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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01021150
Recruitment Status : Completed
First Posted : November 26, 2009
Last Update Posted : June 13, 2011
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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.

Condition or disease Intervention/treatment Phase
Neoplasms, Malignant Drug: ombrabulin (AVE8062) Drug: cisplatin Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : March 2010
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Cisplatin

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
Drug: ombrabulin (AVE8062)

Pharmaceutical form:injection solution

Route of administration: intravenous infusion

Drug: cisplatin

Pharmaceutical form: injection solution

Route of administration: intravenous infusion

Primary Outcome Measures :
  1. Dose limiting toxicity [ Time Frame: 3 weeks (cycle 1) ]

Secondary Outcome Measures :
  1. Global safety profile based on treatment emergent adverse events, serious adverse events, and laboratory abnormalities [ Time Frame: on-treatment period + 30 days ]
  2. Pharmacokinetic parameters of AVE8062 [ Time Frame: Cycle 1 : Day 1 and 2; up to Cycle 4 : Day 1 ]
  3. Pharmacokinetic parameters of cisplatin [ Time Frame: Day 1 to 4 of Cycle 1 ]
  4. Pharmacokinetic parameters of AVE8062's active metabolite RPR258063 [ Time Frame: Cycle 1 : Day 1 and 2; up to Cycle 4 : Day 1 ]
  5. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01021150

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Sanofi-Aventis Administrative Office
Tokyo, Japan
Sponsors and Collaborators
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Study Director: Clinical Sciences & Operations Sanofi
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Responsible Party: Trial Transparency Team, sanofi-aventis Identifier: NCT01021150    
Other Study ID Numbers: TCD11088
First Posted: November 26, 2009    Key Record Dates
Last Update Posted: June 13, 2011
Last Verified: June 2011
Additional relevant MeSH terms:
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Antineoplastic Agents