In short
Clinical trials are studying Annamycin in people with cancer, including acute myeloid leukemia and metastatic soft-tissue sarcomas. These studies look at safety, tolerability, dose selection, and early signs of benefit in adults with relapsed, refractory, or previously treated disease.
Key points
- Clinical trials of Annamycin in the source data focus on cancer, especially acute myeloid leukemia and metastatic soft-tissue sarcomas. The studies include adults with relapsed, refractory, or previously treated disease. Trial phases range from Phase 1 and Phase 1b/2 to a larger Phase 2/3 study, with one AML study listed as Phase 4 in the source data. The main goals are to check safety, tolerability, dose selection, complete remission, and progression-free survival. Some trials test Annamycin with cytarabine, while one sarcoma study looks at liposomal Annamycin alone.
Overview of the studies
The source data includes three interventional trials of Annamycin, also called liposomal Annamycin or L-Annamycin in the trial titles and summaries. These studies are in adults with cancer and focus on two main diseases: acute myeloid leukemia and metastatic soft-tissue sarcomas.
The trials are designed to learn about safety, tolerability, dose selection, and early signs of benefit. Two studies use Annamycin with cytarabine, which is another cancer drug named in the source data, and one study tests liposomal Annamycin alone in sarcoma.
Studies in acute myeloid leukemia
Two trials in the source data study acute myeloid leukemia (AML). One is a Phase 2/3 multi-center study in adults with refractory or relapsed AML, meaning the disease did not respond to treatment or came back after treatment. The other is a Phase 1 study that evaluates safety, efficacy, and tolerability of liposomal Annamycin with cytarabine in patients with AML.
The larger AML study compares L-Annamycin plus cytarabine with placebo plus cytarabine as second-line therapy, which means treatment given after the first treatment did not work well enough. Its Part A looks for the best dose regimen, and Part B tests whether the chosen dose works better than placebo when both are given with cytarabine.
The Phase 1 AML study also includes patients who are refractory to or relapsed after induction therapy, and the brief summary says it also considers first-line therapy in the source data. This trial aims to find the maximum tolerated dose and the Recommended Phase 2 Dose, which are study terms for choosing a dose that is workable and can be tested further.
Study in metastatic soft-tissue sarcoma
The sarcoma trial is a Phase 1b/2 study in patients with metastatic soft-tissue sarcomas after failure of at least one systemic therapy. Systemic therapy means treatment that travels through the body, such as treatment given by vein or by mouth, although the source data does not list all prior treatments.
This study tests weekly liposomal Annamycin as monotherapy, which means it is given by itself rather than with another anticancer drug. The Phase Ib part is designed to establish safety and tolerability and to determine the Recommended Phase 2 Dose. The Phase II part measures 3-month progression-free survival, a way to see whether the cancer stays from getting worse for at least three months.
What the trials measure
The main outcomes in these studies are different, but they all help researchers judge whether the treatment is promising. In the sarcoma study, the key outcomes are safety, tolerability, dose choice, and 3-month progression-free survival. In the AML studies, the trials measure complete remission, dose selection, and in one study whether the patient may be eligible for hematopoietic stem cell transplantation.
The AML Phase 1 study gives a detailed definition of complete remission in the source data: normal bone marrow appearance with fewer than 5% blasts, plus recovery of blood counts. It also defines complete remission with incomplete recovery as CR with incomplete recovery of platelets and/or neutrophils, and partial response as a 50% or greater decrease in marrow blasts.
The Phase 2/3 AML study uses the rate of CR after one treatment cycle as its main outcome, measured about 35 days plus or minus 14 days after treatment starts. This kind of endpoint helps show how many people respond after the first cycle of treatment.
Who may join these trials
The source data shows that the trials are for adult subjects with specific cancers. The AML studies include adults with refractory or relapsed AML, while the sarcoma study includes patients with metastatic soft-tissue sarcomas after at least one prior systemic therapy.
These are not general cancer studies for all patients. Each trial focuses on a specific disease group and treatment history, so people need to match the study rules listed in the trial data.
Trial phases and study size
The trials cover early and later research stages. The sarcoma study is Phase 1b/2 with 30 planned participants, the Phase 1 AML study has 24 participants, and the Phase 2/3 AML study plans 312 participants.
The source data also lists the Phase 2/3 AML study as Phase 4 in the phase field, so the trial record contains a phase label that does not fully match the title. In patient-friendly terms, this means the study record should be read carefully because different parts of the source data do not use the same phase label.
Important terms explained
Liposomal means the drug is placed in a tiny fat-like carrier, which is how the trial names describe Annamycin in these studies. Monotherapy means one drug is used by itself.
Second-line therapy means treatment used after the first treatment does not work well enough or the disease returns. Stem cell transplantation is a treatment approach mentioned in the Phase 1 AML study as an eligibility outcome, meaning the study checks whether a subject is fit enough for that next step of care.
Interventional means the researchers give a treatment and then measure the results. Authorised and completed are study status labels in the source data that show whether a trial is open for use or already finished.