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CEP-9722 · 2 trials · 2 indications
To determine the maximum tolerated dose of CEP-9722, as defined by dose-limiting toxicities (DLTs) reported during the second 21-day treatment cycle (the first cycle of CEP-9722 administration).
| Arm | Type | Description |
|---|---|---|
| CEP-9722 in combination with Gemcitabine and Cisplatin | EXPERIMENTAL | Study drugs will be administered in cycles of 21 days for up to 6 cycles. CEP-9722 treatment will be initiated at cycle 2. After cycle 3, patients may discontinue gemcitabine and/or cisplatin for reasons of tolerability, at the discretion of the investigator. |
| 1 | EXPERIMENTAL | CEP-9722 alone and in combination therapy with temozolomide. |
| Name | Type | Description |
|---|---|---|
| CEP-9722 | DRUG | CEP-9722 will be administered orally from day 2 through day 7 of each cycle beginning with cycle 2. The starting dose will be 150 mg twice daily. Following cycle 2, the dose will either be decreased to 150 mg daily or increased to 200 mg twice daily in a cohort of 3 to 4 new patients. Subsequent cycles will increase the dose by 100 mg twice daily in cohorts of 3 to 4 patients (with criteria to expand to 6 patients) to a maximum of 400 mg twice daily. Patients must receive CEP-9722 to remain in the study. Once treatment with CEP-9722 is discontinued, patients will withdraw from the study. |
| Gemcitabine | DRUG | Gemcitabine will be administered at 1250 mg/m\^2 intravenously on day 1 and day 8 of each 21-day cycle. Dosage reduction may be applied on day 8 (within a cycle) or on day 1 of the next cycle based upon the grade of toxicity experienced by the patient. |
| Cisplatin | DRUG | Cisplatin will be administered at 75 mg/m\^2 intravenously on day 1 of each cycle, after the infusion of gemcitabine. Dosage reduction may be applied on day 1 of the next cycle based upon the grade of toxicity experienced by the patient. |
Inclusion Criteria: * Written informed consent is obtained. The patient has a either a histologically or cytologically confirmed malignant advanced solid tumor or a mantle cell lymphoma (and has experienced failure of as least 1 previous therapy) and the patient may benefit from the combination of ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 3 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
CEP-9722 is an investigational small molecule being developed by Teva Pharmaceutical Industries Limited for oncology. It has been studied in Phase 1 clinical trials in patients with advanced solid tumors and in patients with solid tumors or mantle cell lymphoma. It is not an approved therapy and remains in clinical development.
CEP-9722 has been studied in advanced solid tumors and in solid tumors or mantle cell lymphoma. Its Phase 1 trials evaluated it both as a single agent and in combination regimens, including with gemcitabine and cisplatin, and with temozolomide. It is investigational and has no approved indication.
CEP-9722 is being developed by Teva Pharmaceutical Industries Limited, which trades on the Nasdaq under the ticker TEVA. Teva is the sponsor of the clinical program evaluating the compound in advanced solid tumors and mantle cell lymphoma.
CEP-9722 is in Phase 1 clinical development. Both of its recorded Phase 1 studies have completed, and no active trials are currently listed. The program enrolled a total of 26 patients across its studies. CEP-9722 is investigational and has not been approved for any indication.
CEP-9722 has been evaluated in two completed Phase 1 trials. NCT01345357 studied CEP-9722 with gemcitabine and cisplatin in patients with advanced solid tumors or mantle cell lymphoma in Belgium and France. NCT00920595 studied CEP-9722 as a single agent and with temozolomide in advanced solid tumors in France and the United Kingdom.
The CEP-9722 clinical program enrolled 26 patients in total. NCT00920595, the single-agent and temozolomide combination study in advanced solid tumors, enrolled 26 patients. NCT01345357, the gemcitabine and cisplatin combination study in advanced solid tumors or mantle cell lymphoma, enrolled 24 patients.