A Study of LCL161 in Combination With Weekly Paclitaxel in Adult Patients With Advanced Solid Tumors

Solid Tumors Clinical Trial

Official title:

A Phase Ib Study of LCL161 in Combination With Weekly Paclitaxel in Adult Patients With Advanced Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01240655
• Other study ID #: CLCL161A2104
• Secondary ID: 2009-015594-12
• Status: Completed
• Phase: Phase 1
• Start date: April 2011
• Est. completion date: January 2015

Study information

• Verified date: September 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

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 Exclusion Criteria: 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 = 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 = 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 ß-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

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumors

Intervention

Drug:
• LCL161

• Paclitaxel

Locations

Country	Name	City	State
Canada	Novartis Investigative Site	Vancouver	British Columbia
Italy	Novartis Investigative Site	Modena	MO
Spain	Novartis Investigative Site	Barcelona	Catalunya
Spain	Novartis Investigative Site	Barcelona	Catalunya
United States	Dana Farber Cancer Institute SC	Boston	Massachusetts
United States	University of North Carolina Lineberger Comp Cancer Ctr	Chapel Hill	North Carolina
United States	Sarah Cannon Research Institute DeptofSarahCannonRes.Inst. (2)	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Canada,  Italy,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated dose (MTD)/RP2D of LCL161 when administered in combination with once weekly paclitaxel		24 months
Secondary	Safety and tolerability of the combination, including acute and chronic toxicities		24 months
Secondary	Pharmacokinetics of both LCL161 and paclitaxel when administered in combination (AUC0-8, Cmax, tmax and other parameters as appropriate)		24 months
Secondary	Preliminary anti-tumor activity associated with this combination treatment		24 months
Secondary	Target inhibition, cell death, and cytokines in surrogate and tumor tissues		24 months

External Links

•   Results for CLCL161A2104can be found on the Novartis Clinical Trial Results Website