NeoplasmsPhase 1NCT01968915
Safety and Tolerability of Oral LCL161 in Japanese Adult Patients With Advanced Solid Tumors
A Phase 1 study testing LCL161 and Paclitaxel in people with Neoplasms, run by Novartis Pharmaceuticals at 2 sites in Japan.
Trial summary
This study will evaluate safety and tolerability to estimate the maximum tolerated dose and/or recommended dose of oral LCL161 in Japanese patients with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- LCL161 and Paclitaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 2 sitesJapan
- Study dates
- Nov 2013to Jun 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
- Patients with a histologically or cytologically confirmed diagnosis of a solid tumor for which no further effective standard treatment is available.
- ECOG performance status 0-1.
- Patients must have recovered from all toxicities related to their previous treatment.
Who cannot join
- Unresolved nausea, vomiting, diarrhea or peripheral neuropathy CTCAE grade >1.
- History of or current interstitial lung disease or autoimmune disease.
- History of or current impaired cardiac function or clinically significant cardiac diseases.
- Women of child-bearing potential, unless they are using highly effective methods of contraception.
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
2 sites in 1 country.
Japan2 sites
Novartis Investigative Site
Kobe, Hyōgo, 650-0017
Novartis Investigative Site
Nagoya, Aichi-ken, 466-8560
About this study
Official title: A Phase I Study of Oral LCL161 in Japanese Adult Patients With Advanced Solid Tumors
This study will evaluate safety and tolerability to estimate the maximum tolerated dose and/or recommended dose of oral LCL161 in Japanese patients with advanced solid tumors.
- Conditions
- Neoplasms
- Being tested
- LCL161, Paclitaxel
- Keywords
- LCL161, Paclitaxel, Japanese patient, Neoplasms
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LCL161Drug
Patients will receive oral LCL161 once a week until unacceptable toxicity, disease progression and/or withdrawal of consent.
PaclitaxelDrug
Patients will receive weekly paclitaxel as intravenous infusion over 1 hour in combination with LCL161, from cycle 2 in dose escalation part or from the first cycle in dose expansion part, and will continue it until unacceptable toxicity, disease progression and/or withdrawal of consent.
| Study group | Role | What they receive |
|---|---|---|
| LCL161 | Experimental | Dose escalation part: Eligible patients will start to receive oral LCL161 once a week and will receive weekly paclitaxel, at 80 mg/m2 intravenous infusion over 1 hour, in combination with LCL161 from cycle 2. Dose expansion part: Eligible patients will receive oral LCL161 at the maximum tolerated dose and/or recommended dose in combination with weekly paclitaxel, at 80 mg/m2 intravenous infusion over 1 hour from cycle 1. Receives: Drug: LCL161; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of dose limiting toxicities as a function of LCL161 during first cycle
Measured: First cycle (21 days)
Adverse events of oral LCL161
Type and frequency of adverse events of oral LCL161 when administered in combination with weekly paclitaxel
Measured: From informed consent until 28 days after end of treatment (end of treatment visit occurs within 7 days after the determination of study discontinuation)
Secondary outcomes (4)
Adverse events of oral LCL161
Type and frequency of adverse events of oral LCL161
Measured: From informed consent until 28 days after end of treatment (end of treatment visit occurs within 7 days after the determination of study discontinuation)
LCL161 plasma concentration and derived pharmacokinetic parameters
Measured: From first cycle and up to 3 cycle (each cycle is 21-day period)
Paclitaxel plasma concentration and derived pharmacokinetic parameters
Measured: From first cycle of combination and up to 2 cycle (each cycle is 21-day period)
Tumor response according to RECIST 1.1
Measured: Every 2 cycles for first 8 cycles, then every 3 cycles and until end of treatment (each cycle is 21-day period and end of treatment visit occurs within 7 days after the determination of study discontinuation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2013 (estimated)
- Study startNov 2013
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies 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
- 9 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
- NCT01968915
- Sponsor's protocol ID
- CLCL161A1102
- Status last verified
- Jan 2016
- First submitted
- 21 Oct 2013
- Last updated
- 19 Dec 2020
- Results posted
- No
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 Oral LCL161 in Japanese Adult Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT01968915
- Acronym / sponsor ID
- CLCL161A1102
- Conditions
- Neoplasms
- Keywords
- LCL161, Paclitaxel, Japanese patient, Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 24 Oct 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 maximum tolerated dose and/or recommended dose of oral LCL161 in Japanese patients with advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LCL161 | Experimental | Drug: LCL161, Drug: PaclitaxelDose escalation part: Eligible patients will start to receive oral LCL161 once a week and will receive weekly paclitaxel, at 80 mg/m2 intravenous infusion over 1 hour, in combination with LCL161 from cycle 2. Dose expansion part: Eligible patients will receive oral LCL161 at the maximum tolerated dose and/or recommended dose in combination with weekly paclitaxel, at 80 mg/m2 intravenous infusion over 1 hour from cycle 1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with a histologically or cytologically confirmed diagnosis of a solid tumor for which no further effective standard treatment is available.
- ECOG performance status 0-1.
- Patients must have recovered from all toxicities related to their previous treatment.
Key exclusion criteria (5 listed)
- Unresolved nausea, vomiting, diarrhea or peripheral neuropathy CTCAE grade >1.
- History of or current interstitial lung disease or autoimmune disease.
- History of or current impaired cardiac function or clinically significant cardiac diseases.
- Women of child-bearing potential, unless they are using highly effective methods of contraception.
- Other protocol-defined inclusion/exclusion criteria may apply.
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 |
|---|---|---|
| LCL161Patients will receive oral LCL161 once a week until unacceptable toxicity, disease progression and/or withdrawal of consent. | Drug | LCL161 |
| PaclitaxelPatients will receive weekly paclitaxel as intravenous infusion over 1 hour in combination with LCL161, from cycle 2 in dose escalation part or from the first cycle in dose expansion part, and will continue it until unacceptable toxicity, disease progression and/or withdrawal of consent. | Drug | LCL161 |
Primary outcome
Frequency of dose limiting toxicities as a function of LCL161 during first cycle
Time frame: First cycle (21 days)
Adverse events of oral LCL161
Time frame: From informed consent until 28 days after end of treatment (end of treatment visit occurs within 7 days after the determination of study discontinuation)
Type and frequency of adverse events of oral LCL161 when administered in combination with weekly paclitaxel
4 secondary outcomes
Adverse events of oral LCL161
Time frame: From informed consent until 28 days after end of treatment (end of treatment visit occurs within 7 days after the determination of study discontinuation)
LCL161 plasma concentration and derived pharmacokinetic parameters
Time frame: From first cycle and up to 3 cycle (each cycle is 21-day period)
Paclitaxel plasma concentration and derived pharmacokinetic parameters
Time frame: From first cycle of combination and up to 2 cycle (each cycle is 21-day period)
Tumor response according to RECIST 1.1
Time frame: Every 2 cycles for first 8 cycles, then every 3 cycles and until end of treatment (each cycle is 21-day period and end of treatment visit occurs within 7 days after the determination of study discontinuation)
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 for CLCL161A1102 can be found on the Novartis Clinical Trial Results WebsiteLink provided by the sponsor.
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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 LCL161 and Paclitaxel in people with Neoplasms, 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 3 inclusion and 5 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?
Frequency of dose limiting toxicities as a function of LCL161 during first cycle (time frame: First cycle (21 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?
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.