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OpenTrials
Completed

NCT Number: NCT01068483

Safety of BKM120 Monotherapy in Advanced Solid Tumor Patients

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.

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Key information

Conditions

Breast Cancer Adnexal Diseases Breast Diseases Breast Neoplasms Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Endometrial Neoplasms Endometrium Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Skin Diseases Skin and Connective Tissue Diseases Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novartis Investigative Site, Toronto, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BKM120

Drug

Primary outcomes

  1. Maximum Tolerated Dose (MTD) of BKM120

    Time frame: throughout the study

Secondary outcomes

  1. Safety and tolerability of BKM120

    Time frame: throughout the study

  2. Pharmacokinetics of BKM120

    Time frame: throughout the study

  3. Changes in tumor metabolic activity

    Time frame: throughout the study

  4. Pharmacodynamics of BKM120

    Time frame: throughout the study

  5. Clinical tumor response in patients with tumors that show PI3K pathway activation

    Time frame: throughout the study

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2011
Study completion
2012
First posted
Feb 15, 2010
Registry last updated
Dec 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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