A Phase 1 Study of ARQ 197 in Patients With Solid Tumors | NCT00609921

Studies
A Phase 1 Study of ARQ 197 in Patients With Solid Tumors

NCT00609921

Sponsor

Kyowa Kirin Co., Ltd.

Status

Completed

Last Update Posted

Sep 7, 2012Estimated

Enrollment

42Estimated

Phase

Phase 1

Conditions

Cancer

Interventions

ARQ197

Countries

Not provided

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

Sep 2012

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

Jan 2008

Primary Completion Date

Sep 2011Actual

Completion Date

Not provided

First Submitted Date

Jan 25, 2008

First Submission Date that Met QC Criteria

Jan 25, 2008

First Posted Date

Feb 7, 2008Estimated

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

Sep 6, 2012

Last Update Posted Date

Sep 7, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a Phase 1, open label, dose escalation study of ARQ 197 in patients with advanced/recurrent solid tumors. The purpose of this study is to determine the safety, tolerability and recommended Phase 2 dose (RP2D) of ARQ 197.

Detailed Description

Not provided

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

42Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	ARQ197	Drug: ARQ197

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ARQ197	Drug	treatment	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Determine the safety, tolerability and recommended Phase 2 dose (RP2D) of ARQ 197

Secondary Outcomes

Measure	Description	Time Frame
Assess the preliminary anti-tumor activity and determine the pharmacokinetic profile

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who did not respond or are refractory to available therapy or for whom no standard effective systemic therapy exists.
Karnofsky performance status (KPS) ≥ 70%, or Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
Patients with adequate organ function

Exclusion Criteria:

Anti-cancer chemotherapy, hormonal therapy, radiotherapy, immunotherapy, or investigational agents within 4 weeks prior to the first dose of ARQ 197
Known symptomatic brain metastases
Pregnant or breastfeeding
Uncontrolled intercurrent illness

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
Study Director	Kyowa Kirin Co., Ltd.	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C551661	ARQ 197

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided