NCT Number: NCT01098838
Safety and Efficacy of LCL161 in Patients With 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.
Looking for future studies?
Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1
Primary location
UNC/ Lineberger Comprehensive Cancer Center Dept. of LinbergerCancerCtr(2), Chapel Hill, North Carolina, United States
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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
Exclusion criteria
- 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
- 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
Treatment and study plan
Primary outcomes
-
Occurrence of dose-limiting toxicities
Time frame: Cycle 1
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
Sponsors and collaborators
Lead sponsor
Novartis Pharmaceuticals
Industry
Registry information
Official study title
A Phase I, Multi-center, Open-label, Dose-escalation Study of Oral LCL161 in Adult Patients With Advanced Solid Tumors
Important dates
- Study start
- 2008
- Primary completion
- 2011
- Study completion
- 2011
- First posted
- Apr 5, 2010
- Registry last updated
- Aug 3, 2012
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Phase 1/2 Study of X-396, an Oral ALK Inhibitor, in Patients With ALK-positive Non-Small Cell Lung Cancer
NCT01625234
Advanced Solid Tumors, Bronchial Neoplasms
Duarte, California, United States
View Trial DetailsA Study With ABBV-155 Alone and in Combination With Taxane Therapy in Adults With Relapsed and/or Refractory Solid Tumors
NCT03595059
Advanced Solid Tumors, Breast Diseases
Birmingham, Alabama, United States
View Trial DetailsA Study to Evaluate the Safety and Tolerability of BMS-986408 Alone and in Combination With Nivolumab or Nivolumab and Ipilimumab in Participants With Advanced Solid Tumors
NCT05407675
Advanced Solid Tumors, Neoplasms
Boston, Massachusetts, United States
View Trial DetailsPharmacokinetic Study of Lurbinectedin in Combination With Irinotecan in Patients With Selected Solid Tumors
NCT02611024
Adenoma, Adnexal Diseases
Santa Monica, California, United States
View Trial Details