Advanced Solid TumorsPhase 1NCT01106508
A Dose Finding and Safety Study of Oral LEQ506 in Patients With Advanced Solid Tumors
A Phase 1 study testing LEQ506 in people with Advanced Solid Tumors and Recurrent or Refractory Medulloblastoma, run by Novartis Pharmaceuticals at 5 sites in 4 countries.
Trial summary
This first-in-human dose-escalation study is to characterize the safety, tolerability, pharmacokinetics and pharmacodynamics of LEQ506 given orally on a daily dosing schedule in patients with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors, Recurrent or Refractory Medulloblastoma, Locally Advanced or Metastatic Basal Cell Carcinoma
- What is being tested?
- LEQ506
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 5 sitesin 4 countries
- Study dates
- Oct 2010to 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
- Confirmed diagnosis of advanced solid tumor, recurrent or refractory medulloblastoma or locally advanced or metastatic basal cell carcinoma)
- Protocol defined laboratory parameters
- Performance status ≤ 2
- Patients must have fully recovered from the prior effects of major surgery and from any acute toxicities of prior chemotherapy/radiotherapy
Who cannot join
- History of central nervous system tumors of symptomatic brain metastases (excludes medulloblastoma patients)
- Impairment of gastrointestinal function or unresolved nausea, vomiting or diarrhea
- Impairment of cardiac function or significant cardiac disease
- Pregnant or lactating women
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
5 sites in 4 countries.
5 sites in 4 countries
United States2 sites
University of California at Los Angeles UCLA LeConte Location
Los Angeles, California, 90095
Memorial Sloan Kettering Cancer Center
New York, New York, 10021
About this study
Official title: A Phase I, Multi-center, Open Label, Dose Escalation Study of LEQ506, an Oral Smoothened Inhibitor, in Patients With Advanced Solid Tumors
This first-in-human dose-escalation study is to characterize the safety, tolerability, pharmacokinetics and pharmacodynamics of LEQ506 given orally on a daily dosing schedule in patients with advanced solid tumors.
- Conditions
- Advanced Solid Tumors, Recurrent or Refractory Medulloblastoma, Locally Advanced or Metastatic Basal Cell Carcinoma
- Being tested
- LEQ506
- Keywords
- Advanced solid tumors, recurrent or refractory medulloblastoma, locally advanced or metastatic basal cell carcinoma, hedgehog pathway inhibitor
- Medical subject headings
- Recurrence, Medulloblastoma, Carcinoma, Basal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LEQ506Drug
| Study group | Role | What they receive |
|---|---|---|
| LEQ506 | Experimental | Not described Receives: Drug: LEQ506 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the maximum tolerated dose and characterize the dose limiting toxicities of LEQ506
Measured: 21 day cycles
Secondary outcomes (4)
To characterize the safety and tolerability of LEQ506 treatment
Measured: 21 day cycles
To characterize the pharmacokinetics of LEQ506
Measured: 21 day cycles
To characterize the pharmacodynamic effects of LEQ506 in skin and tumor samples
Measured: 21 day cycles
Tumor response
Measured: every 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2010 (estimated)
- Study startOct 2010
- 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 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 57 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
- NCT01106508
- Sponsor's protocol ID
- CLEQ506X2101
- Other IDs
- 2009-017969-30, 2009
- Status last verified
- Jan 2016
- First submitted
- 16 Apr 2010
- Last updated
- 17 Dec 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Multi-center, Open Label, Dose Escalation Study of LEQ506, an Oral Smoothened Inhibitor, in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT01106508
- Acronym / sponsor ID
- CLEQ506X2101
- Conditions
- Advanced Solid Tumors, Recurrent or Refractory Medulloblastoma, Locally Advanced or Metastatic Basal Cell Carcinoma
- Keywords
- Advanced solid tumors, recurrent or refractory medulloblastoma, locally advanced or metastatic basal cell carcinoma, hedgehog pathway inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 20 Apr 2010 (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 first-in-human dose-escalation study is to characterize the safety, tolerability, pharmacokinetics and pharmacodynamics of LEQ506 given orally on a daily dosing schedule in patients with advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LEQ506 | Experimental | Drug: LEQ506 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Confirmed diagnosis of advanced solid tumor, recurrent or refractory medulloblastoma or locally advanced or metastatic basal cell carcinoma)
- Protocol defined laboratory parameters
- Performance status ≤ 2
- Patients must have fully recovered from the prior effects of major surgery and from any acute toxicities of prior chemotherapy/radiotherapy
Key exclusion criteria (5 listed)
- History of central nervous system tumors of symptomatic brain metastases (excludes medulloblastoma patients)
- Impairment of gastrointestinal function or unresolved nausea, vomiting or diarrhea
- Impairment of cardiac function or significant cardiac disease
- Pregnant or lactating women
- 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 |
|---|---|---|
| LEQ506 | Drug | LEQ506 |
Primary outcome
To determine the maximum tolerated dose and characterize the dose limiting toxicities of LEQ506
Time frame: 21 day cycles
4 secondary outcomes
To characterize the safety and tolerability of LEQ506 treatment
Time frame: 21 day cycles
To characterize the pharmacokinetics of LEQ506
Time frame: 21 day cycles
To characterize the pharmacodynamic effects of LEQ506 in skin and tumor samples
Time frame: 21 day cycles
Tumor response
Time frame: every 6 weeks
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 17 Dec 2020.
- Results for CLEQ506X2101 on the Novartis Clinical Trials 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
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LEQ506 in people with Advanced Solid Tumors and Recurrent or Refractory Medulloblastoma, run by Novartis Pharmaceuticals at 5 sites in 4 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 4 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 17 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 5 sites in United States, Netherlands, Switzerland, United Kingdom. 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?
To determine the maximum tolerated dose and characterize the dose limiting toxicities of LEQ506 (time frame: 21 day cycles). 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 17 Dec 2020.