Clinical Trials /

Study of Liposomal Annamycin for the Treatment of Subjects With Soft-Tissue Sarcomas (STS) With Pulmonary Metastases

NCT04887298

Description:

This is a multi-center, open-label, single-arm study that in Phase 1b will determine the maximum tolerated dose (MTD)/ recommended phase 2 dose (RP2D) and safety of L-Annamycin and in Phase 2 will explore the efficacy of L- Annamycin as a single agent for the treatment of subjects with STS with lung metastases for which chemotherapy is considered appropriate.

Related Conditions:
  • Soft Tissue Sarcoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Study of Liposomal Annamycin for the Treatment of Subjects With Soft-Tissue Sarcomas (STS) With Pulmonary Metastases
  • Official Title: Phase 1B/2 Study Of Liposomal Annamycin (L-Annamycin) In Subjects With Previously Treated Soft-Tissue Sarcomas With Pulmonary Metastases

Clinical Trial IDs

  • ORG STUDY ID: MB-107
  • NCT ID: NCT04887298

Conditions

  • Sarcoma,Soft Tissue
  • Pulmonary Metastasis

Interventions

DrugSynonymsArms
Liposomal Annamycin (L-Annamycin)Liposomal Annamycin (L-Annamycin)

Purpose

This is a multi-center, open-label, single-arm study that in Phase 1b will determine the maximum tolerated dose (MTD)/ recommended phase 2 dose (RP2D) and safety of L-Annamycin and in Phase 2 will explore the efficacy of L- Annamycin as a single agent for the treatment of subjects with STS with lung metastases for which chemotherapy is considered appropriate.

Trial Arms

NameTypeDescriptionInterventions
Liposomal Annamycin (L-Annamycin)Experimental
  • Liposomal Annamycin (L-Annamycin)

Eligibility Criteria

        Inclusion Criteria:

          1. The subject has a pathologically confirmed diagnosis of STS and documented lung
             metastases that are considered eligible for chemotherapy and not eligible for
             potentially curative surgical resection of pulmonary-only metastatic disease.

          2. The subject had prior anthracycline therapy (cumulative dose of ≤450 mg/m2) for their
             disease and has shown progression of disease prior to study entry.

          3. The subject must have measurable disease in the lung, defined as at a minimum, 1
             lesion that can be accurately measured in at least one dimension of >10 mm. Subjects
             with extra-pulmonary disease are eligible.

          4. The subject has an estimated life expectancy of greater than 3 months.

          5. The subject has an Eastern Cooperative Oncology Group (ECOG) performance status ≤2.

          6. The subject is ≥18 years old at the time of signing informed consent.

          7. At least 2 weeks must have passed following treatment for their disease with
             chemotherapy, investigational therapy, targeted agents, biological agents, immune
             modulators, or radiotherapy, and any toxicities must have resolved to ≤ grade 1 or
             previous baseline levels no more than 4 weeks after completing therapy (except
             alopecia and polyneuropathy).

          8. The subject must have adequate laboratory results including the following:

               1. Absolute neutrophil count ≥ 1500/mL and platelets ≥100,000/mL

               2. Hemoglobin ≥ 8.0 g/dL

               3. Adequate renal function (The Cockcroft-Gault equation will be used to estimate
                  creatinine clearance. This equation is as follows: Creatinine clearance in
                  milliliters per minute = [140-age] x body weight [kg]/72 x plasma creatinine
                  [mg/dL]; multiplied by 0.85 for women. By using this equation, adequate renal
                  function will be deemed to be a creatinine clearance of greater than 60
                  mL/minute)

               4. Bilirubin ≤1.5 x upper limit of normal (ULN) (unless due to Gilbert's syndrome)

               5. 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)

          9. 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.

         10. All subjects (men and women) agree to practice effective contraception during the
             entire study period and after discontinuing study drug, unless documentation of
             infertility exists.

               1. Sexually active, fertile women must 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

               2. Sexually active men and their sexual partners must use effective contraceptive
                  methods from the time of informed consent until at least 6 months after
                  discontinuing study drug

        Exclusion Criteria:

          1. The subject has any condition that, in the opinion of the Investigator, places the
             subject at unacceptable risk if they were to participate in the study.

          2. The subject has left ventricular ejection fraction (LVEF) <50%, valvular heart
             disease, or severe hypertension not controlled by medical therapy. Cardiac subjects
             with a New York Heart Association classification of 3 or 4 will be excluded, as will
             those with recent (≤ 6 months) myocardial infarction, unstable angina, or symptomatic
             congestive heart failure.

          3. The subject has a baseline QT/QTc interval >480 msec, a history of additional risk
             factors for torsade des pointes (e.g., heart failure, hypokalemia, family history of
             Long QT Syndrome) and use of concomitant medications that significantly prolong the
             QT/QTc interval.

          4. The subject has clinically relevant serious comorbid medical conditions including, but
             not limited to active infection, known positive status for human immunodeficiency
             virus or active hepatitis B or C, cirrhosis, or psychiatric illness/social situations
             that would limit compliance with study requirements.

          5. The subject is pregnant, lactating, or not using adequate contraception.

          6. The subject has a known allergy to study drug or excipients.

          7. 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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Dose Limiting Toxicity
Time Frame:21 days
Safety Issue:
Description:Number of patients with a dose limiting toxicity (DLT) at each dose evaluated

Secondary Outcome Measures

Measure:Efficacy of L-Annamycin
Time Frame:At the end of every other treatment cycle ( each cycle is 21 days)
Safety Issue:
Description:Determine preliminary efficacy of L-Annamycin as per revised Response Evaluation Criteria in Solid Tumors (RECIST) guidelines (version 1.1)
Measure:Area Under the Plasma Concentration Versus Time Curve (AUC) of L-Annamycin
Time Frame:Cycle 1 Day 1 ( each cycle is 21 days)
Safety Issue:
Description:Determine pharmacokinetics of L-Annamycin and its metabolite, annamycinol as measured by AUC

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Moleculin Biotech, Inc.

Last Updated

June 11, 2021