15 and older, any sex, with Teratoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Progression Free Survival (PFS)Primary· At 24 months
Date of randomization to the date of the first documented progression or death due to any causeas per RECIST v1.1 (by local investigator assessment). Only includes data prior to cross over. Disease progression follow-up: Subjects who discontinued study drug for any reasons other than disease progression were followed for efficacy every 8 weeks during the first 12 months. After 12 months, they were followed for every 12 weeks until disease progression, death, discontinuation from the study for any other reason (i.e. loss to follow-up or withdrawal of consent), the initiation of a new antineopla
Group
Value
95% CI
LEE011
71.4
33.9 – 90.1
Placebo Arm
0.0
0.0 – 0.0
Best Overall Response (BOR)Secondary· At 24 months
as per RECIST v1.1. Only includes data prior to cross over. Placebo arm : the subject who experienced SD as best overall response entered the secondary phase and was treated with LEE011 after he experienced progressive disease, following his best Stable Disease response. In this outcome measure 2, only the best overall response is indicated.
Stable Disease (SD)
Group
Value
95% CI
LEE011
8
Placebo Arm
1
Progressive Disease (PD)
Group
Value
95% CI
LEE011
0
Placebo Arm
1
Overall Response RateSecondary· At 27 months
Overall response rate (ORR) = complete response (CR) or partial response (PR).
ORR was zero, as there were no CRs or PRs in either of the groups
Group
Value
95% CI
LEE011
0
0.0 – 36.9
Placebo Arm
0
0.0 – 84.2
Disease Control Rate (DCR)Secondary· At 24 months
as per RECIST v1.1. Only includes data prior to cross over. Placebo arm : the disease control rate is based on the best overall response described in the outcome measure 2.
Group
Value
95% CI
LEE011
100
63.1 – 100.0
Placebo Arm
50
1.3 – 98.7
Overall Survival (OS)Secondary· At 27 months
Only includes data prior to cross over. OS defined as the time from date of randomization to date of death due to any cause. If a patient was not known to have died by the date of analysis cut off, OS was censored at the date of last known date patient alive
as per RECIST v1.1. Only includes data prior to cross over. Kaplan-Meier estimates (%) OS rate \[95% CI\] at different timepoints. The overall survival rate at 27 month is 72.9% by Kaplan-Meyer (K-M) estimator; the reason that it is not 75% (1-25%) (Overall survival) is because of censoring. When the other 6 patients were censored would impact the survival rate with K-M method as the number of patients at risk after each censor was changed.
NA for the 95% CI is indicated when no patient died at the time of assessment, as the CI could not be calculated as per definition. Results are presented
1 month
Group
Value
95% CI
LEE011
100
NA – NA
Placebo Arm
100
NA – NA
2 months
Group
Value
95% CI
LEE011
100
NA – NA
Placebo Arm
100
NA – NA
3 months
Group
Value
95% CI
LEE011
100
NA – NA
Placebo Arm
100
NA – NA
6 months
Group
Value
95% CI
LEE011
100
NA – NA
Placebo Arm
100
NA – NA
9 months
Group
Value
95% CI
LEE011
100
NA – NA
Placebo Arm
100
NA – NA
12 months
Group
Value
95% CI
LEE011
87.5
38.7 – 98.1
Placebo Arm
100
NA – NA
15 months
Group
Value
95% CI
LEE011
87.5
38.7 – 98.1
Placebo Arm
100
NA – NA
18 months
Group
Value
95% CI
LEE011
87.5
38.7 – 98.1
Placebo Arm
100
NA – NA
All Collected DeathsSecondary· 12 months, 27 months
On treatment deaths are collected from first patient first visit up to 30 days after study treatment discontinuation (approximately 12 months, median duration of exposure). Patients with cancer are also followed up for overall survival until the end of the trial. During overall survival (up to 27 months after the first patient first visit), additional deaths were recorded, including deaths due to the cancer disease (having occurred more than 30 days after study drug discontinuation)
Total deaths
Group
Value
95% CI
LEE011
2
Placebo Arm
1
Deaths on treatment
Group
Value
95% CI
LEE011
0
Placebo Arm
0
Deaths post treatment survival follow up
Group
Value
95% CI
LEE011
2
Placebo Arm
1
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, as defined in the study protocol, for a median duration of exposure of 385 days..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This was a multi-center, randomized, double blind (investigator and subject), placebo controlled Phase II study to determine the efficacy and safety of treatment with ribociclib versus placebo in subjects with progressive relapsed, refractory incurable teratoma. Eligible subjects were randomized in a 2:1 ratio to ribociclib or placebo.
After discontinuation of study treatment, patients were followed up for safety, disease progression and overall survival.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
NCT03484923 — Study of Efficacy and Safety of Novel Spartalizumab Combinations in Patients With Previously Treated Unresectable or Met
· Phase 2
· completed
NCT02985125 — LEE011 Plus Everolimus in Patients With Metastatic Pancreatic Adenocarcinoma Refractory to Chemotherapy
· Phase 1, PHASE2
· completed
NCT03070301 — A Study of LEE011 With Everolimus in Patients With Advanced Neuroendocrine Tumors
· Phase 2
· completed
NCT02934568 — Ribociclib (LEE011) Rollover Study for Continued Access
· Phase 2
· active not recruiting
NCT02734615 — Phase I/Ib Trial of LSZ102 Single Agent or LSZ102 + LEE011 or LSZ102 + BYL719 in ER+ Breast Cancers
· Phase 1
· terminated
NCT02375204 — Standard-Dose Combination Chemotherapy or High-Dose Combination Chemotherapy and Stem Cell Transplant in Treating Patien
· Phase 3
· active not recruiting
NCT07498335 — Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary
· Phase 3
· not yet recruiting
NCT07489573 — Study of Efficacy and Safety of Secukinumab in Chinese Adult Patients With Moderate to Severe Hidradenitis Suppurativa
· Phase 4
· not yet recruiting
NCT07484269 — PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan
· not yet recruiting
NCT07416162 — A Study of Iptacopan in Korean Patients With Paroxysmal Nocturnal Hemoglobinuria or C3 Glomerulopathy
· not yet recruiting
NCT07387926 — Safety and Efficacy of Asciminib in Pediatrics and Young Adults With Relapse/Refractory (r/r) Philadelphia Positive (Ph+
· Phase 1, PHASE2
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
Last refreshed: 26 October 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02300987.