A Study of BEZ235 in Adult Japanese Patients With Advance... | NCT01195376

Studies
A Study of BEZ235 in Adult Japanese Patients With Advanced Solid Tumors

NCT01195376

Sponsor

Novartis Pharmaceuticals

Status

Completed

Last Update Posted

Dec 9, 2020Actual

Enrollment

35Actual

Phase

Phase 1

Conditions

Advanced Solid Tumor

Interventions

BEZ235

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2010

Primary Completion Date

Jul 2013Actual

Completion Date

Jul 2013Actual

First Submitted Date

Sep 2, 2010

First Submission Date that Met QC Criteria

Sep 3, 2010

First Posted Date

Sep 6, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 6, 2020

Last Update Posted Date

Dec 9, 2020Actual

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

35Actual

Label	Type	Description	Intervention Names
BEZ235 Dose Escalation once daily	Experimental	oral BEZ235 once daily (q.d.)	Drug: BEZ235
BEZ Dose escalation twice daily	Experimental	oral BEZ235 twice daily (b.i.d.)	Drug: BEZ235

Name	Type	Description	Arm Group Labels	Other Names
BEZ235	Drug		BEZ Dose escalation twice daily BEZ235 Dose Escalation once daily

Measure	Description	Time Frame
To establish Maximum tolerate dose (MTD)		Every week

Measure	Description	Time Frame
Safety assessed by type, frequency and severity of adverse events		Every week
Efficacy assessed by RECIST		Every 2 months
To characterize the PK profiles

Eligibility Module

Eligibility Criteria

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 lesion as defined by RECIST criteria for solid tumors.
Age ≥ 20
Eastern Cooperative Oncology Group Performance Status (ECOG P.S.) of ≤ 2
Life expectancy of ≥ 12 weeks
Patients must have the laboratory values Patients in the expansion part of this study have to meet the following criteria in addition to the criteria described above.
Availability of a representative tumor tissue specimen (either archival tumor or fresh tumor biopsy) for pre-screening.
Patients whose molecular status proved to meet the criteria (PIK3CA mutation/amplification and/or PTEN mutation and/or low/null PTEN expression) during pre-screening.

Exclusion Criteria:

Patients who have brain metastases or who have signs/symptoms attributable and have not been assessed with radiologic imaging to rule out the presence of brain metastases
Patients with any peripheral neuropathy ≥ CTCAE grade 2
Patients with unresolved diarrhea ≥ CTCAE grade 2
Patients with a history of photosensitivity reactions to other drugs
Women of child-bearing potential who are pregnant or breast feeding or adults of reproductive potential not employing an effective method of birth control. Barrier contraceptives must be used throughout the trial in both sexes. Women of child-bearing potential, defined as sexually mature women who have not undergone a hysterectomy or who have not been naturally postmenopausal for at least consecutive 1 years (i.e., who has had menses any time in the preceding consecutive 2 years), must have a negative serum pregnancy test ≤ 7 days prior to starting BEZ235.

Other protocol-defined inclusion/exclusion criteria may apply

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigative Site		Kobe	Hyōgo	650-0017	Japan
Novartis Investigative Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30446785	Derived	Toyoda M, Watanabe K, Amagasaki T, Natsume K, Takeuchi H, Quadt C, Shirao K, Minami H. A phase I study of single-agent BEZ235 special delivery system sachet in Japanese patients with advanced solid tumors. Cancer Chemother Pharmacol. 2019 Feb;83(2):289-299. doi: 10.1007/s00280-018-3725-2. Epub 2018 Nov 16.