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

December 6, 2020 updated by: Novartis Pharmaceuticals

A Phase I Study of BKM120, Administered Orally in Adult Japanese Patients With Advanced Solid Tumors

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Aichi
      • Nagoya-city, Aichi, Japan, 466-8560
        • Novartis Investigative Site
    • Chiba
      • Kashiwa, Chiba, Japan, 277-8577
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BKM120
Drug: BKM120

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
establish Maximum tolerate dose (MTD)
Time Frame: every day up to first 4 weeks
every day up to first 4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety assessed by type, frequency and severity of adverse events
Time Frame: Every week
Every week
Efficacy assessed by RECIST
Time Frame: Every 2 months
Every 2 months
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
Every 2 weeks up to first 4 weeks, then every odd cycle
Measurement of biomarkers for PI3K pathway in blood and tissue
Time Frame: First 4 weeks
First 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

January 13, 2011

First Submitted That Met QC Criteria

January 24, 2011

First Posted (Estimate)

January 26, 2011

Study Record Updates

Last Update Posted (Actual)

December 8, 2020

Last Update Submitted That Met QC Criteria

December 6, 2020

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CBKM120X1101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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