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

Status: Recruiting
Phase: Phase 1
Diagnosis: Breast: Metastatic, GYN: Ovarian, Fallopian, Peritoneal Cancer
NCT ID: NCT01240655 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 11-063


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.


Conducting Institutions:
Dana-Farber Cancer Institute

Overall PI:
Erica Mayer, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:

Dana-Farber Cancer Institute: Breast Cancer Nursing Team, 617-632-3478
Dana-Farber Cancer Institute: Christin Whalen, 617-582-7738, cwhalen@partners.org

Eligibility Criteria

Inclusion Criteria: 1. Patients with a histologically or cytologically confirmed diagnosis of a solid tumor that has progressed despite standard therapy, or for which no standard therapy exists 1. Patients with breast cancer must have a histologically or cytologically confirmed diagnosis of disease that has metastasized or is resistant to therapy 2. Patients with ovarian cancer must have histological evidence of recurrent epithelial ovarian, fallopian tube or peritoneal cancer and must have received a platinum- and taxane-based chemotherapy regimen for management of primary disease. 2. Male or female patients 18 years or older 3. ECOG performance status 0-1 4. Life expectancy ≥ 12 weeks 5. Patients must give written informed consent and comply with the protocol Exclusion Criteria: 1. Progressive disease on a taxane-containing regimen within the last 3 months a. This criterion does not apply to patients with ovarian cancer in the safety expansion group For patients with breast cancer, a. Concurrent Her2-directed or anti-estrogen therapy For patients with ovarian cancer: 1. Primary refractory disease, defined as progression during initial treatment with a platinum- and taxane-containing regimen. 2. Prior treatment with weekly paclitaxel. 3. More than two chemotherapy regimens given in the relapse setting. 4. Evidence of a documented bowel obstruction within six months of study entry 2. Patients with primary central nervous system tumors or brain metastases 3. Patients with unresolved peripheral neuropathy, nausea, vomiting, or diarrhea 4. Patients with a hypersensitivity to drugs formulated in Cremophor® EL (polyoxyethylated castor oil) 5. Patients with impairment of GI function or GI disease 6. Impaired cardiac function or clinically significant cardiac diseases 7. Patients with a clinically significant pulmonary disease or any requirement for supplemental O2 8. Patients who are currently receiving chronic treatment with corticosteroids or any other chronic immunosuppressive treatment that cannot be discontinued 9. 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
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