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Also known as Ribociclib, LEE011, ribociclib, Ribociclib (neoadjuvant)
Ribociclib+ Letrozole OR Fulvestrant · 3 trials · 3 indications
using RECIST 1.1 criteria, as assessed by local radiologists/investigators
Progression free survival (PFS) is defined as the interval from the time of randomization until objective disease progression (local assessment) or death from any cause. Disease status will be assessed with comprehensive radiographic studies every three treatment cycles (approximately every 12 weeks (+/- 1 week)). Disease progression as assed by RECIST 1.1 defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
incidence of DLTs during the defined DLT period
| Arm | Type | Description |
|---|---|---|
| Ribociclib + Endocrine Therapy | EXPERIMENTAL | Ribociclib + Fulvestrant or Letrozole |
| Palbociclib + Endocrine Therapy | EXPERIMENTAL | Palbociclib + Fulvestrant or Letrozole |
| Paclitaxel +/- Tislelizumab - Exploratory cohort | EXPERIMENTAL | Additional experimental Cohort that includes patients with Basal-Like intrinsic subtype. |
| Ribociclib (LEE-011)/Fulvestrant | EXPERIMENTAL | LEE-011 is administered orally, 600mg, daily for 3 weeks and 1 week off. Fulvestrant is administered intramuscularly, 500mg, every 2 weeks x 3, then every 4 weeks. |
| Placebo/Fulvestrant | PLACEBO_COMPARATOR | Placebo is administered orally, 600mg daily for 3 weeks and 1 week off. Fulvestrant is administered intramuscularly, 500mg, every 2 weeks x 3, then every 4 weeks. |
| Cohort 1: Dose Escalation Cohort | EXPERIMENTAL | Ribociclib and belinostat will be given at escalating doses and on multiple administration schedules throughout the dose escalation component of the study. The MTD identified in the dose escalation component will be used to define the dose and administration schedule used in the dose expansion. |
| Cohort 2: Dose expansion cohort | EXPERIMENTAL | Participant will be enrolled in dose expansion cohort at the identified Recommended Phase 2 Dose (RP2D). Dose escalation will be open to the enrollment of patients diagnosed with triple-negative breast cancer or ovarian cancer. However, dose expansion will only be open to the enrollment of patients diagnosed with triple-negative breast cancer |
| Name | Type | Description |
|---|---|---|
| Ribociclib + Letrozole OR Fulvestrant | DRUG | Endocrine Therapy will be selected by the investigator. For premenopausal women and men: LHRH agonist once every 4 weeks |
| Palbociclib + Letrozole OR Fulvestrant | DRUG | Endocrine Therapy will be selected by the investigator. For premenopausal women and men: LHRH agonist once every 4 weeks |
| Paclitaxel +/- Tislelizumab | DRUG | Patients in this arm could receive as the first line of therapy |
| LEE-011 | DRUG | 600 mg capsule (3x 200 mg capsules) |
| Fulvestrant | DRUG | 500 mg injection |
| Placebo | DRUG | 600 mg capsule (3x 200 mg capsules) |
| Ribociclib | DRUG | Ribociclib Dose Level 0 (starting dose) 200mg QD Dose Level 1A 400mg QD on Days 8-28 Dose Level 1B 200mg QD Dose Level 2 400mg QD on Days 8-28 |
| Belinostat | DRUG | Belinostat Dose Level 0 (starting dose) 600mg/m2 daily for 5 days Dose Level 1A 600mg/m2 daily for 5 days Dose Level 1B 1000mg/m2 daily for 5 days Dose Level 2 1000mg/m2 daily for 5 days \*Administration on 5 consecutive days is preferred. Administration within 7 days allowed as needed to accommodate holidays and infusion schedules. |
Main Inclusion Criteria: * Histologically documented HR-positive and HER2-negative breast cancer by local testing * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. * advanced (loco regionally recurrent not amenable to curative therapy or metastatic) breast cancer. * Availabi...
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LEE011, also known as ribociclib, is an investigational small molecule being studied for multiple oncology indications, including early breast cancer, hormone receptor positive HER2-negative breast cancer, advanced breast cancer, and glioblastoma multiforme. It is currently in Phase 1 clinical development.
LEE011 (ribociclib) is a cyclin-dependent kinase (CDK) inhibitor, belonging to the -ciclib class of drugs that target CDK enzymes involved in cell cycle regulation. It is being evaluated for its role in treating various cancers, including breast cancer and glioblastoma multiforme.
LEE011 (ribociclib) is developed by Novartis AG, a global pharmaceutical company listed on the stock exchange under the ticker symbol NVS. The drug is being investigated in clinical trials for multiple cancer indications.
LEE011 (ribociclib) is currently in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug has received a rare pediatric disease designation from the FDA.
LEE011 (ribociclib) has been studied in 12 clinical trials with a total enrollment of 6,501 participants. Notable trials include NCT03701334, a Phase 3 study in early breast cancer with 5,101 patients, and NCT05827081, a Phase 3b study in early breast cancer currently recruiting.
Yes, LEE011 is also known as ribociclib. The drug is referred to by both names in clinical research, and it is being developed by Novartis AG for the treatment of various cancers, including breast cancer and glioblastoma multiforme.