Status:
COMPLETED
A Study of LCL161 in Combination With Weekly Paclitaxel in Adult Patients With Advanced Solid Tumors
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Solid Tumors
Eligibility:
All Genders
18-100 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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 β-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
Key Trial Info
Start Date :
April 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT01240655
Start Date
April 1 2011
End Date
January 1 2015
Last Update
December 19 2020
Active Locations (7)
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1
Dana Farber Cancer Institute SC
Boston, Massachusetts, United States, 02215
2
University of North Carolina Lineberger Comp Cancer Ctr
Chapel Hill, North Carolina, United States, 27514
3
Sarah Cannon Research Institute DeptofSarahCannonRes.Inst. (2)
Nashville, Tennessee, United States, 37203
4
Novartis Investigative Site
Vancouver, British Columbia, Canada, V5Z 1L3