A Study of BKM120 in Adult Japanese Patients With Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01283503
Recruitment Status : Completed
First Posted : January 26, 2011
Last Update Posted : April 21, 2016
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
In this study, BKM120 will be administered to adult patients with advanced solid tumors whose disease has progressed despite standard therapy or for whom no standard therapy exists. The trial will confirm the safety and tolerability and determine the maximum tolerated dose (MTD) of BKM120 in Japanese patients.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumor Drug: BKM120 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of BKM120, Administered Orally in Adult Japanese Patients With Advanced Solid Tumors
Study Start Date : October 2009
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Arm Intervention/treatment
Experimental: BKM120 Drug: BKM120

Primary Outcome Measures :
  1. establish Maximum tolerate dose (MTD) [ Time Frame: every day up to first 4 weeks ]

Secondary Outcome Measures :
  1. Safety assessed by type, frequency and severity of adverse events [ Time Frame: Every week ]
  2. Efficacy assessed by RECIST [ Time Frame: Every 2 months ]
  3. Establishment of a pharmacokinetic profile by collecting information on parameters including but not limited to Cmax, Tmax, T1/2 and AUC in plasma samples [ Time Frame: Every 2 weeks up to first 4 weeks, then every odd cycle ]
  4. Measurement of biomarkers for PI3K pathway in blood and tissue [ Time Frame: First 4 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patients with histologically confirmed, advanced unresectable solid tumors who have progressed on (or not been able to tolerate) standard therapy or for whom no standard anticancer therapy exists.
  2. At least one measurable or non-measurable lesion as defined by RECIST guidelines for solid tumors.
  3. Age ≥ 20 years
  4. Eastern Cooperative Oncology Group Performance Status (ECOG P.S.) of ≤ 2
  5. Life expectancy of ≥ 12 weeks
  6. Patients must have the laboratory values

Exclusion Criteria:

  1. Patients with a history of primary central nervous system tumors or brain metastases or who have signs/symptoms attribute to brain metastases and have not been assessed with radiologic imaging to rule out the presence of brain metastases
  2. Prior treatment with a PI3K inhibitor
  3. Patients with any peripheral neuropathy ≥ CTCAE grade 2
  4. Patients with unresolved diarrhea ≥ CTCAE grade 2
  5. Women of child-bearing potential who are pregnant or breast feeding. Men or women of reproductive potential not to sign informed consent for birth control. Barrier contraceptives must be used throughout the trial and six months after the end of treatment.

Other protocol-defined inclusion/exclusion criteria may apply

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01283503

Novartis Investigative Site
Nagoya-city, Aichi, Japan, 466-8560
Novartis Investigative Site
Kashiwa, Chiba, Japan, 277-8577
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Responsible Party: Novartis Pharmaceuticals Identifier: NCT01283503     History of Changes
Other Study ID Numbers: CBKM120X1101
First Posted: January 26, 2011    Key Record Dates
Last Update Posted: April 21, 2016
Last Verified: April 2016

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Advanced solid tumor