Phase I Dose Finding Study of SSR97225 Given in Patients... | NCT00547261

Studies
Phase I Dose Finding Study of SSR97225 Given in Patients With Refractory Cancer

NCT00547261

Sponsor

Sanofi

Status

Terminated

Last Update Posted

Apr 17, 2009Estimated

Enrollment

6Actual

Phase

Phase 1

Conditions

Neoplasms

Interventions

SSR97225

Countries

United States

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

Apr 2009

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Due to lack of supply of the investigational product.

Expanded Access Info

Start Date

Oct 2007

Primary Completion Date

Aug 2008Actual

Completion Date

Aug 2008Actual

First Submitted Date

Oct 18, 2007

First Submission Date that Met QC Criteria

Oct 18, 2007

First Posted Date

Oct 22, 2007Estimated

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

Apr 16, 2009

Last Update Posted Date

Apr 17, 2009Estimated

Description Module

Brief Summary

The purpose of this study is to determine the maximally tolerated dose and the dose limiting toxicity of this antimitotic, tubulin binding investigational drug for those patients who have failed standard anticancer treatments.

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

6Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm A	Experimental	1 hour IV infusion D1	Drug: SSR97225
Arm B	Experimental	1 hour IV infusion D1, D8, D15	Drug: SSR97225

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SSR97225	Drug	every 3 weeks	Arm A Arm B

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Maximal tolerated dose (MTD) and dose limiting toxicity (DLT)		Study period

Secondary Outcomes

Measure	Description	Time Frame
Pharmacokinetic profile, antitumor activity in patients with measurable disease, effect of drug on CYP3A4 activity		Study period

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of metastatic or locally advanced non-hematological cancer
Patients with solid tumors refractory to therapy or for whom no therapy exists

Exclusion Criteria:

Five or more prior chemotherapy lines for metastatic disease
Eastern Cooperative Oncology Group (ECOG) performance status >2
Patients having discontinued previous specific anti-cancer treatment
Patients who have not recovered from all toxic effects from previous specific anti-cancer treatment (excluding alopecia)
Patients with abnormal biological/hematological parameters, cardiac abnormalities or serious infection/intercurrent illness likely to jeopardize the patient's safety or the course of the protocol treatment
No adequate birth control methods

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
ICD CSD	Sanofi	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sanofi-Aventis Administrative Office		Bridgewater	New Jersey	08807	United States