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

NCT ID: NCT01195376

Last Updated: 2020-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2013-07-31

Brief Summary

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In this study, BEZ235 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 confirmed the safety and tolerability and determine the MTD of BEZ235 in Japanese patients.

Detailed Description

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Conditions

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Advanced Solid Tumor

Keywords

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PI3K mTOR Advanced solid tumor

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BEZ235 Dose Escalation once daily

oral BEZ235 once daily (q.d.)

Group Type EXPERIMENTAL

BEZ235

Intervention Type DRUG

BEZ Dose escalation twice daily

oral BEZ235 twice daily (b.i.d.)

Group Type EXPERIMENTAL

BEZ235

Intervention Type DRUG

Interventions

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BEZ235

Intervention Type DRUG

Eligibility Criteria

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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 lesion as defined by RECIST criteria for solid tumors.
3. Age ≥ 20
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 Patients in the expansion part of this study have to meet the following criteria in addition to the criteria described above.
7. Availability of a representative tumor tissue specimen (either archival tumor or fresh tumor biopsy) for pre-screening.
8. 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

1. 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
2. Patients with any peripheral neuropathy ≥ CTCAE grade 2
3. Patients with unresolved diarrhea ≥ CTCAE grade 2
4. Patients with a history of photosensitivity reactions to other drugs
5. 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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Kobe, Hyōgo, Japan

Site Status

Novartis Investigative Site

Yufu, Oita Prefecture, Japan

Site Status

Countries

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Japan

References

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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.

Reference Type DERIVED
PMID: 30446785 (View on PubMed)

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=11645

Results for CBEZ235A1101 can be found on the Novartis Clinical Trial Results Website

Other Identifiers

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CBEZ235A1101

Identifier Type: -

Identifier Source: org_study_id