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

Neoplasms Clinical Trial

Official title:

Phase I Dose Escalation and Pharmacokinetic Study of SSR97225 Administered as a 1 Hour IV Infusion D1 Every 3 Weeks (Arm A) or Administered as a 1hour IV Infusion D1, D8, D15 Every 3 Weeks (Arm B) in Patients With Refractory Solid Tumors

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00547261
• Other study ID #: TED5710
• Status: Terminated
• Phase: Phase 1
• First received: October 18, 2007
• Last updated: April 16, 2009
• Start date: October 2007
• Est. completion date: August 2008

Study information

• Verified date: April 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasms

Intervention

Drug:
• SSR97225
every 3 weeks

Locations

Country	Name	City	State
United States	Sanofi-Aventis Administrative Office	Bridgewater	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximal tolerated dose (MTD) and dose limiting toxicity (DLT)		Study period	Yes
Secondary	Pharmacokinetic profile, antitumor activity in patients with measurable disease, effect of drug on CYP3A4 activity		Study period	No