A Phase 1 interventional study of LCL161 and Paclitaxel in Neoplasms, sponsored by Novartis Pharmaceuticals. Completed at 2 sites in Japan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-12-19.
Sponsored by Novartis Pharmaceuticals · Phase 1, Interventional, and Treatment
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.
9,359 studies on the registry are indexed under Neoplasms; 2,486 are open to participants now.
This study's enrollment of 9 is below the median of 50 across 7,250 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
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.
Drug: LCL161 · Drug: Paclitaxel
Patients will receive oral LCL161 once a week until unacceptable toxicity, disease progression and/or withdrawal of consent.
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.
Frequency of dose limiting toxicities as a function of LCL161 during first cycle
Time frame: 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
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)
Adverse events of oral LCL161
Type and frequency of 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)
This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Novartis Pharmaceuticals