50 Participants Needed

Continued Access to Ribociclib for Solid Cancers

Recruiting at 2 trial locations
NP
Overseen ByNovartis Pharmaceuticals
Age: Any Age
Sex: Any
Trial Phase: Phase 2
Sponsor: Novartis Pharmaceuticals
Must be taking: Ribociclib
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

This study is to allow continued use of ribociclib (LEE011) as single agent or in combination with other investigational treatments in patients benefitting from treatment in an eligible Novartis-sponsored ribociclib (LEE011) study that has reached its primary objective(s) or has been halted for other reasons.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It seems focused on continuing ribociclib treatment for those already benefiting from it.

How does the drug ribociclib differ from other treatments for solid cancers?

Ribociclib is unique because it is a targeted therapy that works by inhibiting specific proteins (CDK4/6) involved in cell division, which can slow down or stop the growth of cancer cells. This mechanism is different from traditional chemotherapy, which generally targets all rapidly dividing cells.12345

Eligibility Criteria

This trial is for patients already participating in a Novartis-sponsored study using ribociclib (LEE011) alone or with other experimental treatments. They must be seeing positive results as judged by their doctor, and meet the original study's ongoing criteria.

Inclusion Criteria

I am currently in a Novartis study and taking ribociclib alone or with other treatments.
Patient is currently deriving clinical benefit from the study treatment, as determined by the investigator

Exclusion Criteria

I was taken off ribociclib treatment for any reason.
Patients who do not meet parent protocol criteria to continue study treatment

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Continued use of ribociclib (LEE011) as a single agent or in combination with other investigational treatments

up to 5 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension

Participants continue to receive ribociclib (LEE011) as long as they benefit from the treatment

up to 5 years

Treatment Details

Interventions

  • Ribociclib (LEE011)
Trial Overview The trial provides continued access to ribociclib (LEE011), either on its own or combined with other investigational drugs, for those who have benefited from it in previous Novartis studies that are now complete or stopped.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: LEE011Experimental Treatment1 Intervention
All patients in all combinations with LEE011 will be entered in one arm.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals

Lead Sponsor

Trials
2,963
Recruited
4,275,000+
Founded
1996
Headquarters
Basel, Switzerland
Known For
Precision medicine
Top Products
Gleevec, Cosentyx, Entresto, Kisqali
Dr. Vas Narasimhan profile image

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye profile image

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD

Findings from Research

The combination of ribociclib (LEE011) and irinotecan (SN38) showed a synergistic effect in inhibiting the growth of HT-29 colorectal cancer cells, which have a specific mutation, while it had an antagonistic effect on SW480 cells with a different mutation, indicating that the effectiveness of this combination therapy can vary based on the genetic profile of the cancer cells.
LEE011 was found to induce G1 cell cycle arrest by inhibiting retinoblastoma protein (Rb) phosphorylation, which contributed to its enhanced antiproliferative effect when combined with SN38 in HT-29 cells, highlighting the importance of understanding the molecular mechanisms behind drug interactions in cancer treatment.
Synergistic and Antagonistic Antiproliferative Effects of Ribociclib (Lee011) and Irinotecan (SN38) on Colorectal Cancer Cells.Huang, CI., Huang, YK., Lee, HM., et al.[2023]
Bosutinib, a Src/Abl kinase inhibitor, was generally well tolerated in patients with advanced solid tumors, with the recommended phase II dose (RP2D) established at 400 mg/day due to gastrointestinal toxicities observed at higher doses.
While some patients experienced partial or complete responses, the primary efficacy endpoints for progression-free and overall survival were not met, indicating that further studies, particularly in combination therapies, are needed.
Phase I study of bosutinib, a src/abl tyrosine kinase inhibitor, administered to patients with advanced solid tumors.Daud, AI., Krishnamurthi, SS., Saleh, MN., et al.[2014]
In a study of 48 chemotherapy-naive men with metastatic castration-resistant prostate cancer (CRPC), dasatinib 100 mg once daily showed a favorable safety profile, with only 13% experiencing severe drug-related side effects.
The treatment demonstrated significant activity, with 44% of patients showing no disease progression at 12 weeks and notable reductions in bone turnover markers, suggesting it maintains efficacy similar to higher dosing schedules.
Once-daily dasatinib: expansion of phase II study evaluating safety and efficacy of dasatinib in patients with metastatic castration-resistant prostate cancer.Yu, EY., Massard, C., Gross, ME., et al.[2021]

References

Synergistic and Antagonistic Antiproliferative Effects of Ribociclib (Lee011) and Irinotecan (SN38) on Colorectal Cancer Cells. [2023]
Phase I study of bosutinib, a src/abl tyrosine kinase inhibitor, administered to patients with advanced solid tumors. [2014]
Once-daily dasatinib: expansion of phase II study evaluating safety and efficacy of dasatinib in patients with metastatic castration-resistant prostate cancer. [2021]
A phase I, dose-finding study of sunitinib in combination with irinotecan in patients with advanced solid tumours. [2021]
Phase I/II study of the WEE1 inhibitor adavosertib (AZD1775) in combination with carboplatin in children with advanced malignancies: Arm C of the AcSé-ESMART trial. [2023]