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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Neoplasms

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Maximal tolerated dose (MTD) and dose limiting toxicity (DLT)

Outcome Time Frame:

Study period

Safety Issue:

Yes

Principal Investigator

ICD CSD

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

United States: Food and Drug Administration

Study ID:

TED5710

NCT ID:

NCT00547261

Start Date:

October 2007

Completion Date:

August 2008

Related Keywords:

  • Neoplasms
  • solid tumor
  • antimitotic
  • tubulin binder
  • Neoplasms

Name

Location

Sanofi-Aventis Administrative OfficeBridgewater, New Jersey  08807