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

Advanced Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01283503
• Other study ID #: CBKM120X1101
• Status: Completed
• Phase: Phase 1
• Start date: October 2009
• Est. completion date: October 2011

Study information

• Verified date: April 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Neoplasms

Intervention

Drug:
• BKM120

Locations

Country	Name	City	State
Japan	Novartis Investigative Site	Kashiwa	Chiba
Japan	Novartis Investigative Site	Nagoya-city	Aichi

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	establish Maximum tolerate dose (MTD)		every day up to first 4 weeks
Secondary	Safety assessed by type, frequency and severity of adverse events		Every week
Secondary	Efficacy assessed by RECIST		Every 2 months
Secondary	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
Secondary	Measurement of biomarkers for PI3K pathway in blood and tissue		First 4 weeks

External Links

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