Study of Liposomal Annamycin for the Treatment of Subjects With Soft-Tissue Sarcomas (STS) With Pulmonary Metastases
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|ClinicalTrials.gov Identifier: NCT04887298|
Recruitment Status : Recruiting
First Posted : May 14, 2021
Last Update Posted : February 10, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Sarcoma,Soft Tissue Pulmonary Metastasis||Drug: Liposomal Annamycin (L-Annamycin)||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||55 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 1B/2 Study Of Liposomal Annamycin (L-Annamycin) In Subjects With Previously Treated Soft-Tissue Sarcomas With Pulmonary Metastases|
|Actual Study Start Date :||June 5, 2021|
|Estimated Primary Completion Date :||May 2023|
|Estimated Study Completion Date :||May 2024|
|Experimental: Liposomal Annamycin (L-Annamycin)||
Drug: Liposomal Annamycin (L-Annamycin)
2-hour intravenous (IV) infusion of L-Annamycin on Day 1 followed by 20 days off of study drug (i.e., 1 treatment cycle= 21 days)
- Dose Limiting Toxicity [ Time Frame: 21 days ]Number of patients with a dose limiting toxicity (DLT) at each dose evaluated
- Efficacy of L-Annamycin [ Time Frame: At the end of every other treatment cycle ( each cycle is 21 days) ]Determine preliminary efficacy of L-Annamycin as per revised Response Evaluation Criteria in Solid Tumors (RECIST) guidelines (version 1.1)
- Area Under the Plasma Concentration Versus Time Curve (AUC) of L-Annamycin [ Time Frame: Cycle 1 Day 1 ( each cycle is 21 days) ]Determine pharmacokinetics of L-Annamycin and its metabolite, annamycinol as measured by AUC
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- The subject has a pathologically confirmed diagnosis of STS.
- The subject must have radiographically measurable disease in the lung that can be assessed using RECIST v.1.1 (defined as the presence of at least one lesion on MRI or CT scan that can be accurately measured with the longest diameter in at least one dimension of ≥10 mm). Subjects with extra-pulmonary disease are eligible.
- The subject has documented lung metastases that are considerable eligible for chemotherapy and not eligible for potentially curative surgical resection of pulmonary-only metastatic disease.
- The subject had prior therapy for their disease and has shown progression of disease prior to study entry. If the subject received prior anthracycline therapy, they must have received a cumulative dose of ≤ 450 mg/m2.
- The subject has an estimated life expectancy of greater than 3 months.
- The subject has an ECOG performance status ≤2.
- The subject is ≥18 years old at the time of signing informed consent.
- 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 (The Cockcroft-Gault equation will be used to estimate creatinine clearance.
CrCl (male) = ([140-age] x weight in kg) / (serum creatinine x 72)
CrCl (female) = ([140-age] x weight in kg) / (serum creatinine x 72) x .85
- Bilirubin ≤1.5 x ULN (unless due to Gilbert's syndrome)
- Aspartate aminotransferase (serum glutamic oxaloacetic transaminase) and/or alanine aminotransferase (serum glutamic pyruvic transaminase) ≤ 2.5 × ULN (≤ 5 x ULN in subjects with liver metastases)
- The subject is able to understand and sign the informed consent document, can communicate with the Investigator, and can understand and comply with the requirements of the protocol.
All subjects must agree to practice effective contraception during the entire study period and after discontinuing study drug, unless documentation of infertility exists.
- Sexually active, fertile women must agree to use 2 effective forms of contraception (abstinence, intrauterine device, oral contraceptive, or double barrier device) from the time of informed consent and until at least 6 months after discontinuing study drug
- Sexually active men and their sexual partners must agree to use effective contraceptive methods from the time of informed consent until at least 6 months after discontinuing study drug
The subject has any uncontrolled intercurrent illness that, in the opinion of the Investigator, would place the subject at unacceptable risk to participate in the study. Examples include, but are not limited to:
- Ongoing or active infection
- Known positive status for human immunodeficiency virus (HIV) or active hepatitis B or C
- Psychiatric illness/social situations that would limit compliance with study requirements
The subject has any of the following cardiotoxicities:
- Left ventricular ejection fraction (LVEF) <50%
- Valvular heart disease
- Severe hypertension not controlled by medical therapy
- New York Heart Association classification of 3 or 4 (Appendix B)
- Recent (≤ 6 months) myocardial infarction
- Unstable angina
- Symptomatic congestive heart failure
- Baseline QT/QTc interval >480 msec
- History of additional risk factors for torsade des pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
- Use of concomitant medications that significantly prolong the QT/QTc interval
- The subject is pregnant (must have negative serum or urine pregnancy test) or lactating.
- The subject has a known allergy to study drug, L-Annamycin, or excipients.
- The subject is required to use moderate or strong inhibitors and inducers of Cytochrome P450 family enzymes CYP3A and CYP2B and transporters that cannot be held 3 days before treatment and on the day of treatment (Appendix E).
- The subject is unable to comply with the safety monitoring requirements.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04887298
|Contact: Robert Shepard, MD||(713) email@example.com|
|Contact: Cynthia Abbate||(713) firstname.lastname@example.org|
|United States, California|
|Sarcoma Oncology Center||Recruiting|
|Santa Monica, California, United States, 90403|
|Contact: Victoria Chua-Alcala 310-552-9999 email@example.com|
|Principal Investigator: Sant Chawla, MD|
|United States, Missouri|
|Saint Louis, Missouri, United States, 63110|
|Contact: Michele Landeau firstname.lastname@example.org|
|Principal Investigator: Brian Van Tine, MD/PhD|
|United States, New Jersey|
|Rutgers Cancer Institute of New Jersey||Recruiting|
|New Brunswick, New Jersey, United States, 08903|
|Contact: Pooja Shah email@example.com|
|Principal Investigator: Sarah Weiss, MD|
|United States, Ohio|
|Ohio State University||Recruiting|
|Columbus, Ohio, United States, 43210|
|Contact: Danielle Dever 614-685-9353 Danielle.firstname.lastname@example.org|
|Principal Investigator: David Liebner, M.D.|
|United States, Texas|
|The University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Min Du 713-792-3626 email@example.com|
|Principal Investigator: Maria A Zarzour, MD|
|Study Director:||Robert Shepard, MD||Moleculin Biotech, Inc.|
|Responsible Party:||Moleculin Biotech, Inc.|
|Other Study ID Numbers:||
|First Posted:||May 14, 2021 Key Record Dates|
|Last Update Posted:||February 10, 2023|
|Last Verified:||February 2023|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Respiratory Tract Neoplasms
Neoplasms by Site
Respiratory Tract Diseases