NCT00034281

Brief Summary

The purpose of this study is to investigate a safe dose of TAK-165, once daily (QD), in patients with HER2-tumor expression.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jun 2002

Geographic Reach
1 country

4 active sites

Status
completed

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

April 24, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 25, 2002

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2002

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2003

Completed
Last Updated

February 2, 2012

Status Verified

January 1, 2012

Enrollment Period

1.3 years

First QC Date

April 24, 2002

Last Update Submit

January 31, 2012

Conditions

Breast NeoplasmPancreatic NeoplasmLung NeoplasmOvarian NeoplasmRenal Neoplasm

Keywords

Gene, HER2Clinical Trial, Phase IBreast neoplasmPancreatic neoplasmOvarian neoplasmColorectal neoplasmRenal neoplasmProstate neoplasmCancer

Outcome Measures

Primary Outcomes (3)

  • Dose Limiting Toxicity

    Days 8, 15, 22, 28 and every 14 days thereafter to Final Visit

  • Maximum Tolerated Dose

    Days 8, 15, 22, 28 and every 14 days thereafter to Final Visit

  • Optimal Dosing for Phase II Studies.

    End of Study.

Secondary Outcomes (2)

  • Clinical Pharmacokinetic Profile of TAK-165

    Days 8, 15, 22, 28 and every 14 days thereafter to Final Visit

  • Response Evaluation Criteria in Solid Tumors Documentation of Objective Tumor Response.

    Day 56

Study Arms (1)

TAK-165 QD

EXPERIMENTAL
Drug: TAK-165

Interventions

TAK-165DRUG

Starting dose of TAK-165 10 mg, tablets, orally, once daily with dose escalation to tolerability for 56 days.

TAK-165 QD

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have advanced or metastatic cancer which is refractory to standard therapy or subjects for whom there is no known effective therapy.
  • Have a histologically or cytologically proven diagnosis of a solid tumor known to express HER2.
  • Have a predicted life expectancy of greater than or equal to 12 weeks.
  • Have a Karnofsky Performance Status of greater than or equal to 60%
  • Have recovered from toxicities of prior chemotherapy, surgery, or radiotherapy.

You may not qualify if:

  • Be pregnant or lactating. Women of childbearing potential must have a negative serum pregnancy test result within 7 days of enrollment into the study. Male and female subjects of childbearing potential (including women who have been amenorrheic for less than 1 year) must use appropriate birth control during the entire duration of the study, or the subject must be surgically sterile.
  • Have symptomatic brain metastasis
  • Have received any other anti-cancer treatment or investigational drug/treatment within 28 days prior to study Day 1.
  • Have a history of another malignancy within the last 5 years.
  • Have inadequate organ function.
  • Have heart failure defined by an ejection fraction of less than or equal to 50% as measured by MUGA.
  • Have Class II, III or IV symptoms of heart failure as defined by the New York Heart Association, or uncontrolled arrhythmias, or recent history of myocardial infarction or angina pectoris.
  • Have a medical condition that may interfere with intake and/or absorption of the study drug (e.g., gastrectomy or resection of major portion of small intestine).
  • Have any other serious disease or condition present at screening or at study Day 1 that might affect life expectancy or make it difficult to successfully manage and follow the subject according to the protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Arizona Cancer Center

Scottsdale, Arizona, 85258, United States

Location

The Institute for Drug Development

San Antonio, Texas, 78229, United States

Location

Brooke Army Medical Center/Drug Development Unit

San Antonio, Texas, 78234, United States

Location

South Texas VA, Audie Murphy Division

San Antonio, Texas, 78284, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsPancreatic NeoplasmsLung NeoplasmsOvarian NeoplasmsKidney NeoplasmsColorectal NeoplasmsProstatic NeoplasmsNeoplasms

Interventions

TAK-165

Condition Hierarchy (Ancestors)

Neoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesDigestive System NeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesGonadal DisordersUrologic NeoplasmsKidney DiseasesUrologic DiseasesMale Urogenital DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesGenital Neoplasms, MaleGenital Diseases, MaleProstatic Diseases

Study Officials

  • Medical Director

    Takeda

    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

April 24, 2002

First Posted

April 25, 2002

Study Start

June 1, 2002

Primary Completion

September 1, 2003

Study Completion

September 1, 2003

Last Updated

February 2, 2012

Record last verified: 2012-01

Locations

US(4)