A Study to Investigate the Disposition of Radio-labeled AVE8062 Compound Administered as a 30-minute IV Infusion to Patients With Advanced Solid Tumor

NCT01063946 | Completed Phase 1

• 2 other identifiers: BEX65872008-007824-24
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objectives:

• To determine the excretion balance and systemic exposure of radioactivity after intravenous infusion of \[14C\]-AVE8062 to humans
• To determine the pharmacokinetics of AVE8062 and RPR258063 and their contribution to overall exposure
• To collect samples to determine the metabolic pathways of AVE8062 and identify the chemical structures of the main metabolites Secondary Objective:
• To assess the safety profile of the drug

Conditions

Neoplasms, Malignant

Outcome Measures

Primary Outcomes (2)

• Percentage of radioactive dose excreted in urine, feces and expired air

  3 weeks (end of cycle 1) or 30 days after the first dose

• Concentration-time profiles and pharmacokinetic (PK) parameters of total radioactivity in whole blood and plasma; blood over plasma concentration ratios; Concentration-time profile and PK parameters of AVE8062 and RPR258063 in plasma

  3 weeks (end of cycle 1) or 30 days after the first dose

Secondary Outcomes (1)

• Safety assessment based on Adverse events reporting, laboratory tests according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTC) v3.0 grade scaling

  3 weeks (end of cycle 1) or 30 days after the first dose

Study Arms (1)

[14C]-AVE8062

EXPERIMENTAL

Single, 30 minute, intravenous infusion of 25 mg/m² of \[14C\]-AVE8062 containing 1.85 MBq (50µCi) at the first cycle, followed by subsequent administrations with non-radiolabelled AVE8062 in combination with cisplatin every 3 weeks, according to the investigator's judgment.

Drug: Ombrabulin (AVE8062)

Interventions

Ombrabulin (AVE8062) DRUG

Pharmaceutical form:concentrate solution Route of administration: intravenous infusion

[14C]-AVE8062

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with advanced neoplastic disease that has become refractory to conventional treatment or for which no standard therapy exists.
• Age = or \> 18 years
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
• Adequate hematological, hepatic and renal functions

You may not qualify if:

• Poor metabolizers for CYP2C19, CYP2C9, CYP2D6 and polymorphic UGTs will be excluded from the study
• The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis Administrative Office

Brussels, Belgium

Location

MeSH Terms

Conditions

Neoplasms

Interventions

AC 7700

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2010
• First Posted: February 5, 2010
• Study Start: January 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: September 1, 2011
• Last Updated: December 21, 2011

Record last verified: 2011-12

Locations

BE (1)