and neuropathy) and agree to use contraception.Check my eligibility
What is being tested?
The study tests Liposomal Annamycin (L-Annamycin), an experimental drug for treating lung metastases from soft-tissue sarcoma. Phase 1b determines the safest dose while Phase 2 assesses its effectiveness as a single treatment agent in multiple centers.See study design
What are the potential side effects?
Potential side effects of L-Annamycin may include typical chemotherapy-related issues such as fatigue, nausea, low blood cell counts leading to increased infection risk or bleeding problems, liver toxicity, and possibly heart-related complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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It's been over 2 weeks since my last cancer treatment, and any side effects are mild or gone.
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Your recent blood tests show normal levels for white blood cells, platelets, and hemoglobin. Your kidneys and liver are working well, and your bilirubin levels are within a certain range.
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My lung cancer has spread, and surgery is not an option, but I can receive chemotherapy.
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I am 18 years old or older.
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My diagnosis of soft tissue sarcoma is confirmed by a pathology report.
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I am able to get out of my bed or chair and move around.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~cycle 1 day 1 ( each cycle is 21 days)
This trial's timeline: 3 weeks for screening, Varies for treatment, and cycle 1 day 1 ( each cycle is 21 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose Limiting Toxicity
Secondary outcome measures
Area Under the Plasma Concentration Versus Time Curve (AUC) of L-Annamycin
Efficacy of L-Annamycin

Trial Design

1Treatment groups
Experimental Treatment
Group I: Liposomal Annamycin (L-Annamycin)Experimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Moleculin Biotech, Inc.Lead Sponsor
6 Previous Clinical Trials
182 Total Patients Enrolled
Robert Shepard, MDStudy DirectorMoleculin Biotech, Inc.
3 Previous Clinical Trials
90 Total Patients Enrolled

Media Library

Liposomal Annamycin (Anti-tumor antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT04887298 — Phase 1 & 2
Soft Tissue Sarcoma Research Study Groups: Liposomal Annamycin (L-Annamycin)
Soft Tissue Sarcoma Clinical Trial 2023: Liposomal Annamycin Highlights & Side Effects. Trial Name: NCT04887298 — Phase 1 & 2
Liposomal Annamycin (Anti-tumor antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04887298 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this pioneering clinical trial a unique endeavor?

"To date, Moleculin Biotech Inc.'s Liposomal Annamycin (L-Annamycin) is only being trialled in 5 cities and 1 country. The initial 2021 drug approval trial was concluded with 55 participants successfully completing the Phase 1 & 2 stages. As of now, a single study has been completed for this medication."

Answered by AI

How many sites are conducting this research trial?

"There are a total of 5 sites that are signing up patients for this clinical trial, including the Washington University in Saint Louis, Rutgers Cancer Institute of New jersey in New Brunswick and Sarcoma Oncology Center in Santa Monica. Additionally, two other locations have been identified as potential recruitment centres."

Answered by AI

Has Liposomal Annamycin (L-Annamycin) been utilized in any prior clinical experiments?

"Currently, only one clinical trial is underway for Liposomal Annamycin (L-Annamycin) with none in Phase 3. These studies are predominantly based around Columbus, Ohio but 5 other medical facilities have begun research into this medication."

Answered by AI

How many participants have been recruited to join this experiment?

"In order to successfully commence this medical trial, we must enroll 55 qualified participants. Washington University in Saint Louis and Rutgers Cancer Institute of New jersey are two potential sites for participant recruitment."

Answered by AI

Is recruitment underway for this clinical experiment?

"According to the details hosted on clinicaltrials.gov, this trial is currently enrolling participants. The initial posting date was June 5th 2021 and it has been augmented with new information as recently as August 16th 2022."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study of Liposomal Annamycin for the Treatment of Subjects With Soft-Tissue Sarcomas (STS) With Pulmonary Metastases
2021. "Study of Liposomal Annamycin for the Treatment of Subjects With Soft-Tissue Sarcomas (STS) With Pulmonary Metastases". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04887298.
~0 spots leftby May 2024
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