Roll-over Study to Allow Continued Access to Ribociclib

• Sponsor: Novartis Pharmaceuticals (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05161195
• Collaborator: (none)
• Enrollment: 137
• Locations: 6
• Arm: 1
• Anticipated Duration (Months): 67.4
• Patients Per Site: 22.8
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

This is an open-label, multi-center, roll-over study to evaluate the long term safety of ribociclib in combination with other drugs in participants who are participating in a Novartis sponsored global study, that has fulfilled requirements for its primary objective(s), and who in the opinion of the Investigator, would benefit from continued treatment.

Condition or Disease	Intervention/Treatment	Phase
Metastatic Breast Cancer	Drug: Ribociclib; Drug: Letrozole; Drug: Anastrozole; Drug: Goserelin; Drug: Tamoxifen; Drug: Fulvestrant	Phase 4

Detailed Description

The purpose of this study is to evaluate long-term safety and provide continued treatment to participants who are currently receiving ribociclib in combination with other drugs in a parent study, that has fulfilled requirements for its primary objective(s), and in the opinion of the Investigator, would benefit from continuing treatment at time of discontinuation from the parent study

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 137 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Post-trial Access Roll-over Study to Allow Access to Ribociclib (LEE011) for Patients Who Are on Ribociclib Treatment in Novartis-sponsored Study
• Actual Study Start Date: Jul 7, 2022
• Anticipated Primary Completion Date: Jan 19, 2028
• Anticipated Study Completion Date: Feb 16, 2028

Arms and Interventions

Arm

Intervention/Treatment

Other: Ribociclib All participants will receive ribociclib in combination with other drugs at the same dose/schedule as in the parent study.

Drug: Ribociclib; Participants continue ribociclib as was administered in their parent study; Drug: Letrozole; Participants continue ribociclib in combination with letrozole as was administered in their parent study; Drug: Anastrozole; Participants continue ribociclib in combination with anastrozole as was administered in their parent study; Drug: Goserelin; Participants continue ribociclib in combination with goserelin as was administered in their parent study; Drug: Tamoxifen; Participants continue ribociclib in combination with tamoxifen as was administered in their parent study; Drug: Fulvestrant; All participants continue ribociclib in combination with fulvestrant as was administered in their parent study

Outcome Measures

Primary Outcome Measures

1. Percentage of participants with treatment-emergent adverse events (AES) [From day of first dose of study medication to 30 days after last dose of study medication, up to 5 years]

   The percentage of participants with treatment-emergent adverse events will be summarized, including significant adverse events leading to discontinuation, and adverse events leading to dose adjustment

Secondary Outcome Measures

1. Clinical benefit rate [Up to 5 years]

   Percentage of participants with clinical benefit as assessed by the Investigator at scheduled study visits

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Key inclusion Criteria:

1. 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)

2. Must have been receiving treatment with ribociclib for at least 6 cycles in the parent study

3. Currently has evidence of clinical benefit as determined by the Investigator

Key exclusion Criteria:

1. Permanent discontinuation of ribociclib in the parent study

2. Currently has unresolved toxicities for which ribociclib dosing has been interrupted in the parent study 3. Local access to commercially available ribociclib and reimbursed

Other protocol-defined inclusion/exclusion criteria may apply at the end

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mid Florida Hematology and Oncology Center	Orange City	Florida	United States	32763
2	Summit Cancer Care	Savannah	Georgia	United States	31405
3	John D Archbold Memorial Hospital	Thomasville	Georgia	United States	31792
4	Millennium Research Clin Develop	Houston	Texas	United States	77090
5	Novartis Investigative Site	Gdansk		Poland	80 952
6	Novartis Investigative Site	Singapore		Singapore	119228

Sponsors and Collaborators

• Novartis Pharmaceuticals

Investigators

• Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novartis Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT05161195
• Other Study ID Numbers: CLEE011A2412B; 2021-005184-42
• First Posted: Dec 17, 2021
• Last Update Posted: Jul 26, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Novartis Pharmaceuticals: Roll-over Protocol; Ribociclib; HR-positive; HER2-negative; Breast Cancer; Ribociclib in combination with other drugs; LEE011
• Additional relevant MeSH terms: Breast Neoplasms; Tamoxifen; Letrozole; Fulvestrant; Anastrozole; Goserelin

Study Results

No Results Posted as of Jul 26, 2022