- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01095302
Dose Escalation, Safety and Pharmacokinetic Study of AVE8062 Combined With Docetaxel and Cisplatin in Patients With Solid Tumors
An Open-label, Dose-escalation, Safety and Pharmacokinetics Phase I Study of Ombrabulin in Combination With Docetaxel and Cisplatin 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 docetaxel and 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, docetaxel and cisplatin in combination.
- To evaluate anti-tumor activity of the combination therapy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
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Akashi-Shi, Japan
- Investigational Site Number 392003
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Koto-Ku, Japan
- Investigational Site Number 392001
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Nagoya-Shi, Japan
- Investigational Site Number 392002
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria:
- Patients with advanced solid tumor for which docetaxel and cisplatin is approved such as lung cancer, epithelial ovarian cancer.
Exclusion criteria:
- Eastern Cooperative Oncology Group performance status > or = 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 < or = 1 (or alopecia < or = 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
- Patients with more than 1 line of previous chemotherapy for advanced or metastatic disease (adjuvant/neoadjuvant and targeted agents [eg gefitinib] excluded).
- Current peripheral neuropathy > or = grade 2 and ototoxicity, of any origin including significant residual symptoms due to the use of neurotoxic drugs (eg vincaalkaloids, platinum and taxanes).
- 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 fundoscopic 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
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ombrabulin/ docetaxel/cisplatin
AVE8062 combined with docetaxel and cisplatin will be administered once in every 3 weeks, with 30-minute intravenous infusion
|
Pharmaceutical form:injection solution Route of administration: intravenous infusion 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 profiles of all study drugs and AVE8062 active metabolite based on PK parameters (Cmax, AUC, t1/2, CL, Vss).
Time Frame: Cycle 1: Day 1 and 3; up to Cycle 4: Day 1
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Cycle 1: Day 1 and 3; 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: on-treatment period + 30 days
|
on-treatment period + 30 days
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TCD11089
- U1111-1116-5905 (Other Identifier: UTN)
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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