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Phase Ib Trial of the Combination of PI3K Inhibitor BAY80-6946 and Allosteric-MEK Inhibitor BAY86-9766 in Subjects With Advanced Cancer


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Neoplasms

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Trial Information

Phase Ib Trial of the Combination of PI3K Inhibitor BAY80-6946 and Allosteric-MEK Inhibitor BAY86-9766 in Subjects With Advanced Cancer


Inclusion Criteria:



- Age greater than/equal to 18 years old

- ECOG Performance Status of 0 - 1

- Life expectancy of at least 12 weeks

- Patients with advanced, histologically or cytologically confirmed solid tumors,
refractory to any standard therapy or have no standard therapy available

- LVEF (left ventricular ejection fraction) > or = to the lower limit of normal for the
institution

- Radiographically or clinically evaluable tumor

- Adequate bone marrow, liver and renal function as assessed by the following
laboratory requirements to be conducted within 14 days prior to start of first dose:

- Hemoglobin > 9.0 g/dL

- Absolute neutrophil count (ANC) > or = 1500/mm3

- Platelet count > or = 100,000 /mm3

- Total bilirubin < or = 1.5 times the upper limit of normal

- ALT (alanine aminotransferase) and AST (aspartate aminotransferase) < or = 2.5 x
upper limit of normal (< or = 5 x upper limit of normal for patients with liver
involvement)

- PT-INR (prothrombin-international normalized ratio) and PTT (partial
thromboplastin time) < or = 1.5 times the upper limit of normal

- Serum creatinine < or = 1.5 times the upper limit of normal

Exclusion Criteria:

- History of impaired cardiac function or clinically significant cardiac disease (i.e.
congestive heart failure (CHF) NYHA (New York Heart Association) Class III or IV);
active coronary artery disease, myocardial infarction within 6 months of study entry;
new onset or unstable angina within 3 months of study entry, or cardiac arrhythmias
requiring anti-arrhythmic therapy

- Type 1 or type 2 diabetes mellitus or fasting glucose > 125 mg/dL or HgBA1c > or =
7.0

- Use of systemic corticosteroids within 2 weeks of study entry

- History of retinal vein occlusion

- Known glucose-6-phosphate dehydrogenase (G6PD) deficiency

- Active clinically serious infection

- Uncontrolled hypertension

- Positive for HIV, or chronic Hepatitis B or C

- Subjects undergoing renal dialysis

- Known bleeding diathesis

- Ongoing substance abuse

- Pregnant or breast-feeding women

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum Tolerated Dose

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

Bayer Study Director

Investigator Role:

Study Director

Investigator Affiliation:

Bayer

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

12876

NCT ID:

NCT01392521

Start Date:

July 2011

Completion Date:

September 2013

Related Keywords:

  • Neoplasms
  • Safety
  • Tolerability
  • Pharmacokinetics
  • Neoplasms

Name

Location

Phoenix, Arizona  85012
Austin, Texas  78705