Advanced Solid TumorsPhase 1NCT01898845
A Phase I Study of LEE011 in Asian Patients
A Phase 1 study testing LEE011 in people with Advanced Solid Tumors, run by Novartis Pharmaceuticals at 2 sites in Japan.
Trial summary
This study will evaluate safety and tolerability to estimate the MTD and/or recommended dose for expansion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- LEE011
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 2 sitesJapan
- Study dates
- May 2013to Jan 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with a histologically confirmed diagnosis of a solid tumor
- ECOG PS <2
- Good organ function at screening visit
- A sufficient interval mast have elapsed between the last dose of prior anti-cancer therapy
Who cannot join
- Impairment of GI function
- Patients with concurrent severe and/or uncontrolled concurrent medical conditions
- Known diagnosis of HIV or active viral hepatitis
- Pregnant or nursing (lactating) women
Trial locations and contacts
2 sites in 1 country.
Japan2 sites
Novartis Investigative Site
Chuo-ku, Tokyo
Novartis Investigative Site
Kashiwa, Chiba
About this study
Official title: A Phase I Study of LEE011 in Asian Patients With Advanced Solid Tumors
This study will evaluate safety and tolerability to estimate the MTD and/or recommended dose for expansion.
Read the detailed description
This is a multi-center, open label, dose finding, phase I study of oral single agent LEE011, administered once daily.
- Conditions
- Advanced Solid Tumors
- Being tested
- LEE011
- Keywords
- Neoplasms
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LEE011Drug
| Study group | Role | What they receive |
|---|---|---|
| LEE011 | Experimental | LEE011 Receives: Drug: LEE011 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose limiting toxicities (DLTs)
Measured: First cycle (28 days)
Maximum tolerated dose (MTD) and/or recomended dose (RD)
Measured: First cycle (28 days)
Secondary outcomes (8)
Safety and Tolerability of LEE011
Assessed by incidence, duration and severity of adverse events and serious adverse events; changes in clinical laboratory values, vital signs and ECGs; tolerability of study drug (dose interruption, dose reduction)
Measured: from informed consent till 28 days after end of treatment
PK parameters of LEE011
Concentration of LEE011 and PK parameters (e.g. Cmax and AUC)
Measured: every week up to first 4 weeks, once a week in the subsequent 2 weeks
Best overall response
To assess preliminaly anti-tumor activity based on RECIST
Measured: every 2 months until 28 days after end of treatment
Overall response rate
To assess preliminaly anti-tumor activity based on RECIST
Measured: every 2 months until 28 days after end of treatment
Progression-free survival
To assess preliminaly anti-tumor activity based on RECIST
Measured: every 2 months until 28 days after end of treatment
Disease control rate
To assess preliminaly anti-tumor activity based on RECIST
Measured: every 2 months until 28 days after end of treatment
Duration of response
To assess preliminaly anti-tumor activity based on RECIST
Measured: every 2 months until 28 days after end of treatment
Overall response
To assess preliminaly anti-tumor activity based on RECIST
Measured: every 2 months until 28 days after end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2013 (estimated)
- Study startMay 2013
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Advanced Solid TumorsStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01898845
- Sponsor's protocol ID
- CLEE011X1101
- Status last verified
- Jul 2018
- First submitted
- 1 Jul 2013
- Last updated
- 19 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Doi T, Hewes B, Kakizume T, Tajima T, Ishikawa N, Yamada Y. Phase I study of single-agent ribociclib in Japanese patients with advanced solid tumors. Cancer Sci. 2018 Jan;109(1):193-198. doi: 10.1111/cas.13428. Epub 2017 Nov 12.
PubMed 29059492Ji Y, Wang C, Combes FP, Ho YY, Fasching PA, Untch M, Zarate JP, Crown J. Quantitative Pharmacology Justifying Ribociclib Dose in Early Breast Cancer. Clin Pharmacokinet. 2026 Aug;65(8):1217-1228. doi: 10.1007/s40262-026-01643-3. Epub 2026 Jun 23.
