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

NCT01283503 | Completed Phase 1

• 1 other identifier: CBKM120X1101
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

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.

Conditions

Advanced Solid Tumor

Keywords

PI3K,; Advanced solid tumor

Outcome Measures

Primary Outcomes (1)

• establish Maximum tolerate dose (MTD)

  every day up to first 4 weeks

Secondary Outcomes (4)

• Safety assessed by type, frequency and severity of adverse events

  Every week

• 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

Study Arms (1)

BKM120

EXPERIMENTAL

Drug: BKM120

Interventions

BKM120 DRUG

BKM120

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (2)

Novartis Investigative Site

Nagoya, Aichi-ken, 466-8560, Japan

Location

Novartis Investigative Site

Kashiwa, Chiba, 277-8577, Japan

Location

Related Links

• Results for CBKM120X1101 can be found on the Novartis Clinical Trial Results Website

MeSH Terms

Interventions

NVP-BKM120

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2011
• First Posted: January 26, 2011
• Study Start: October 1, 2009
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: December 8, 2020

Record last verified: 2016-04

Locations

JP (2)