Status:
COMPLETED
Phase I Study of PI3(Phosphoinositol 3)-Kinase Inhibitor BAY80-6946 With Paclitaxel in Patients With Advanced Cancer
Lead Sponsor:
Bayer
Conditions:
Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This open label Phase 1 study involves treating subjects with advanced cancer with BAY80-6946 in combination with paclitaxel. It will determine the maximum tolerated dose (MTD) and the recommended Pha...
Eligibility Criteria
Inclusion
- Subjects must have defined tumor classification (ie, TNBC, HER2+ or Luminal) for enrollment. If tumor classification is not available the subject cannot be enrolled. Tumor classification can be based on analysis of archived tumor tissue, or analysis of tumor tissue collected at any time proximal to screening. Subject profile can also be derived from analysis of fresh tumor tissue obtained during screening. Shipment of specimens (archival or fresh tumor tissue, blood, and plasma) to a central lab can take place after subject enrollment.
- No prior paclitaxel treatment for subjects in the dose escalation phase. MTD cohort expansion subjects may have had prior paclitaxel, but must not have experienced moderate or severe hypersensitivity reactions to the drug. Peripheral neuropathy must be Grade ≤ 1.
- Histological or cytological documentation of non-hematologic malignant solid tumor, excluding primary brain or spinal tumors. Patients with prior central nervous system metastases are eligible if all of the following apply: -- Definitive treatment for all lesions (eg, surgery, radiation) was completed at least three months prior to enrollment -- All lesions must be stable or improving on MRI scan performed within one month of enrollment -- All symptoms of the prior CNS metastases are stable.
- At least one measurable lesion or evaluable disease, as per RECIST 1.1
- ECOG Performance Status Assessment of 0 or 1
- Life expectancy of at least 12 weeks
Exclusion
- History of moderate to severe hypersensitivity (allergy) to drugs formulated in Cremophor® EL (polyoxyethylated castor oil), such as vitamin K, cyclosporin for injection concentrate and teniposide for injection concentrate
- Pre-existing interstitial lung disease and/or severe impaired pulmonary function
- History of cardiac disease; congestive heart failure (CHF) \>NYHA Class II; active coronary artery disease, myocardial infarction within 6 months prior to study entry; new onset angina within 3 months prior to study entry or unstable angina, or ventricular cardiac arrhythmias requiring anti-arrhythmic therapy
- Prior diagnosis of Type 1 or 2 diabetes mellitus, hyperglycemia (defined as consistent fasting blood or plasma glucose \> 125 mg/dL) or HgBA1c ≥ 7%
- Active clinically serious infections Grade ≥ 2 (NCI-CTCAE version 4.0), including viral hepatitis
- Poorly controlled seizure disorder
- Poorly controlled hypertension, defined as systolic blood pressure \> 150 mmHg or diastolic pressure \> 90 mmHg, despite optimal medical management
- Known human immunodeficiency virus (HIV) infection or chronic hepatitis C or B
- Subjects undergoing renal dialysis
- Known bleeding diathesis
- Pregnant or breast feeding women.
Key Trial Info
Start Date :
August 24 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 29 2015
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT01411410
Start Date
August 24 2011
End Date
June 29 2015
Last Update
October 11 2017
Active Locations (3)
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1
St Louis, Missouri, United States, 63110
2
New York, New York, United States, 10065
3
Houston, Texas, United States, 77030