PubMed 42334791Ji Y, Yartsev V, Quinlan M, Serra P, Wang Y, Chakraborty A, Miller M. Justifying Ribociclib Dose in Patients with Advanced Breast Cancer with Renal Impairment Based on PK, Safety, and Efficacy Data: An Innovative Approach Integrating Data from a Dedicated Renal Impairment Study and Oncology Clinical Trials. Clin Pharmacokinet. 2023 Mar;62(3):493-504. doi: 10.1007/s40262-022-01206-2. Epub 2023 Feb 17.
PubMed 36800111
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of LEE011 in Asian Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT01898845
- Acronym / sponsor ID
- CLEE011X1101
- Conditions
- Advanced Solid Tumors
- Keywords
- Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 12 Jul 2013 (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 will evaluate safety and tolerability to estimate the MTD and/or recommended dose for expansion.
Detailed description
This is a multi-center, open label, dose finding, phase I study of oral single agent LEE011, administered once daily.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LEE011 | Experimental | Drug: LEE011LEE011 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient with a histologically confirmed diagnosis of a solid tumor
- ECOG PS <2
- Good organ function at screening visit
- A sufficient interval mast have elapsed between the last dose of prior anti-cancer therapy
Key exclusion criteria (4 listed)
- Impairment of GI function
- Patients with concurrent severe and/or uncontrolled concurrent medical conditions
- Known diagnosis of HIV or active viral hepatitis
- Pregnant or nursing (lactating) women
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 |
|---|---|---|
| LEE011 | Drug | LEE011 |
Primary outcome
Incidence of dose limiting toxicities (DLTs)
Time frame: First cycle (28 days)
Maximum tolerated dose (MTD) and/or recomended dose (RD)
Time frame: First cycle (28 days)
8 secondary outcomes
Safety and Tolerability of LEE011
Time frame: from informed consent till 28 days after end of treatment
PK parameters of LEE011
Time frame: every week up to first 4 weeks, once a week in the subsequent 2 weeks
Best overall response
Time frame: every 2 months until 28 days after end of treatment
Overall response rate
Time frame: every 2 months until 28 days after end of treatment
Progression-free survival
Time frame: every 2 months until 28 days after end of treatment
Disease control rate
Time frame: every 2 months until 28 days after end of treatment
Duration of response
Time frame: every 2 months until 28 days after end of treatment
Overall response
Time frame: every 2 months until 28 days after end of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2020.
- Results publication: PubMed 29059492Doi T, Hewes B, Kakizume T, Tajima T, Ishikawa N, Yamada Y. Phase I study of single-agent ribociclib in Japanese patients with advanced solid tumors. Cancer Sci. 2018 Jan;109(1):193-198. doi: 10.1111/cas.13428. Epub 2017 Nov 12.
- Derived from this study: PubMed 42334791Ji Y, Wang C, Combes FP, Ho YY, Fasching PA, Untch M, Zarate JP, Crown J. Quantitative Pharmacology Justifying Ribociclib Dose in Early Breast Cancer. Clin Pharmacokinet. 2026 Aug;65(8):1217-1228. doi: 10.1007/s40262-026-01643-3. Epub 2026 Jun 23.
- Derived from this study: PubMed 36800111Ji Y, Yartsev V, Quinlan M, Serra P, Wang Y, Chakraborty A, Miller M. Justifying Ribociclib Dose in Patients with Advanced Breast Cancer with Renal Impairment Based on PK, Safety, and Efficacy Data: An Innovative Approach Integrating Data from a Dedicated Renal Impairment Study and Oncology Clinical Trials. Clin Pharmacokinet. 2023 Mar;62(3):493-504. doi: 10.1007/s40262-022-01206-2. Epub 2023 Feb 17.
- Results for CLEE011X1101 can be found on the Novartis Clinical Trial Results WebsiteLink provided by the sponsor.
Related trials for Advanced Solid Tumors
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
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RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LEE011 in people with Advanced Solid Tumors, run by Novartis Pharmaceuticals at 2 sites in Japan.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 19 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Japan. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of dose limiting toxicities (DLTs) (time frame: First cycle (28 days)). 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?
On the ClinicalTrials.gov record for NCT01898845, which also lists 3 linked publications.
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 19 Dec 2020.