Status:
TERMINATED
BKM120 in Esophageal Squamous Cell Carcinoma After Failure of First Line Chemotherapy
Lead Sponsor:
Prince of Songkla University
Conditions:
Esophageal Cancer
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
There is a need for more effective therapy for patients with esophageal squamous cell carcinoma who developed disease progression after first line therapy. Currently, there is no standard second-line ...
Eligibility Criteria
Inclusion
- Patient has provided a signed Informed Consent Form (ICF) obtained prior to any screening procedure.
- Age ≥ 18 years old
- Histologically confirmed diagnosis of esophageal squamous cell carcinoma and available archival tissue for evaluation of further studies.
- Metastatic or unresectable disease
- Received one prior chemotherapy or biological therapy regimen for unresectable or metastatic disease
- More than 30 days since prior chemotherapy, surgery, radiotherapy, or investigational agents
- Measurable disease in at least 1 diameter by CT scan or MRI as per RECIST 1.1 criteria
- No evidence of brain metastasis
- ECOG ≤ 2
- Patient has adequate bone marrow and organ function
- Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L
- Platelets ≥ 100 x 109/L
- Hemoglobin ≥ 9.0 g/dL
- INR ≤ 2
- Potassium, calcium, magnesium within normal limits for the institution
- Serum Creatinine ≤ 1.5 x ULN or Creatinine clearance \> 60 mL
- AST and ALT not more than 2.5 times ULN (not more than 5.0 times ULN if there is liver metastasis)
- Serum bilirubin within normal range (or ≤ 1.5 x ULN if liver metastases are present; or total bilirubin ≤ 3.0 x ULN with direct bilirubin within normal range in patients with well documented Gilbert Syndrome)
- Fasting serum glucose \< 1.5 times ULN
Exclusion
- Patient has received previous treatment with PI3K inhibitors
- Patient has symptomatic CNS metastases
- Patients with controlled and asymptomatic CNS metastases may participate in this trial. As such, the patient must have completed any prior treatment for CNS metastases \> 28 days (including radiotherapy and/or surgery) prior to enrollment in this study and should not be receiving chronic corticosteroid therapy for the CNS metastases.
- Patient has a concurrent malignancy or has a malignancy within 5 years of study enrollment, (with the exception of nonmelanoma skin cancer or cervical carcinoma in situ.
- Patient has any of the following mood disorders as judged by the Investigator or a Psychiatrist, or meets the cut-off score of ≥ 10 in the PHQ-9 or a cut-off of ≥ 15 in the GAD-7 mood scale, respectively, or selects a positive response of '1, 2, or 3' to question number 9 regarding potential for suicidal thoughts ideation in the PHQ-9 (independent of the total score of the PHQ-9)
- Medically documented history of or active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, or homicidal ideation (immediate risk of doing harm to others) ≥ CTCAE grade 3 anxiety
- Patient is concurrently using other approved or investigational antineoplastic agent
- Patient has had major surgery within 28 days prior to starting study drug or has not recovered from major side effects of the surgery
- Patient has poorly controlled diabetes mellitus(HbA1c \> 8 %)
- Patient has active cardiac disease including any of the following:
- LVEF \< 50%
- QTc \> 480 msec on screening ECG (using the QTcF formula)
- Angina pectoris that requires the use of anti-anginal medication
- Ventricular arrhythmias except for benign premature ventricular contractions
- Supraventricular and nodal arrythmias requiring a pacemaker or not controlled with medication
- Conduction abnormality requiring a pacemaker
- Valvular disease with documented compromise in cardiac function
- Symptomatic pericarditis
- Patient has a history of cardiac dysfunction including any of the following;
- Myocardial infarction within the last 6 months, documented by persistent elevated cardiac enzymes or persistent regional wall abnormalities on assessment of LVEF function
- History of documented congestive heart failure (New York Heart Association functional classification III-IV)
- Documented cardiomyopathy
- Patient is currently receiving treatment with QT prolonging medication known to have a risk to induce Torsades de Pointes, and the treatment cannot be discontinued or switched to a different medication prior to starting study drug
- Inability to swallow, impaired gastrointestinal (GI) function, or GI disease that would significantly alter the absorption of study drugs or preclude the use of oral medications
- Patient has other concurrent severe and/or uncontrolled medical condition that would, in the investigator's judgment contraindicate her participation in the clinical study (e.g.,chronic pancreatitis, active chronic hepatitis etc.)
- Patient is currently being treated with drugs known to be moderate and strong inhibitors or inducers of isoenzyme CYP3A, and the treatment cannot be discontinued or switched to a different medication prior to starting study drug.
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2016
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT01806649
Start Date
July 1 2013
End Date
April 30 2016
Last Update
October 11 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Songklanagarind Hospital, Prince of Songkla University
Hat Yai, Changwat Songkhla, Thailand, 90110