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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01293630
First received: February 8, 2011
Last updated: November 27, 2013
Last verified: November 2013

February 8, 2011
November 27, 2013
December 2010
November 2013   (final data collection date for primary outcome measure)
The number of of drug related adverse events meeting the defined dose limiting toxicity at Cycle 1 [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01293630 on ClinicalTrials.gov Archive Site
  • The number of treatment emergent adverse events [ Time Frame: 30 days after the last injection ] [ Designated as safety issue: Yes ]
  • The number of serious adverse events [ Time Frame: 30 days after the last injection ] [ Designated as safety issue: Yes ]
  • The number of laboratory abnormalities [ Time Frame: 30 days after the last injection ] [ Designated as safety issue: Yes ]
  • Pharmacokinetic parameter of ombrabulin: Cmax [ Time Frame: Day 1-2 at Cycle 1 ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameter of RPR258063: tmax [ Time Frame: Day 1-2 at Cycle 1 ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameter of paclitaxel: Cmax [ Time Frame: Day 1-3 at Cycle 1 ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameter of carboplatin (free and total platinum): Cmax [ Time Frame: Day 1-3 at Cycle 1 ] [ Designated as safety issue: No ]
  • Investigator determination of response [ Time Frame: 30 days after the last injection ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameter of ombrabulin: AUC [ Time Frame: Day 1-2 at Cycle 1 ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameter of ombrabulin: CL [ Time Frame: Day 1-2 at Cycle 1 ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameter of ombrabulin: Vss [ Time Frame: Day 1-2 at Cycle 1 ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameter of ombrabulin: t 1/2 [ Time Frame: Day 1-2 at Cycle 1 ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameter of RPR258063: Cmax [ Time Frame: Day 1-2 at Cycle 1 ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameter of RPR258063: AUC [ Time Frame: Day 1-2 at Cycle 1 ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameter of RPR258063: t 1/2 [ Time Frame: Day 1-2 at Cycle 1 ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameter of RPR258063: Metabolic Ratio [ Time Frame: Day 1-2 at Cycle 1 ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameter of paclitaxel: AUC [ Time Frame: Day 1-3 at Cycle 1 ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameter of paclitaxel: CL [ Time Frame: Day 1-3 at Cycle 1 ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameter of paclitaxel: Vss [ Time Frame: Day 1-3 at Cycle 1 ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameter of paclitaxel: t 1/2 [ Time Frame: Day 1-3 at Cycle 1 ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameter of carboplatin (free and total platinum): AUC [ Time Frame: Day 1-3 at Cycle 1 ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameter of carboplatin (free and total platinum): CL [ Time Frame: Day 1-3 at Cycle 1 ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameter of carboplatin (free and total platinum): Vss [ Time Frame: Day 1-3 at Cycle 1 ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameter of carboplatin (free and total platinum): t 1/2 [ Time Frame: Day 1-3 at Cycle 1 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Dose-escalation Study of Ombrabulin in Combination With Paclitaxel and Carboplatin in Patients With Advanced Solid Tumors
An Open-label, Dose-escalation, Safety and Pharmacokinetics Phase I Study of Ombrabulin in Combination With Paclitaxel and Carboplatin Every 3 Weeks in Patients With Advanced Solid Tumors

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

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.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Advanced Solid Tumors
  • Drug: Ombrabulin (AVE8062)

    Pharmaceutical form:solution

    Route of administration: intravenous

  • Drug: Paclitaxel

    Pharmaceutical form:solution

    Route of administration: intravenous

  • Drug: Carboplatin

    Pharmaceutical form:solution

    Route of administration: intravenous

Experimental: Cohort - 1 through 5
AVE8062 combined with paclitaxel and carboplatin will be administered once every 3 weeks
Interventions:
  • Drug: Ombrabulin (AVE8062)
  • Drug: Paclitaxel
  • Drug: Carboplatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
November 2013
November 2013   (final data collection date for primary outcome measure)

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.

Both
20 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01293630
TCD11270, U1111-1115-2568
No
Sanofi
Sanofi
Not Provided
Study Director: Clinical Sciences & Operations Sanofi
Sanofi
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP