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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01021150
Other study ID # TCD11088
Secondary ID
Status Completed
Phase Phase 1
First received November 24, 2009
Last updated June 10, 2011
Start date March 2010
Est. completion date May 2011

Study information

Verified date June 2011
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Interventional

Clinical Trial 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.


Description:

The duration of the study for each patient will include an up to 4-week screening phase, 21-day study treatment cycles, an end of treatment visit and a follow-up period 30 days after the last infusion of ombrabulin. The patient will continue treatment until disease progression, unacceptable toxicity, patient's refusal of further treatment.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date May 2011
Est. primary completion date May 2011
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 75 Years
Eligibility Inclusion criteria :

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

Exclusion criteria :

- 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.

- Patient with uncontrolled hypertension and patient with organ damage related to hypertension such as left ventricular hypertrophy or grade 2 ocular fundscopic changes or kidney impairment.

- Patients with growing vessel disease (eg age-related macular degeneration, diabetic retinopathy, rheumatoid arthritis), or ongoing wound healing process. Patients should be enrolled in the study at least 28 days after surgery

- 12-lead Electrocardiogram: ST- and T-wave changes suggesting ischemia

- Hypertension defined as systolic blood pressure (BP)>140 mmHg or diastolic BP>90 mmHg on two repeated measurements at 30 minutes intervals.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
ombrabulin (AVE8062)
Pharmaceutical form:injection solution Route of administration: intravenous infusion
cisplatin
Pharmaceutical form: injection solution Route of administration: intravenous infusion

Locations

Country Name City State
Japan Sanofi-Aventis Administrative Office Tokyo

Sponsors (1)

Lead Sponsor Collaborator
Sanofi

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Dose limiting toxicity 3 weeks (cycle 1) Yes
Secondary Global safety profile based on treatment emergent adverse events, serious adverse events, and laboratory abnormalities on-treatment period + 30 days Yes
Secondary Pharmacokinetic parameters of AVE8062 Cycle 1 : Day 1 and 2; up to Cycle 4 : Day 1 No
Secondary Pharmacokinetic parameters of cisplatin Day 1 to 4 of Cycle 1 No
Secondary Pharmacokinetic parameters of AVE8062's active metabolite RPR258063 Cycle 1 : Day 1 and 2; up to Cycle 4 : Day 1 No
Secondary Objective tumor response as defined by the Response Evaluation Criteria in Solid Tumors (RECIST v1.1) up to a maximum of 11 months No
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