Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Sapacitabine
Sapacitabine, Arm A · 2 trials · 1 indication
The distribution of overall survival was estimated by the method of Kaplan and Meier. A log-rank analysis stratified by randomization stratification factors was used to compare overall survival between Arm A (decitabine/sapacitabine) versus Arm C (decitabine). Cox proportional hazards models were used to identify predictive factors for overall survival.
Percentage of patients alive for one year measured from the date of randomization
| Arm | Type | Description |
|---|---|---|
| Sapacitabine-decitabine alternating | EXPERIMENTAL | Arm A sapacitabine administered in alternating cycles with decitabine |
| Decitabine | ACTIVE_COMPARATOR | Arm C Decitabine |
| A sapacitabine | EXPERIMENTAL | 200 mg b.i.d. x 7 days every 3-4 weeks |
| B sapacitabine | EXPERIMENTAL | 300 mg b.i.d. x 7 days every 3 - 4 weeks |
| C sapacitabine | EXPERIMENTAL | 400 mg b.i.d. x 3 days/week x 2 weeks every 3 - 4 weeks |
| D sapacitabine | EXPERIMENTAL | 200 mg b.i.d. x 7 consecutive days every 4 weeks |
| E sapacitabine | EXPERIMENTAL | 300 mg q.d. x 7 consecutive days every 4 weeks |
| F sapacitabine | EXPERIMENTAL | 300 mg b.i.d. x 3 consecutive days per week for 2 weeks every 4 weeks |
| G sapacitabine | EXPERIMENTAL | 200 mg b.i.d. x 7 consecutive days every 4 weeks |
| H sapacitabine | EXPERIMENTAL | 300 mg q.d. x 7 consecutive days every 4 weeks |
| I sapacitabine | EXPERIMENTAL | 100 mg q.d. x 5 consecutive days per week for 2 weeks every 4 weeks |
| Name | Type | Description |
|---|---|---|
| Sapacitabine | DRUG | Oral sapacitabine capsules |
| Decitabine | DRUG | Decitabine intravenous |
| Sapacitabine, Arm A | DRUG | 200 mg b.i.d. x 7 days every 3-4 weeks |
| Sapacitabine, Arm B | DRUG | 300 mg b.i.d. x 7 days every 3 - 4 weeks |
| Sapacitabine, Arm C | DRUG | 400 mg b.i.d. x 3 days/week x 2 weeks every 3 - 4 weeks |
| Sapacitabine, Arm D | DRUG | 200 mg b.i.d. x 7 consecutive days every 4 weeks |
| sapacitabine, Arm E | DRUG | 300 mg q.d. x 7 consecutive days every 4 weeks |
| sapacitabine, Arm F | DRUG | 300 mg b.i.d. x 3 consecutive days per week for 2 weeks every 4 weeks |
| Sapacitabine, Arm G | DRUG | 200 mg b.i.d. x 7 consecutive days every 4 weeks |
| Sapacitabine, Arm H | DRUG | 300 mg q.d. x 7 consecutive days every 4 weeks |
| Sapacitabine, Arm I | DRUG | 100 mg q.d. x 5 consecutive days per week for 2 weeks every 4 weeks |
Inclusion Criteria: * Newly diagnosed AML based on WHO (World Health Organization) classification * Age 70 years or older for whom the treatment of choice is low-intensity therapy by investigator assessment or who has refused intensive induction therapy recommended by investigator * ECOG (Eastern C...
Sapacitabine is an investigational small molecule being studied for the treatment of leukemias, acute myeloid leukemia, advanced solid tumors, and breast cancer. It is being developed by Cyclacel Pharmaceuticals, Inc. (CYCC) and is currently in Phase 1 clinical development.
Sapacitabine is a nucleoside analog that incorporates into DNA, leading to DNA damage and cell death. It is being studied in combination with other agents, such as olaparib, for the treatment of BRCA mutant breast cancer.
Sapacitabine is being developed by Cyclacel Pharmaceuticals, Inc., a biopharmaceutical company focused on oncology. The company's stock ticker is CYCC.
Sapacitabine is currently in Phase 1 clinical development. It has completed Phase 1 and Phase 2 trials in leukemias and acute myeloid leukemia, and is now being studied in a Phase 1 trial for advanced solid tumors and breast cancer.
Sapacitabine has been studied in several clinical trials, including NCT00380653 (Phase 1, advanced leukemias), NCT00590187 (Phase 2, acute myeloid leukemia), NCT00999401 (Phase 1, advanced solid tumors), and NCT03641755 (Phase 1, BRCA mutant breast cancer). The latter is currently active but not recruiting.
Sapacitabine is a distinct investigational drug and is not known to be the same as any other approved medication. It is being evaluated as a monotherapy and in combination with seliciclib and olaparib in clinical trials.