- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01021150
Dose Escalation, Safety and Pharmacokinetic Study of AVE8062 Combined With Cisplatin in Patients With Solid Tumors
June 10, 2011 updated by: Sanofi
An Open Label, Dose Escalation, Safety and Pharmacokinetics Phase 1 Study With Ombrabulin Administered as a 30-minute Intravenous Infusion in Combination With Cisplatin Administered as an Intravenous Infusion Every 3 Weeks in Patients With Advanced Solid Tumors
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Anticipated)
12
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Tokyo, Japan
- Sanofi-Aventis Administrative Office
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Ombrabulin/cisplatin
AVE8062 combined with 75 mg/m2 of cisplatin will be administered once in every 3 weeks, with 30-minute intravenous infusion
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Pharmaceutical form:injection solution Route of administration: intravenous infusion Pharmaceutical form: injection solution Route of administration: intravenous infusion |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Dose limiting toxicity
Time Frame: 3 weeks (cycle 1)
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3 weeks (cycle 1)
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Global safety profile based on treatment emergent adverse events, serious adverse events, and laboratory abnormalities
Time Frame: on-treatment period + 30 days
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on-treatment period + 30 days
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Pharmacokinetic parameters of AVE8062
Time Frame: Cycle 1 : Day 1 and 2; up to Cycle 4 : Day 1
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Cycle 1 : Day 1 and 2; up to Cycle 4 : Day 1
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Pharmacokinetic parameters of cisplatin
Time Frame: Day 1 to 4 of Cycle 1
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Day 1 to 4 of Cycle 1
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Pharmacokinetic parameters of AVE8062's active metabolite RPR258063
Time Frame: Cycle 1 : Day 1 and 2; up to Cycle 4 : Day 1
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Cycle 1 : Day 1 and 2; up to Cycle 4 : Day 1
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Objective tumor response as defined by the Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
Time Frame: up to a maximum of 11 months
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up to a maximum of 11 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2010
Primary Completion (ACTUAL)
May 1, 2011
Study Completion (ACTUAL)
May 1, 2011
Study Registration Dates
First Submitted
November 24, 2009
First Submitted That Met QC Criteria
November 25, 2009
First Posted (ESTIMATE)
November 26, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
June 13, 2011
Last Update Submitted That Met QC Criteria
June 10, 2011
Last Verified
June 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TCD11088
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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