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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...
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Amrubicin is an investigational small molecule being studied for the treatment of small cell lung cancer and advanced solid tumors. Clinical trials have evaluated it in patients with small cell lung cancer who have responded to prior therapy, as well as those with refractory or progressive disease.
Amrubicin is being developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker BMY. The company has sponsored multiple clinical trials of the drug in oncology.
Amrubicin is in Phase 1 clinical development. While earlier trials have been completed, including Phase 2 and Phase 3 studies, the drug remains investigational and has not been approved by regulatory authorities.
Amrubicin has been studied in four completed trials, including NCT00319969, NCT00375193, NCT00388960, and NCT00547651. These trials enrolled a total of 887 participants and evaluated the drug in small cell lung cancer across multiple countries.
No, Amrubicin is not the same as topotecan. One clinical trial, NCT00319969, directly compared Amrubicin with topotecan in patients with small cell lung cancer who had responded to prior therapy, indicating they are distinct treatments.
Amrubicin is a small molecule, but its specific molecular target has not been disclosed. Clinical development has focused on its use as a single agent and in combination with cisplatin for small cell lung cancer.