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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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11 January 2021 |
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Main ID: |
NCT01068483 |
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Date of registration:
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11/02/2010 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Safety of BKM120 Monotherapy in Advanced Solid Tumor Patients
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Scientific title:
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A Phase IA, Multicenter, Open-label Dose Escalation Study of BKM120, Administered Orally in Adult Patients With Advanced Solid Malignancies |
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Date of first enrolment:
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November 2008 |
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Target sample size:
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107 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01068483 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1
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Countries of recruitment
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Canada
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Netherlands
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Spain
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United States
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Contacts
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Name:
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Novartis Pharmaceuticals |
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Address:
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Telephone:
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Email:
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Affiliation:
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Novartis Pharmaceuticals |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
All patients:
- Histologically-confirmed advanced solid tumors
- Progressive, recurrent unresectable disease
- World Health Organization (WHO) Performance status = 2
- No history of primary brain tumor or brain metastases
MTD Expansion part:
- Histologically-confirmed advanced solid tumors
- Progressive, recurrent unresectable disease
- World Health Organization (WHO) Performance status = 2
- No history of primary brain tumor; no brain metastases unless asymptomatic and
clinically stable for = 3 months
- Patients with genetic or molecular alteration of the PI3K pathway
Exclusion Criteria:
- Prior treatment with a PI3K inhibitor
- History of or active major depressive episode, bipolar disorder, schizophrenia, or
history of suicidal attempt or ideation
- No clinically manifest diabetes mellitus (treated and/or with clinical signs)
- No acute or chronic renal disease
- No acute or chronic liver disease
- No acute or chronic pancreatitis
- No unresolved diarrhea
- No impaired cardiac function or clinically significant cardiac diseases such as
ventricular arrhythmia, congestive heart failure, uncontrolled hypertension
- No acute myocardial infarction or unstable angina pectoris within the past 3 months
- Not pregnant or nursing and fertile patients must use barrier contraceptives
Other protocol-defined inclusion/exclusion criteria may apply
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Ovarian Cancer
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Breast Cancer
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Colon Cancer
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Endometrium Cancer
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Intervention(s)
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Drug: BKM120
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Primary Outcome(s)
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Maximum Tolerated Dose (MTD) of BKM120
[Time Frame: throughout the study]
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Secondary Outcome(s)
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Changes in tumor metabolic activity
[Time Frame: throughout the study]
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Pharmacodynamics of BKM120
[Time Frame: throughout the study]
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Safety and tolerability of BKM120
[Time Frame: throughout the study]
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Clinical tumor response in patients with tumors that show PI3K pathway activation
[Time Frame: throughout the study]
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Pharmacokinetics of BKM120
[Time Frame: throughout the study]
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Secondary ID(s)
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CBKM120X2101
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2008-002652-17
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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