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Also known as BIIB021, Advanced Solid Tumors
CNF2024 · 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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CNF2024 is an investigational small molecule developed by Biogen Inc. (ticker BIIB) for oncology. It has been studied in Phase 1 clinical trials in patients with breast cancer and advanced solid tumors. It is not an approved therapy and remains in clinical development.
CNF2024 has been studied in Phase 1 research for breast cancer, including a pharmacokinetic and pharmacodynamic study in HER2-negative and HER2-positive patients. It has also been tested in advanced solid tumors and lymphoma. It is investigational and is not approved for any use.
CNF2024 is developed by Biogen Inc., which trades under the ticker BIIB. Biogen is the sponsor of the Phase 1 clinical program for this small molecule oncology candidate.
CNF2024 is in Phase 1 development. Its clinical trials in breast cancer and advanced solid tumors have been completed, and no active trials are currently listed. It is an investigational agent and has not been approved by the FDA.
CNF2024 has been evaluated in two completed Phase 1 trials. NCT00412412 studied CNF2024 in HER2-negative and HER2-positive breast cancer with pharmacokinetic and pharmacodynamic endpoints, enrolling 34 patients. NCT00345189 studied oral CNF2024 in advanced solid tumors and lymphoma across the United States and United Kingdom, enrolling 70 patients.
Yes, CNF2024 is also known as BIIB021. Both names refer to the same investigational small molecule from Biogen, and the clinical trial records for this compound list it under both designations.