Approval Probability
TA Base Rate
Adjusted LOA
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BIIB021 · 4 trials · 3 indications
| Arm | Type | Description |
|---|---|---|
| BIIB021 BID + exemestane | EXPERIMENTAL | BIIB021 100 mg BID + exemestane 25 mg QD |
| BIIB021 TIW + exemestane | EXPERIMENTAL | BIIB021 450 mg TIW + exemestane 25 mg QD |
| 1 | EXPERIMENTAL | BIIB021 |
| BIIB021 and Food | EXPERIMENTAL | The food phase will assess the effect of a high fat meal on the pharmacokinetics of BIIB021. |
| BIIB021 and Antacid | EXPERIMENTAL | Antacid phase will assess the effect of an antacid on the pharmacokinetics of BIIB021. |
| 2 | EXPERIMENTAL | Subjects in Schedule B will take BIIB021 in the morning at approximately 0800 with at least 6 ounces of water following an overnight fast (beginning at midnight). The second dose will be taken, following at least a 2-hour fast, 12 hours (+/- 2 hours) after the first dose, except on Day 1 of Cycle 1 and Day 1 of Cycle 2. |
| Name | Type | Description |
|---|---|---|
| BIIB021 | DRUG | BID orally for 28 days |
| exemestane (Aromasin) | DRUG | Daily in tablet form for 28 days |
| BIIB021 and Food | DRUG | Assessing the effect of food use on BIIB021 |
| BIIB0121 and Antacid | DRUG | Assessing the effect of antacid use on BIIB021 |
Inclusion Criteria: * Age 18 years of age * Must have histologically or cytologically confirmed estrogen receptor- positive or progesterone receptor-positive, incurable, locally advanced, or metastatic breast cancer. * Must have disease progression during treatment with a nonsteroidal AI for locall...
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BIIB021 is an investigational small molecule being studied for the treatment of breast cancer, gastrointestinal stromal tumors (GIST), and advanced solid tumors. It is developed by Biogen Inc. and has been evaluated in clinical trials for these oncology indications.
BIIB021 is developed by Biogen Inc., a biotechnology company traded on the NASDAQ under the ticker symbol BIIB. The drug has been studied in clinical trials for oncology indications including breast cancer, GIST, and advanced solid tumors.
BIIB021 is an investigational drug that has completed Phase 1 and Phase 2 clinical trials. It is not FDA approved and remains in clinical development. The trials have been completed, with no active trials currently ongoing for this asset.
BIIB021 has been studied in four completed clinical trials. These include NCT00618319 for GIST, NCT00618735 for advanced solid tumors, NCT01004081 for hormone receptor positive metastatic breast cancer, and NCT01017198 for advanced solid tumors. The trials were conducted in the United States and other countries.
BIIB021 is the investigational name for this small molecule developed by Biogen Inc. No alternative names have been reported for this compound in the available clinical trial information.