Skip to main content
Clinical Trials/NCT01283503
NCT01283503CompletedPhase 1

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

Novartis Pharmaceuticals1 site in 1 country15 target enrollmentStarted: October 2009Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
15
Locations
1
Primary Endpoint
establish Maximum tolerate dose (MTD)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
20 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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.
  • At least one measurable or non-measurable lesion as defined by RECIST guidelines for solid tumors.
  • Age ≥ 20 years
  • Eastern Cooperative Oncology Group Performance Status (ECOG P.S.) of ≤ 2
  • Life expectancy of ≥ 12 weeks
  • Patients must have the laboratory values

Exclusion Criteria

  • 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
  • Prior treatment with a PI3K inhibitor
  • Patients with any peripheral neuropathy ≥ CTCAE grade 2
  • Patients with unresolved diarrhea ≥ CTCAE grade 2
  • 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

Arms & Interventions

BKM120

Experimental

Intervention: BKM120 (Drug)

Outcomes

Primary Outcomes

establish Maximum tolerate dose (MTD)

Time Frame: every day up to first 4 weeks

Secondary Outcomes

  • Efficacy assessed by RECIST(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(Every 2 weeks up to first 4 weeks, then every odd cycle)
  • Measurement of biomarkers for PI3K pathway in blood and tissue(First 4 weeks)
  • Safety assessed by type, frequency and severity of adverse events(Every week)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

Loading locations...

Similar Trials