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

NCT01195376 | Completed Phase 1

• 1 other identifier: CBEZ235A1101
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Advanced Solid Tumor

Keywords

PI3K; mTOR; Advanced solid tumor

Outcome Measures

Primary Outcomes (1)

• To establish Maximum tolerate dose (MTD)

  Every week

Secondary Outcomes (4)

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

  Every week

• Efficacy assessed by RECIST

  Every 2 months

• To characterize the PK profiles

  Every 2 weeks

• To assess the biomarkers

  Every 2 months

Study Arms (2)

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

Interventions

BEZ235 DRUG

BEZ Dose escalation twice daily; BEZ235 Dose Escalation once daily

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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (2)

Novartis Investigative Site

Kobe, Hyōgo, 650-0017, Japan

Location

Novartis Investigative Site

Yufu, Oita Prefecture, 879-5593, Japan

Location

Related Publications (1)

• 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.

  PMID: 30446785 DERIVED

Related Links

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

MeSH Terms

Interventions

dactolisib

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: September 2, 2010
• First Posted: September 6, 2010
• Study Start: October 1, 2010
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: December 9, 2020

Record last verified: 2016-04

Locations

JP (2)