NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

Roll-over Study to Allow Continued Access to Ribociclib

Active Not RecruitingPhase 4

Sponsor: Novartis Pharmaceuticals

Conditions: Metastatic Breast Cancer

Interventions: Ribociclib, Letrozole, Anastrozole, Goserelin, Tamoxifen

Countries: United States, Argentina, Brazil, China, Costa Rica, Greece, Hong Kong, India

The purpose of this study is to assess the long-term safety of ribociclib (LEE011) in combination with other drugs and provide post-trial access (PTA) to participants who are currently receiving treatment with ribociclib in combination with other drugs and continuing to have clinical benefit in a Novartis-sponsored global study that has reached its primary objective(s).

Eligibility overview

Sex: ALL

Age: 18 Years to 100 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Key Inclusion Criteria:

* Signed informed consent must be obtained prior to participation in the study.
* Participant is currently participating in a Novartis sponsored global study (parent study), receiving treatment with ribociclib in combination with other drugs and the parent study has fulfilled its primary objective(s).
* Willingness and ability to comply with scheduled visits, treatment plans and any other study procedures.
* Participant must have been receiving treatment with ribociclib for at least 6 cycles in the parent study.
* Participant must have evidence of clinical benefit as determined by the Investigator.

Key Exclusion Criteria:

* Permanent discontinuation of ribociclib in the parent study due to toxicity or disease progression, non-compliance to study procedures, withdrawal of consent or any other reason as stipulated in parent protocol.
* Participant currently has unresolved toxicities for which ribociclib dosing has been interrupted in the parent study (participants meeting all other eligibility criteria may be enrolled once toxicities have resolved to allow ribociclib dosing to resume).
* Local access to commercially available ribociclib and reimbursed (except for US enrolled participants from parent protocol CLEE011A2404 meeting all other eligibility criteria).
* Women of child-bearing potential defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during the study treatment and for 21 days after stopping the treatment. Highly effective contraception methods include:

1. Total abstinence
2. Female sterilization
3. Male partner sterilization
4. Placement of an intrauterine device (IUD)
* Male contraception during ribociclib use by male participants is not required unless it is necessary due to the safety profile of other medications a participant is taking or by local regulations.

Other protocol-defined inclusion/exclusion criteria may apply.

Locations (73)

Chandler, Arizona, United States
Fayetteville, Arkansas, United States
Beverly Hills, California, United States
Fort Collins, Colorado, United States
Orange, Florida, United States
Savannah, Georgia, United States
Thomasville, Georgia, United States
Plainfield, Illinois, United States
Goshen, Indiana, United States
Portland, Maine, United States
Englewood, New Jersey, United States
Paramus, New Jersey, United States
The Bronx, New York, United States
Cleveland, Ohio, United States
Tulsa, Oklahoma, United States
Houston, Texas, United States
San Juan, Argentina
Natal, Rio Grande do Norte, Brazil
Ijuí, Rio Grande do Sul, Brazil
Florianópolis, Santa Catarina, Brazil
São Paulo, São Paulo, Brazil
São Paulo, São Paulo, Brazil
Sao Jose Rio Preto, Brazil
São Paulo, Brazil
Chongqing, Chongqing Municipality, China
Shijiazhuang, Hebei, China
Harbin, Heilongjiang, China
Changsha, Hunan, China
Nanjing, Jiangsu, China
Suzhou, Jiangsu, China
+ 43 more on CT.gov