A Study of LCL161 in Combination With Weekly Paclitaxel in Adult Patients With Advanced Solid Tumors
- Registration Number
- NCT01240655
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
This is a dose escalation study that will assess the safety and efficacy of LCL161 in combination with weekly paclitaxel in adult patients with advanced solid tumors.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 76
Patients with breast cancer must have a histologically or cytologically confirmed diagnosis of disease that has metastasized or is resistant to therapy.
Patients with ovarian cancer must have histological evidence of recurrent epithelial ovarian, fallopian tube or peritoneal cancer.
Patients must have recovered or stabilized from all toxicities related to their previous treatment except for alopecia Male or female patients 18 years or older ECOG performance status 0-1 Life expectancy greater than 12 weeks Measurable disease as determined by RECIST v1.0 Patients must give written informed consent and comply with the protocol
For patients with breast cancer:
Concurrent Her2-directed or anti-estrogen therapy
For patients with ovarian cancer:
Primary refractory disease, defined as progression during initial treatment with a platinum- and taxane-containing regimen.
Prior treatment with weekly paclitaxel. More than two chemotherapy regimens given in the relapse setting. Evidence of a documented bowel obstruction within six months of study entry Patients with unresolved peripheral neuropathy, nausea, vomiting, or diarrhea β₯ CTCAE Grade 2 Any concurrent severe and/or uncontrolled medical conditions that could increase the patient's risk for toxicity while in the study or that could confound discrimination between disease- and study treatment-related toxicities.
Patients with impairment of GI function or GI disease that may significantly alter the absorption of LCL161 Patients who have undergone major surgery β€ 3 weeks prior to starting study drug or who have not recovered from side effects of procedure.
Pregnant or breast feeding (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive Ξ²-HCG laboratory test (> 5 mIU/mL).
Known diagnosis of human immunodeficiency virus (HIV) infection or chronic active hepatitis B or C (HIV and hepatitis testing are not mandatory).
Other protocol-defined inclusion/exclusion criteria may apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description LCL161 + Paclitaxel LCL161 - LCL161 + Paclitaxel Paclitaxel -
- Primary Outcome Measures
Name Time Method Maximum tolerated dose (MTD)/RP2D of LCL161 when administered in combination with once weekly paclitaxel 24 months
- Secondary Outcome Measures
Name Time Method Safety and tolerability of the combination, including acute and chronic toxicities 24 months Target inhibition, cell death, and cytokines in surrogate and tumor tissues 24 months Pharmacokinetics of both LCL161 and paclitaxel when administered in combination (AUC0-β, Cmax, tmax and other parameters as appropriate) 24 months Preliminary anti-tumor activity associated with this combination treatment 24 months
Trial Locations
- Locations (4)
Dana Farber Cancer Institute SC
πΊπΈBoston, Massachusetts, United States
University of North Carolina Lineberger Comp Cancer Ctr
πΊπΈChapel Hill, North Carolina, United States
Novartis Investigative Site
πͺπΈBarcelona, Catalunya, Spain
Sarah Cannon Research Institute DeptofSarahCannonRes.Inst. (2)
πΊπΈNashville, Tennessee, United States