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

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ClinicalTrials.gov Identifier: NCT01095302
Recruitment Status : Completed
First Posted : March 30, 2010
Last Update Posted : October 16, 2013
Sponsor:
Information provided by (Responsible Party):
Sanofi

Tracking Information
First Submitted Date  ICMJE March 23, 2010
First Posted Date  ICMJE March 30, 2010
Last Update Posted Date October 16, 2013
Study Start Date  ICMJE May 2010
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 29, 2010)
Dose limiting toxicity [ Time Frame: 3 weeks (cycle 1) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01095302 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 5, 2011)
  • Global safety profile based on treatment emergent adverse events, serious adverse events, and laboratory abnormalities [ Time Frame: on-treatment period + 30 days ]
  • 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 ]
  • Objective tumor response as defined by the Response Evaluation Criteria in Solid Tumors (RECIST v1.1) [ Time Frame: on-treatment period + 30 days ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 29, 2010)
  • Global safety profile based on treatment emergent adverse events, serious adverse events, and laboratory abnormalities [ Time Frame: on-treatment period + 30 days ]
  • 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 ]
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dose Escalation, Safety and Pharmacokinetic Study of AVE8062 Combined With Docetaxel and Cisplatin in Patients With Solid Tumors
Official Title  ICMJE 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
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 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
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Neoplasms, Malignant
Intervention  ICMJE
  • Drug: OMBRABULIN (AVE8062)

    Pharmaceutical form:injection solution

    Route of administration: intravenous infusion

  • Drug: cisplatin

    Pharmaceutical form:injection solution

    Route of administration: intravenous infusion

  • Drug: docetaxel

    Pharmaceutical form:injection solution

    Route of administration: intravenous infusion

Study Arms  ICMJE Experimental: Ombrabulin/ docetaxel/cisplatin
AVE8062 combined with docetaxel and cisplatin will be administered once in every 3 weeks, with 30-minute intravenous infusion
Interventions:
  • Drug: OMBRABULIN (AVE8062)
  • Drug: cisplatin
  • Drug: docetaxel
Publications * Nishio M, Satouchi M, Horiike A, Horio Y, Sunaga Y, Ecstein-Fraisse E, Hida T. Phase 1 study of ombrabulin in combination with docetaxel and cisplatin in Japanese patients with advanced solid tumors. Jpn J Clin Oncol. 2018 Apr 1;48(4):322-328. doi: 10.1093/jjco/hyy026.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 15, 2011)
11
Original Estimated Enrollment  ICMJE
 (submitted: March 29, 2010)
12
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01095302
Other Study ID Numbers  ICMJE TCD11089
U1111-1116-5905 ( Other Identifier: UTN )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanofi
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Sciences & Operations Sanofi
PRS Account Sanofi
Verification Date October 2013

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