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

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

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00547261

Enrollment

Registered

2007-10-22

Start date

2007-10-31

Completion date

2008-08-31

Last updated

2009-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neoplasms

Keywords

solid tumor, antimitotic, tubulin binder

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.

Interventions

DRUGSSR97225

every 3 weeks

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026