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Also known as CNF2024
BIIB021 · 6 trials · 5 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. |
| A | EXPERIMENTAL | Patients with HER2- Breast Cancer |
| B | EXPERIMENTAL | Patients with HER2+ Breast Cancer |
| Dosing Schedule 1 | OTHER | Starting dose of 25 mg, with dosing twice a week for 3 weeks out of a 4-week course (Schedule 1). Dosing for schedule 1 is currently closed. |
| Dosing Schedule 2 | OTHER | Starting dose of 600 mg, with dosing twice a week for 4 weeks out of a 4-week course (without drug holidays; Schedule 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 |
| CNF2024 | DRUG | Oral doses of CNF2024 as specified in the protocol. |
| CNF2024 + trastuzumab | DRUG | Oral doses of CNF2024 as specified in the protocol Intravenous doses of trastuzumab as specified in the package insert. |
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 developed by Biogen Inc. (ticker BIIB) for oncology. It has been studied in advanced solid tumors, breast cancer, and gastrointestinal stromal tumors (GIST). It is a Phase 1 asset and has not been approved by the FDA; all listed trials are completed.
BIIB021 has been studied in advanced solid tumors, hormone receptor positive metastatic breast cancer, and gastrointestinal stromal tumors (GIST). It is an investigational agent and is not approved for any indication. All clinical trials of BIIB021 listed to date have been completed.
BIIB021 targets HSP90AA1 and HSP90AB1. It is an inhibitor of these heat shock protein 90 isoforms. By binding HSP90, BIIB021 interferes with the chaperone function that supports stability of client oncoproteins, which is the proposed basis for its evaluation in advanced solid tumors, breast cancer, and GIST.
BIIB021 is developed by Biogen Inc., which trades under the ticker BIIB. Biogen sponsored the clinical trials of BIIB021 in advanced solid tumors, hormone receptor positive metastatic breast cancer, and gastrointestinal stromal tumors (GIST).
BIIB021 is in Phase 1 development. It is investigational and has not been approved by the FDA. Its clinical program includes Phase 1 and Phase 2 trials, all of which are completed, with no active trials currently listed. The studies enrolled a total of 88 participants.
BIIB021 has been evaluated in completed trials including NCT01017198, which studied the effect of food and antacid in advanced solid tumors; NCT01004081, a Phase 2 study in hormone receptor positive metastatic breast cancer with Aromasin; NCT00618735, a Phase 1 once or twice daily dosing study in advanced solid tumors; and NCT00618319, a Phase 2 PET assessment in GIST.