Advanced Solid TumorsPhase 1NCT01098838
Safety and Efficacy of LCL161 in Patients With Solid Tumors
A Phase 1 study testing LCL161 in people with Advanced Solid Tumors, run by Novartis Pharmaceuticals at 3 sites in United States.
Trial summary
The study will evaluate the safety of increasing doses of oral LCL161 in patients with solid tumors. It is primarily designed to evaluate the side effects and find the maximum tolerated dose of LCL161. 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?
- LCL161
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 3 sitesUnited States
- Study dates
- Nov 2008to Jan 2011
- 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
- Solid tumor
- ECOG performance status 0-2
- Life expectancy greater than or equal to 12 weeks
- Must meet certain blood laboratory values
- Must meet criteria for time since the last dose of prior therapy
- Must provide written informed consent to participate in this study
Who cannot join
- Active and/or symptomatic brain tumors or brain metastases.
- Patients with unresolved nausea, vomiting, or diarrhea
- Any ongoing severe and/or uncontrolled medical condition that could compromise participation in the study including heart, lung or inflammatory disease
- Any disease that may significantly alter the absorption of the study drug (for example, ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or removal of small bowel)
- Patients who are currently receiving treatment with steroids at a certain dose or other immunosuppressive treatment that cannot be stopped prior to starting study drug
- Patients who are currently receiving treatment with certain medications
Show all 11Show fewer
- Patients who have received radiation therapy or have undergone major surgery within the last 4 weeks
- Women of child-bearing potential who are pregnant or breast feeding.
- Known diagnosis of human immunodeficiency virus (HIV) infection or chronic active hepatitis B or C
- Patients unwilling or unable to follow the protocol
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
3 sites in 1 country.
United States3 sites
UNC/ Lineberger Comprehensive Cancer Center Dept. of LinbergerCancerCtr(2)
Chapel Hill, North Carolina, 27599-7295
Sarah Cannon Research Institute DeptofSarahCannonRes.Inst. (2)
Nashville, Tennessee, 37203
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111-2497
About this study
Official title: A Phase I, Multi-center, Open-label, Dose-escalation Study of Oral LCL161 in Adult Patients With Advanced Solid Tumors
The study will evaluate the safety of increasing doses of oral LCL161 in patients with solid tumors. It is primarily designed to evaluate the side effects and find the maximum tolerated dose of LCL161.
- Conditions
- Advanced Solid Tumors
- Being tested
- LCL161
- Keywords
- Cancer, adults, solid tumor, apoptosis, programmed cell death, LCL161
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LCL161Drug
| Study group | Role | What they receive |
|---|---|---|
| Weekly dosing of LCL161 | Experimental | by mouth (oral) Receives: Drug: LCL161 |
| Comparison of LCL161 | Experimental | tablet versus liquid Receives: Drug: LCL161 |
| Twice daily dosing of LCL161 | Experimental | by mouth for 4 days followed by a 3-day rest period every week Receives: Drug: LCL161 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of dose-limiting toxicities
Measured: Cycle 1
Secondary outcomes (5)
Frequency and type of adverse events
Measured: throughout the study
Comparison of amount of LCL161 that gets into blood stream from tablet formulation versus liquid formulation (bioavailability)
Measured: 3 months
Blood assessments to determine how much LCL161 gets into the blood stream (pharmacokinetic parameters)
Measured: 4 weeks
Pharmacodynamic measurements to determine how LCL161 interacts with proteins related to cancer such as cIAP, cytokines, and cell death markers; hair, skin and tumor samples will be evaluated for target inhibition
Measured: Intermittent throughout treatment period
Solid tumor response criteria will be used to identify any anti-tumor activity
Measured: After a minimum of 2 cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2010 (estimated)
- Study startNov 2008
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- 71 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
- NCT01098838
- Sponsor's protocol ID
- CLCL161A2101
- Status last verified
- Aug 2012
- First submitted
- 1 Apr 2010
- Last updated
- 3 Aug 2012
- Results posted
- No
Publications
Infante JR, Dees EC, Olszanski AJ, Dhuria SV, Sen S, Cameron S, Cohen RB. Phase I dose-escalation study of LCL161, an oral inhibitor of apoptosis proteins inhibitor, in patients with advanced solid tumors. J Clin Oncol. 2014 Oct 1;32(28):3103-10. doi: 10.1200/JCO.2013.52.3993. Epub 2014 Aug 11.
PubMed 25113756
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2012. 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 Oral LCL161 in Adult Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT01098838
- Acronym / sponsor ID
- CLCL161A2101
- Conditions
- Advanced Solid Tumors
- Keywords
- Cancer, adults, solid tumor, apoptosis, programmed cell death, LCL161
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 5 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.
The study will evaluate the safety of increasing doses of oral LCL161 in patients with solid tumors. It is primarily designed to evaluate the side effects and find the maximum tolerated dose of LCL161.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Weekly dosing of LCL161 | Experimental | Drug: LCL161by mouth (oral) |
| Comparison of LCL161 | Experimental | Drug: LCL161tablet versus liquid |
| Twice daily dosing of LCL161 | Experimental | Drug: LCL161by mouth for 4 days followed by a 3-day rest period every week |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Solid tumor
- ECOG performance status 0-2
- Life expectancy greater than or equal to 12 weeks
- Must meet certain blood laboratory values
- Must meet criteria for time since the last dose of prior therapy
Key exclusion criteria (11 listed)
- Active and/or symptomatic brain tumors or brain metastases.
- Patients with unresolved nausea, vomiting, or diarrhea
- Any ongoing severe and/or uncontrolled medical condition that could compromise participation in the study including heart, lung or inflammatory disease
- Any disease that may significantly alter the absorption of the study drug (for example, ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or removal of small bowel)
- Patients who are currently receiving treatment with steroids at a certain dose or other immunosuppressive treatment that cannot be stopped prior to starting study drug
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 |
|---|---|---|
| LCL161 | Drug | Comparison of LCL161, Twice daily dosing of LCL161, Weekly dosing of LCL161 |
Primary outcome
Occurrence of dose-limiting toxicities
Time frame: Cycle 1
5 secondary outcomes
Frequency and type of adverse events
Time frame: throughout the study
Comparison of amount of LCL161 that gets into blood stream from tablet formulation versus liquid formulation (bioavailability)
Time frame: 3 months
Blood assessments to determine how much LCL161 gets into the blood stream (pharmacokinetic parameters)
Time frame: 4 weeks
Pharmacodynamic measurements to determine how LCL161 interacts with proteins related to cancer such as cIAP, cytokines, and cell death markers; hair, skin and tumor samples will be evaluated for target inhibition
Time frame: Intermittent throughout treatment period
Solid tumor response criteria will be used to identify any anti-tumor activity
Time frame: After a minimum of 2 cycles
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 3 Aug 2012.
- Derived from this study: PubMed 25113756Infante JR, Dees EC, Olszanski AJ, Dhuria SV, Sen S, Cameron S, Cohen RB. Phase I dose-escalation study of LCL161, an oral inhibitor of apoptosis proteins inhibitor, in patients with advanced solid tumors. J Clin Oncol. 2014 Oct 1;32(28):3103-10. doi: 10.1200/JCO.2013.52.3993. Epub 2014 Aug 11.
- Related InfoLink 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
3 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 in people with Advanced Solid Tumors, run by Novartis Pharmaceuticals at 3 sites in United States.
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 6 inclusion and 11 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 3 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
Occurrence of dose-limiting toxicities (time frame: Cycle 1). 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 NCT01098838, which also lists 1 linked publication.
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 3 Aug 2012.