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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01283503
First received: January 13, 2011
Last updated: April 4, 2012
Last verified: April 2012
History of Changes
  Purpose

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 Intervention Phase
Advanced Solid Tumor
 Drug: BKM120
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study of BKM120, Administered Orally in Adult Japanese Patients With Advanced Solid Tumors

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • establish Maximum tolerate dose (MTD) [ Time Frame: every day up to first 4 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Safety assessed by type, frequency and severity of adverse events [ Time Frame: Every week ] [ Designated as safety issue: Yes ]
  • Efficacy assessed by RECIST [ Time Frame: Every 2 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Measurement of biomarkers for PI3K pathway in blood and tissue [ Time Frame: First 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: October 2009
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BKM120 Drug: BKM120

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01283503

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

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01283503     History of Changes
Other Study ID Numbers: CBKM120X1101
Study First Received: January 13, 2011
Last Updated: April 4, 2012
Health Authority: United States: Food and Drug Administration
Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Novartis:
PI3K,
Advanced solid tumor

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on May 19, 2013