NCT00742105

Brief Summary

This study will confirm safety and tolerability and determine the MTD of BGT226 in Japanese patients with advanced solid tumor.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_1 cancer

Timeline
Completed

Started Nov 2008

Shorter than P25 for phase_1 cancer

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 27, 2008

Completed
3 months until next milestone

Study Start

First participant enrolled

November 17, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2009

Completed
Last Updated

September 25, 2018

Status Verified

September 1, 2018

Enrollment Period

1.1 years

First QC Date

August 25, 2008

Last Update Submit

September 21, 2018

Conditions

CancerSolid TumorAdvanced Solid Tumor

Keywords

PI3KmTORAdvanced solid tumorAdult

Outcome Measures

Primary Outcomes (1)

  • Incidence of dose limiting toxicity (DLT) at each dose level

    22-28 days

Secondary Outcomes (4)

  • Safety measured by type, frequency and severity of adverse drug reactions

    Every 4 weeks

  • Preliminary Efficacy od BGT226

    Every 8 weeks

  • Percent of patients in which an altered molecular status is detected for markers related to Pl3K signaling

    Baseline, every 3 weeks

  • Biomarkers: Percentage of change, pre- versus post-treatment

    Every month

Study Arms (1)

BGT226

EXPERIMENTAL
Drug: BGT226

Interventions

BGT226DRUG
BGT226

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • World Health Organization (WHO) Performance Status of ≤ 2
  • Histologically-confirmed, advanced solid tumors
  • Progressive, recurrent unresectable disease
  • Age ≥ 20

You may not qualify if:

  • Hematopoietic:
  • No diabetes mellitus or history of gestational diabetes mellitus
  • No acute or chronic renal disease
  • No acute or chronic liver disease
  • No acute or chronic pancreatitis
  • No impaired cardiac function or clinically significant cardiac diseases such as ventricular arrhythmia, congestive heart failure, uncontrolled hypertension
  • No acute myocardial infarction or unstable angina pectoris within the past 3 months
  • Not pregnant or nursing and fertile patients must use barrier contraceptives

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Novartis Investigative Site

Nagoya, Aichi-ken, 464-8681, Japan

Location

Novartis Investigative Site

Kobe, Hyōgo, 650-0017, Japan

Location

MeSH Terms

Conditions

Neoplasms

Interventions

8-(6-methoxypyridin-3-yl)-3-methyl-1-(4-piperazin-1-yl-3-trifluoromethylphenyl)-1,3-dihydroimidazo(4,5-c)quinolin-2-one

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

August 25, 2008

First Posted

August 27, 2008

Study Start

November 17, 2008

Primary Completion

December 22, 2009

Study Completion

December 22, 2009

Last Updated

September 25, 2018

Record last verified: 2018-09

Locations

JP(2)