Trial record 1 of 1 for:
((BAY86-9766 AND GIST) OR NCT01392521)
Phase Ib Study of PI3(Phosphoinositol 3)-Kinase Inhibitor BAY80-6946 With MEK (Mitogen-activated Protein Kinase) Inhibitor BAY86-9766 in Patients With Advanced Cancer
This study is currently recruiting participants.
Verified May 2013 by Bayer
Sponsor:
Bayer
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01392521
First received: June 30, 2011
Last updated: May 6, 2013
Last verified: May 2013
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Purpose
The PI3K (phosphoinositol 3-Kinase) inhibitor BAY80-6946 and the MEK (mitogen-activated protein kinase) inhibitor BAY86-9766 have both been tested as single agent treatments in other phase I studies. This study will test the combination of these two drugs to try and answer the following questions:
- What are the side effects of the combination of BAY80-6946 and BAY86-9766 when given together at different/increasing dose levels?
- What dose level of BAY80-6946 and BAY86-9766 should be tested in future clinical research studies?
- How much BAY80-6946 is in the blood at specific times after administration and does adding BAY86-9766 have an affect?
- How much BAY86-9766 is in the blood at specific times after administration and does adding BAY80-6946 have an affect?
- Does the combination of BAY86-9766 and BAY80-6946 have an effect on tumors?
| Condition | Intervention | Phase |
|---|---|---|
|
Neoplasms |
Drug: BAY80-6946 + BAY86-9766 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase Ib Trial of the Combination of PI3K Inhibitor BAY80-6946 and Allosteric-MEK Inhibitor BAY86-9766 in Subjects With Advanced Cancer |
Resource links provided by NLM:
Further study details as provided by Bayer:
Primary Outcome Measures:
- Maximum Tolerated Dose [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- Comparison of the BAY80-6946 AUC when given alone with the AUC when given with BAY86-9766 [ Time Frame: At day 15 ] [ Designated as safety issue: No ]
- Comparison of the BAY86-9766 AUC when given alone with the AUC when given with BAY80-6946 [ Time Frame: At day 15 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Tumor Response as measured by RECIST 1.1 criteria [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Biomarker evaluation including analysis of pathway activation in blood and plasma [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Tumor Response as measured by FDG-PET at MTD and expansion cohort(s) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Pharmacodynamic biomarker evaluation analysis using paired tumor biopsies [ Time Frame: 3 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 92 |
| Study Start Date: | July 2011 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Arm 1 |
Drug: BAY80-6946 + BAY86-9766
BAY80-6946 will be administered as an IV infusion weekly for 3 weeks in combination with BAY86-9766 at varying dose levels. BAY86-9766 is administered orally twice a day starting at Day 4 of Cycle 1.
Drug: BAY80-6946 + BAY86-9766
BAY80-6946 will be administered as an IV infusion weekly in combination with BAY86-9766 at varying dose levels. BAY86-9766 is administered orally twice a day starting at Day 6 of Cycle 1 on a 4 day on, 3 day off schedule.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01392521
Contacts
| Contact: Bayer Clinical Trials Contact | clinical-trials-contact@bayerhealthcare.com | |
| Contact: For trial location information (Phone Menu Options '3' or '4') | (+)1-888-84 22937 |
Locations
| United States, Arizona | |
| Recruiting | |
| Scottsdale, Arizona, United States, 85260 | |
| United States, Texas | |
| Recruiting | |
| Houston, Texas, United States, 77030 | |
| Germany | |
| Recruiting | |
| Freiburg, Baden-Württemberg, Germany, 79106 | |
| Netherlands | |
| Recruiting | |
| Rotterdam, Netherlands, 3015 CE | |
Sponsors and Collaborators
Bayer
Investigators
| Study Director: | Bayer Study Director | Bayer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Head of Clinical Sciences, Bayer Healthcare Pharmaceuticals Inc. |
| ClinicalTrials.gov Identifier: | NCT01392521 History of Changes |
| Other Study ID Numbers: | 12876, 2010-024082-45 |
| Study First Received: | June 30, 2011 |
| Last Updated: | May 6, 2013 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) United States: Food and Drug Administration |
Keywords provided by Bayer:
|
Safety Tolerability Pharmacokinetics |
Additional relevant MeSH terms:
|
Neoplasms |
ClinicalTrials.gov processed this record on May 23, 2013