Dose Escalation, Safety and Pharmacokinetic Study of AVE8062 Combined With Cisplatin in Patients With Solid Tumors

NCT01021150 | Completed Phase 1

• 1 other identifier: TCD11088
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objective:

• To determine the maximum tolerated dose based on the incidence of dose limiting toxicity and the maximum administered dose of ombrabulin in combination with cisplatin administered every 3 weeks in patients with advanced solid tumors. Secondary Objectives:
• To assess the overall safety profile of the combination therapy.
• To characterize the pharmacokinetic profile of ombrabulin, its active metabolite RPR 258063, and cisplatin in combination.
• To evaluate anti-tumor activity of the combination therapy.

Conditions

Neoplasms, Malignant

Outcome Measures

Primary Outcomes (1)

• Dose limiting toxicity

  3 weeks (cycle 1)

Secondary Outcomes (5)

• Global safety profile based on treatment emergent adverse events, serious adverse events, and laboratory abnormalities

  on-treatment period + 30 days

• Pharmacokinetic parameters of AVE8062

  Cycle 1 : Day 1 and 2; up to Cycle 4 : Day 1

• Pharmacokinetic parameters of cisplatin

  Day 1 to 4 of Cycle 1

• Pharmacokinetic parameters of AVE8062's active metabolite RPR258063

  Cycle 1 : Day 1 and 2; up to Cycle 4 : Day 1

• Objective tumor response as defined by the Response Evaluation Criteria in Solid Tumors (RECIST v1.1)

  up to a maximum of 11 months

Study Arms (1)

Ombrabulin/cisplatin

EXPERIMENTAL

AVE8062 combined with 75 mg/m2 of cisplatin will be administered once in every 3 weeks, with 30-minute intravenous infusion

Drug: ombrabulin (AVE8062); Drug: cisplatin

Interventions

ombrabulin (AVE8062) DRUG

Pharmaceutical form:injection solution Route of administration: intravenous infusion

Ombrabulin/cisplatin

cisplatin DRUG

Pharmaceutical form: injection solution Route of administration: intravenous infusion

Ombrabulin/cisplatin

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Advanced solid tumor that has become refractory to conventional treatment or for which no standard therapy exists.

You may not qualify if:

• Eastern Cooperative Oncology Group performance status ≥ 2.
• Concurrent treatment with any other anticancer therapy
• Male or female patients who do not agree with contraception.
• Washout period of less than 28 days from prior anticancer therapies (chemotherapy, targeted agents, immunotherapy and radiotherapy) or any investigational treatment, except for nitrosoureas, mitomycin which may not be used up to 42 days prior to the first cycle.No washout period is required for hormonal therapy that has to be discontinued before the first cycle.
• Not recovered from all previous therapies (radiation, surgery, and medications). Adverse events related to previous therapies must be National Cancer Institute Common Terminology Criteria (NCI-CTCAE V3.0) grade≤1 (or alopecia≤grade 2) at screening or returned to the subject's baseline prior to their most recent previous therapy.
• Symptomatic brain metastases and carcinomatous leptomeningitis.
• Other serious illness or medical conditions not controlled by adequate treatment
• Previous cumulative carboplatin dose higher than 3,000 mg/m2 or cisplatin higher than 600 mg/m2.
• Patients whose disease has progressed or has recurred in less than 6 months from the completion of the previous platinum containing chemotherapy
• Known platinum compound hypersensitivity.
• Neuropathy and ototoxicity due to previous platinum chemotherapy.
• Inadequate organ function
• Documented medical history of myocardial infarction, documented angina pectoris, arrhythmia especially severe conduction disorder such as second or third degree atrio-ventricular block, stroke, or history of arterial or venous thrombo-embolism within the past 180 days requiring anticoagulants.
• Patient with a left ventricular ejection fraction\<50% by echocardiography.
• Patients with a baseline QTc interval\>0.45, or family history of Long QT Syndrome.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis Administrative Office

Tokyo, Japan

Location

MeSH Terms

Conditions

Neoplasms

Interventions

AC 7700; Cisplatin

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

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

Study Record Dates

• First Submitted: November 24, 2009
• First Posted: November 26, 2009
• Study Start: March 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: June 13, 2011

Record last verified: 2011-06

Locations

JP (1)