A Dose-escalation Study of Ombrabulin in Combination With Paclitaxel and Carboplatin in Patients With Advanced Solid Tumors

NCT ID: NCT01293630

Last Updated: 2015-10-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2013-10-31

Brief Summary

The primary objective of the study is to determine the maximum tolerated dose (MTD) based on the incidence of dose limiting toxicity (DLT) and the maximum administered dose (MAD) of ombrabulin combined with paclitaxel and carboplatin administered every 3 weeks in patients with advanced solid tumors.

Secondary Objectives:

• To assess the overall safety profiles of the combination therapy
• To characterize the pharmacokinetic profile of ombrabulin, its active metabolite RPR 258063, paclitaxel, and carboplatin when used in combination
• To document the objective tumor response

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.

Conditions

Advanced Solid Tumors

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort - 1 through 5

AVE8062 combined with paclitaxel and carboplatin will be administered once every 3 weeks

Group Type: EXPERIMENTAL

Ombrabulin (AVE8062)

Intervention Type: DRUG

Pharmaceutical form:solution

Route of administration: intravenous

Paclitaxel

Intervention Type: DRUG

Pharmaceutical form:solution

Route of administration: intravenous

Carboplatin

Intervention Type: DRUG

Pharmaceutical form:solution

Route of administration: intravenous

Interventions

Ombrabulin (AVE8062)

Pharmaceutical form:solution

Route of administration: intravenous

Intervention Type: DRUG

Paclitaxel

Pharmaceutical form:solution

Route of administration: intravenous

Intervention Type: DRUG

Carboplatin

Pharmaceutical form:solution

Route of administration: intravenous

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients with advanced solid tumor for which the combination paclitaxel and carboplatin is potentially effective such as lung cancer, epithelial ovarian cancer.
• Patients who have signed and dated an Institutional Review Board (IRB)-approved patient informed consent form prior to study enrollment or performance of any study-specific procedures.

Exclusion Criteria

• Less than 20 or above 75 years of age ECOG performance status ≥2.
• Patients with more than 1 line of previous chemotherapy for advanced or metastatic disease (adjuvant/neoadjuvant and targeted agents [eg gefitinib] excluded)
• Concurrent treatment with any other anticancer therapy (except palliative radiotherapy),
• Women of childbearing potential who does not agree with contraception.
• Washout period of less than 28 days from prior anticancer therapies
• Symptomatic brain metastases and carcinomatous leptomeningitis.
• Other serious illness or medical conditions
• Current peripheral neuropathy ≥grade 2 and ototoxicity,
• Absolute neutrophils counts<1.5 x 10E9/L. - Platelets count<100 x 10E9/L. - hemoglobin <9.0 g/dL (without red blood cell transfusion within 28 days before the test). - Creatinine Clearance<55 mL/min. - Total bilirubin >upper normal limits of the institutional norms. - ALT/AST >1.5 times the upper normal limits of the institutional norms. - AP>2.5 times the upper normal limits of the institutional norms.
• Medical history of myocardial infarction, angina pectoris, congestive heart failure, coronary artery bypass graft , arrhythmia , stroke or history of arterial or venous thrombo-embolism within the past 180 days requiring anticoagulants.
• Patient with a LVEF <50% by echocardiography.
• 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.
• Hypertension defined as systolic BP >140 mmHg or diastolic BP >90 mmHg on two repeated measurements at 30 minutes interval.

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Investigational Site Number 392002

Akashi-Shi, , Japan

Investigational Site Number 392001

Hidaka-Shi, , Japan

Countries

Japan

References

Matsumoto K, Sunaga Y, Ecstein-Fraisse E, Fujiwara K. Phase I study of ombrabulin in combination with paclitaxel and carboplatin in Japanese patients with advanced solid tumors. Int J Gynecol Cancer. 2024 Apr 1;34(4):586-593. doi: 10.1136/ijgc-2022-003880.

Reference Type: DERIVED

PMID: 37989482 (View on PubMed)

Other Identifiers

U1111-1115-2568

Identifier Type: OTHER

Identifier Source: secondary_id

TCD11270

Identifier Type: -

Identifier Source: org_study_id