Status:
COMPLETED
Phase I Dose Escalation Study With an Allosteric AKT 1/2 Inhibitor in Patients
Lead Sponsor:
Bayer
Conditions:
Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is the first study where BAY1125976 is given to humans. Patients (all comers) will receive the study drug treatment in a dose-escalation scheme (no placebo group) to determine the safety, tolerab...
Eligibility Criteria
Inclusion
- For dose escalation cohorts: Subjects with advanced, histologically or cytologically confirmed solid tumors are eligible. Subjects' tumors (all comers) must be refractory to standard treatment with no standard therapy available, or subjects actively refuse any treatment, which would be regarded standard. In addition, the investigator must judge the experimental treatment as clinically and ethically acceptable
- For expansion cohort only: Subjects with histologically or cytologically proven metastatic breast cancer (with and without AKT1 E17K (G49A) mutation) or subjects with known AKT1 E17K (G49A) mutation in any other advanced solid tumor with at least one line of chemotherapy in the metastatic setting and not amenable to surgery with curative intent
- Subjects must have measurable disease (Response evaluation criteria in solid tumors (RECIST 1.1)
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 - 2
- Bone marrow, liver and renal functions as assessed by adequate laboratory methods to be conducted within 7 days prior to starting study treatment
- Subjects must provide tumor biopsies before treatment
- Recovery to CTCAE (Common Terminology Criteria for Adverse Events Version 4.03) Grade 0 or Grade 1 or recovery to baseline preceding the prior treatment of any previous drug / procedure-related toxicity (except alopecia, anemia, and hypothyroidism)
Exclusion
- History of cardiac disease including congestive heart failure \> New York Heart Association (NYHA) Class II
- Subjects with type 1 or type 2 diabetes mellitus
- Subjects with fasting glucose \>125 mg/dL in 2 independent measurements or glycated hemoglobin (HbA1c) ≥ 7%
- Moderate and severe hepatic impairment, i.e. Child-Pugh B or C
- Active infections of CTCAE (Common Terminology Criteria for Adverse Events Version 4.03) Grade \>2 or infections of CTCAE Grade 2 not responding to therapy
- Symptomatic metastatic brain or meningeal tumors unless the patient is \> 3 months from definitive therapy, has a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry.
- Subjects undergoing renal dialysis
- Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis \& T1) or any cancer curatively treated \> 3 years prior to study entry
- Autologous bone marrow transplant or stem cell rescue within 4 months of study entry
- Treatment with oral steroids (dose ≥ 10 mg/day of methylprednisolone or equivalent)
- Clinically relevant findings in the ECG such as a second- or third-degree AV block, prolongation of the QRS complex over 120 msec or of the QTcF-interval over 450 msec
- Acute toxic effects of previous anticancer chemotherapy or immunotherapy have to be normalized to CTCAE Grade equal or lower than 1 (excluding alopecia)
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT01915576
Start Date
September 1 2013
End Date
December 1 2016
Last Update
December 28 2016
Active Locations (7)
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1
Santa Monica, California, United States, 90404
2
Boston, Massachusetts, United States, 02215
3
St Louis, Missouri, United States, 63110
4
Houston, Texas, United States, 77030