Calsed (amrubicin)

P3, N=509, Active, not recruiting, Amgen | Recruiting --> Active, not recruiting

P3, N=468, Recruiting, Daiichi Sankyo | Not yet recruiting --> Recruiting

P3, N=468, Not yet recruiting, Daiichi Sankyo | Trial completion date: Jan 2028 --> Feb 2029 | Trial primary completion date: Jul 2026 --> Apr 2027

P3, N=490, Recruiting, Amgen | N=700 --> 490 | Trial primary completion date: Sep 2025 --> Aug 2027

P3, N=468, Not yet recruiting, Daiichi Sankyo, Inc.

To address this issue, a study was conducted to investigate the potential of using amrubicin (AMR) encapsulated in poly (lactic-co-glycolic acid) nanoparticles (AMR-PLGA-NPs) against temozolomide (TMZ) resistant GBM. These findings indicate that AMR-PLGA-NPs can be an effective and flexible nanoplatform for treating GBM while addressing drug resistance issues. Overall, the study demonstrates the potential of AMR-PLGA-NPs as a stable and safe treatment option for GBM, addressing the major issue of drug resistance in these types of tumors. .

P3, N=700, Recruiting, Amgen | Trial primary completion date: Nov 2024 --> Sep 2025

Prospective and retrospective studies demonstrated that treatment outcome of second-line therapy using platinum with etoposide or docetaxel was unfavorable and progression-free survival was 3 months or shorter. Amrubicin and irinotecan were also frequently used as second-line therapy, however, efficacy of these agents was modest and response duration was less than 6 months...With the increasing recognition and active biopsy of NEPC lesions, the number of NEPC patients is anticipated to rise. Accumulating more knowledge and experience is crucial in developing novel treatment strategies to combat this disease.

Treatment with AMR between 30 and 35 mg/m showed relatively mild hematologic toxicity compared with AMR at 40 mg/m, without any significant difference in efficacy. Lower dose of AMR for relapsed SCLC could be a promising treatment option.

P3, N=700, Recruiting, Amgen | Not yet recruiting --> Recruiting

In AMR therapy for patients with relapsed SCLC, continuation of AMR without dose reduction after the second cycle may contribute to disease control and prolonged survival.

Patients will be randomized 1:1 to receive tarlatamab or SOC therapy (lurbinectedin or topotecan in US, Canada, Australia, Singapore, Korea; amrubicin in Japan; topotecan in all countries except Japan), stratified by prior anti-programmed cell death 1 (PD-1) or anti-programmed cell death ligand 1 (PD-L1) exposure, chemotherapy-free interval, presence of brain metastases, and SOC (topotecan/amrubicin vs lurbinectedin). DOI:1200/JCO.22.02823. Clinical trial information: NCT05740566.

Nivolumab did not improve survival versus chemotherapy in relapsed SCLC. No new safety signals were seen. In exploratory analyses, select baseline characteristics were associated with improved OS for nivolumab.

This combination therapy might be a viable treatment for previously treated NSCLC patients without a driver oncogene mutation. Clinical trial information UMIN 000010582.

He had a history of thymic carcinoma, which had been treated with carboplatin in combination with either paclitaxel or amrubicin...Administration of tegafur/gimeracil/oteracil (TS-1) was initiated, which resulted in tumor size reduction and a partial response...The patient achieved and maintained complete remission for more than 20 months by a de novo APL-treatment regimen including all-trans retinoic acid, arsenic trioxide and tamibarotene. Moreover, the thymic carcinoma has remained stable. Although secondary malignancies of thymic carcinoma have been previously reported, therapy-related leukemia, especially tAPL, is very rare.

He was initially treated with carboplatin and etoposide therapy. Tumor enlargement recurred after 8 cycles, and the patient is being treated with palliative therapy. Amrubicin therapy may be effective in the treatment of small cell carcinoma of the prostate.

A 65-year-old man was treated with pembrolizumab as first-line therapy and achieved temporarily a stable disease with progression after six cycles of this agent. At that stage, a transbronchial biopsy showed small cell lung cancer, and he was found to have high serum concentrations of neuron-specific enolase despite concentrations of numerous tumor markers, including neuron-specific enolase, having been within normal limits at the time of presentation. The patient thereafter was treated as a small cell carcinoma patient using cisplatin plus irinotecan and amrubicin.

P2, N=25, Active, not recruiting, Wakayama Medical University | Recruiting --> Active, not recruiting | Trial completion date: Aug 2020 --> Dec 2020 | Trial primary completion date: Feb 2020 --> Dec 2020