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Also known as amrubidin hydrochloride, Calsed, CNF3140
Amrubicin · 5 trials · 2 indications
The duration of making measurements during the first cycle is 21 days. All data relating to the primary outcome measure is collected during this time. There is an optional Extension Phase during which subjects can continue to receive additional 21-day cycles of amrubicin unless there is evidence of tumor progression or unacceptable toxicity. The duration of measurements depends on how long the subject continues on treatment.
The duration of making measurements during the first cycle is 21 days. All data relating to the primary outcome measure is collected during this time. There is an optional Extension Phase during which subjects can continue to receive additional 21-day cycles of amrubicin unless there is evidence of tumor progression or unacceptable toxicity. The duration of measurements depends on how long the subject continues on treatment.
The duration of making measurements during the first cycle is 21 days. All data relating to the primary outcome measure is collected during this time. There is an optional Extension Phase during which subjects can continue to receive additional 21-day cycles of amrubicin unless there is evidence of tumor progression or unacceptable toxicity. The duration of measurements depends on how long the subject continues on treatment.
| Arm | Type | Description |
|---|---|---|
| Amrubicin | EXPERIMENTAL | Amrubicin |
| Topotecan | ACTIVE_COMPARATOR | Topotecan |
| 1 | EXPERIMENTAL | Amrubicin 40mg/m\<2\> IV days 1, 2, 3 of each 21-day cycle until cycle 6 or no longer beneficial. |
| Amrubicin plus Cisplatin | EXPERIMENTAL | Amrubicin 40mg/m\<2\> IV days 1, 2, 3 plus cisplatin 60mg/m\<2\> IV day 1 of each 21-day cycle until disease progression. |
| Cisplatin plus etoposide | ACTIVE_COMPARATOR | Cisplatin 75mg/m\<2\> IV day 1 plus etoposide 100mg/m\<2\> IV day 1 and 200mg/m\<2\> orally days 2, 3 or etoposide 100mg/m\<2\> IV days 1, 2, 3 each 21-day cycle until disease progression. |
| 2 | ACTIVE_COMPARATOR | Topotecan 1.5mg/m\<2\> IV, days 1, 2, 3, 4, 5 of each 21-day cycle until disease progression. |
| Amrubicin 40mg/m^2 | EXPERIMENTAL | Amrubicin 40mg/m\^2 given as a 5 minute IV infusion on Days 1, 2 \& 3 of a 21 day cycle |
| Name | Type | Description |
|---|---|---|
| Amrubicin | DRUG | Amrubicin for injection is supplied as 50-mg vials. Patients will receive 40 mg/m2 amrubicin as a 5-minute infusion once daily for 3 consecutive days starting on Day 1 of a 21-day course |
| Topotecan | DRUG | Topotecan for injection is supplied as 4-mg vials. Patients will receive 1.5 mg/m2 as a 30-minute infusion once daily for 5 consecutive days starting on Day 1 of a 21-day course |
| Cisplatin | DRUG | Amrubicin 40mg/m\<2\> IV days 1, 2, 3 plus Cisplatin 60mg/m\<2\> day 1 of each 21-day cycle until disease progression. Cisplatin 75mg/m\<2\> IV day 1 plus etoposide 100mg/m\<2\> IV day 1 and 200mg/m\<2\> orally days 2, 3 or etoposide 100mg/m\<2\> IV days 1, 2, 3 of each 21-day cycle until disease progression. |
| Etoposide | DRUG | Cisplatin 75mg/m\<2\> IV day 1 plus etoposide 100mg/m\<2\> IV day 1 and 200mg/m\<2\> orally days 2, 3 or etoposide 100mg/m\<2\> IV days 1, 2, 3 of each 21-day cycle until disease progression. |
Inclusion Criteria: * Histological or cytological diagnosis of SCLC at study entry according to the International Association for the Study of Lung Cancer (IASLC) histopathologic classification. Mixed or combined subtypes according to the IASLC are not allowed; * SCLC that is either sensitive (defi...
Top 1 of 2 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Amgen Inc. | AMGN | 1 | PHASE3 | Tarlatamab |
Amrubicin is an investigational small molecule studied in oncology for advanced solid tumors and small cell lung cancer. It has been evaluated in small cell lung cancer after failure of first-line chemotherapy, in extensive stage disease in combination with cisplatin, and in patients whose disease was refractory or progressive after prior therapy.
Amrubicin targets TOP2A, topoisomerase II alpha, and acts as an inhibitor of this enzyme. TOP2A is involved in DNA replication and repair, and inhibiting it interferes with those processes in tumor cells. This target class places Amrubicin among topoisomerase II inhibitor small molecules.
Amrubicin is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company has sponsored the clinical program evaluating the drug in advanced solid tumors and small cell lung cancer.
Amrubicin is in Phase 1 development and is investigational. Its four recorded trials are all completed, with no active trials, and include Phase 1, Phase 2, and Phase 3 studies. The Phase 1 study assessed safety, pharmacokinetics, and potential effects on the QT/QTc interval in advanced solid tumors.
Amrubicin has been studied in four completed trials: NCT00915083 in advanced solid tumors, NCT00547651 in small cell lung cancer after first-line chemotherapy failure, NCT00388960 comparing Amrubicin with or without cisplatin versus etoposide-cisplatin in extensive stage small cell lung cancer, and NCT00375193 in refractory or progressive small cell lung cancer.
Across its four completed trials, Amrubicin has enrolled a total of 887 patients. Enrollment ranged from 24 patients in the Phase 1 advanced solid tumor study to 637 patients in the Phase 3 small cell lung cancer trial. All trials were uncontrolled and non-randomized.