Safety of BKM120 Monotherapy in Advanced Solid Tumor Patients
Completed · Phase 1
Conditions studied: Breast Cancer, Colon Cancer, Ovarian Cancer, Endometrium Cancer
In brief
This is a first-in-man, phase I clinical research study with BKM120, a potent and highly specific oral pan-class I phosphatidylinositol-3-kinase (PI3K) inhibitor. The study consists of a dose escalation part followed by a MTD expansion part. Once the MTD has been defined, the MTD expansion part will be opened for enrollment.
Key facts
- Study ID
- NCT01068483
- Run by
- Novartis Pharmaceuticals
- People needed
- 107
- Starts
- 2008-11-01
- Expected to finish
- 2012-08-01
- Last updated by the study team
- 2020-12-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Sarah Cannon Research Institute Dept.ofSarahCannonCancerCtr(4) — Nashville, Tennessee, United States
- Novartis Investigative Site — Toronto, Ontario, Canada
- Novartis Investigative Site — Rotterdam, Netherlands
- Novartis Investigative Site — Rotterdam, Netherlands
- Novartis Investigative Site — Barcelona, Catalonia, Spain
Full record on ClinicalTrials.gov
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