Continued Access to Study Treatment(s), Cancers With a Mass, Bulky Tumor, Nodule, Lump, Advanced Cancer, Advanced Solid Tumors, Advanced Solid MalignanciesPhase 2NCT02934568
Ribociclib (LEE011) Rollover Study for Continued Access
A Phase 2 study testing LEE011 in people with Continued Access to Study Treatment(s), Cancers With a Mass, Bulky Tumor, Nodule, Lump, Advanced Cancer, Advanced Solid Tumors, Advanced Solid Malignancies, run by Novartis Pharmaceuticals at 13 sites in 6 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 0 to 80 years
- Conditions the study is for
- Continued Access to Study Treatment(s), Cancers With a Mass, Bulky Tumor, Nodule, Lump, Advanced Cancer, Advanced Solid Tumors, Advanced Solid Malignancies
- What is being tested?
- LEE011
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 13 sitesin 6 countries
- Study dates
- 15 Dec 2016to 1 Feb 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient is currently enrolled in an eligible Novartis-sponsored study and receiving ribociclib (LEE011) as single agent or in combination with other investigational treatment.
- Patient is currently deriving clinical benefit from the study treatment, as determined by the investigator.
Who cannot join
- Patient has been permanently discontinued from ribociclib (LEE011) in the parent protocol for any reason.
- Patients who do not meet parent protocol criteria to continue study treatment.
Trial locations and contacts
13 sites in 6 countries.
13 sites in 6 countries
United States5 sites
The Regents of the Uni of Michigan
Ann Arbor, Michigan, 48109-5930
University Of Alabama At Birmingham
Birmingham, Alabama, 35294-3300
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Broome Oncology
Johnson City, New York, 13790
St Jude Childrens Research Hospital
Memphis, Tennessee, 38105
France2 sites
Novartis Investigative Site
Lyon, 69373
Novartis Investigative Site
Villejuif, 94800
Spain2 sites
Novartis Investigative Site
Madrid, 28041
Novartis Investigative Site
Madrid, 28050
Taiwan2 sites
Novartis Investigative Site
Tainan, 704302
Novartis Investigative Site
Taipei, 10002
Germany1 site
Novartis Investigative Site
Cologne, North Rhine-Westphalia, 50937
About this study
Official title: An Open-label, Multi-center Rollover Protocol for Patients Who Have Participated in a Novartis-sponsored Ribociclib (LEE011) Study and Are Continuing to Benefit From Ribociclib as Single Agent or in Combination With Other Investigational Treatments
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.
- Being tested
- LEE011
- Keywords
- Ribociclib, LEE011
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LEE011Drug
Single agent LEE011 or in combination with other treatments
| Study group | Role | What they receive |
|---|---|---|
| LEE011 | Experimental | All patients in all combinations with LEE011 will be entered in one arm. Receives: Drug: LEE011 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients enrolled and received LEE011
Continued access to study treatment as a single agent or in combination with other investigational treatments until patients discontinue study
Measured: up to 5 years (study duration)
Length of time receiving study treatment
Assessed by duration in days from start of study treatment until study treatment discontinuation
Measured: up to 5 years (study duration)
Secondary outcomes (1)
Frequency and nature of adverse events (AEs), serious adverse events (SAEs), non-fatal SAEs and liver function assays.
The data include only AEs that started or worsened during the on-treatment-period, the treatment-emergent AEs.
Measured: up to 5 years (study duration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2016 (estimated)
- Study start15 Dec 2016
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Continued Access to Study Treatment(s), Cancers With a Mass, Bulky Tumor, Nodule, Lump, Advanced Cancer, Advanced Solid Tumors, Advanced Solid MalignanciesStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02934568
- Sponsor's protocol ID
- CLEE011X2X01B
- Status last verified
- Apr 2026
- First submitted
- 10 Oct 2016
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multi-center Rollover Protocol for Patients Who Have Participated in a Novartis-sponsored Ribociclib (LEE011) Study and Are Continuing to Benefit From Ribociclib as Single Agent or in Combination With Other Investigational Treatments
- ClinicalTrials.gov ID
- NCT02934568
- Acronym / sponsor ID
- CLEE011X2X01B
- Keywords
- Ribociclib, LEE011
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 15 Dec 2016 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 17 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LEE011 | Experimental | Drug: LEE011All patients in all combinations with LEE011 will be entered in one arm. |
Who may qualify
- Ages
- 0 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patient is currently enrolled in an eligible Novartis-sponsored study and receiving ribociclib (LEE011) as single agent or in combination with other investigational treatment.
- Patient is currently deriving clinical benefit from the study treatment, as determined by the investigator.
Key exclusion criteria (2 listed)
- Patient has been permanently discontinued from ribociclib (LEE011) in the parent protocol for any reason.
- Patients who do not meet parent protocol criteria to continue study treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LEE011Single agent LEE011 or in combination with other treatments | Drug | LEE011 |
Primary outcome
Number of Patients enrolled and received LEE011
Time frame: up to 5 years (study duration)
Continued access to study treatment as a single agent or in combination with other investigational treatments until patients discontinue study
Length of time receiving study treatment
Time frame: up to 5 years (study duration)
Assessed by duration in days from start of study treatment until study treatment discontinuation
1 secondary outcome
Frequency and nature of adverse events (AEs), serious adverse events (SAEs), non-fatal SAEs and liver function assays.
Time frame: up to 5 years (study duration)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Individual participant dataSharing planned: Undecided. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LEE011 in people with Continued Access to Study Treatment(s), Cancers With a Mass, Bulky Tumor, Nodule, Lump, Advanced Cancer, Advanced Solid Tumors, Advanced Solid Malignancies, run by Novartis Pharmaceuticals at 13 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, France, Spain, Taiwan, Germany and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients enrolled and received LEE011 (time frame: up to 5 years (study duration)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.