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

Phase 1

Completed

• Conditions: Advanced Solid Tumor
• Interventions: Drug: BKM120

• Registration Number: NCT01283503
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2011-01-13
• Study First Submitted QC: 2011-01-24
• Study First Posted: 2011-01-26
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2016-04
• Last Update Submitted: 2020-12-06
• Last Update Posted: 2020-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BKM120	BKM120	-

Primary Outcome Measures

Name	Time	Method
establish Maximum tolerate dose (MTD)	every day up to first 4 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Novartis Investigative Site; 🇯🇵 Kashiwa, Chiba, Japan