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A Phase IA, Multicenter, Open-label Dose Escalation Study of BKM120, Administered Orally in Adult Patients With Advanced Solid Malignancies


Phase 1
18 Years
N/A
Not Enrolling
Both
Breast Cancer, Colon Cancer, Ovarian Cancer, Endometrium Cancer

Thank you

Trial Information

A Phase IA, Multicenter, Open-label Dose Escalation Study of BKM120, Administered Orally in Adult Patients With Advanced Solid Malignancies


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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum Tolerated Dose (MTD) of BKM120

Outcome Time Frame:

throughout the study

Safety Issue:

Yes

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CBKM120X2101

NCT ID:

NCT01068483

Start Date:

November 2008

Completion Date:

August 2012

Related Keywords:

  • Breast Cancer
  • Colon Cancer
  • Ovarian Cancer
  • Endometrium Cancer
  • Advanced solid tumors
  • Breast Cancer
  • Colon Cancer
  • Ovarian Cancer
  • Endometrium cancer
  • Breast Neoplasms
  • Colonic Neoplasms
  • Ovarian Neoplasms
  • Endometrial Neoplasms

Name

Location

Sarah Cannon Research Institute Dept.ofSarahCannonCancerCtr(4)Nashville, Tennessee  37203