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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01486251
Other study ID # 2011-001151-37
Secondary ID 2011/1738
Status Completed
Phase N/A
First received October 31, 2011
Last updated February 9, 2016
Start date September 2011
Est. completion date September 2014

Study information

Verified date February 2016
Source Gustave Roussy, Cancer Campus, Grand Paris
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate and quantify the dynamic modifications of tumor blood perfusion on axitinib therapy in patients with refractory mCRC for each dose of Axitinib.


Recruitment information / eligibility

Status Completed
Enrollment 27
Est. completion date September 2014
Est. primary completion date April 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients with histologically confirmed diagnosis of CRC

- Measurable metastatic disease to the liver in proven disease progression (according to RECIST criteria) at baseline (within 4 weeks prior to study entry), with at least one lesion > 2cm considered appropriate for DCE-US examination

- Previously exposed to at least, irinotecan, oxaliplatin and a fluoropyrimidine, all 3 administered at optimal doses, over one or two chemotherapy (CT) lines for metastatic disease with a clear resistance to these drugs. Previous exposure to bevacizumab and/or anti-EGFR monoclonal antibody is allowed.

- Age =18 years; Performance Status (PS) 0-2 and life expectancy > 3 months.

- Adequate biological functions: Neutrophils = 1.5 x 109/L; Platelets = 100 x 109/L; Hemoglobin > 9 g/dl; Creatinine clearance > 30 ml/min (cockcroft & Gault formula). Serum bilirubin < 1,5 x the upper normal limit (UNL) and AST/ALT < 5 x UNL.

- Signed written informed consent

- Female patients with childbearing potential (<2 years after last menstruation) and male must use effective means of contraception during the study treatment and at least 6 months after the last study drug administration.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Drug:
axitinib
Axitinib will be given BID orally. The 3 dose levels tested will be: 1st cycle: 5 mg BID; 2nd cycle: 7 mg BID; 3rd cycle: 10 mg BID. One cycle is defined as a 14-day period (7 days ON / 7 days OFF). Patients will receive a first cycle of single agent axitinib at the starting dose with DCE-US assessment. If no study treatment-related adverse event (AE) of grade > 1 is observed during this cycle, intrapatient dose escalation will be performed for the second cycle. The same dose escalation method wil apply between the 2d and 3d cycles.

Locations

Country Name City State
France Institut gustave roussy Villejuif

Sponsors (1)

Lead Sponsor Collaborator
Gustave Roussy, Cancer Campus, Grand Paris

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Echography measure Variation of the total area under the curve (tAUC) measured by DCE-US in the region of interest (ROI) between baseline and the end of each axitinib cycle at increasing dose. baseline and on day 2, day 7, day 15, day 29, day 35 and day 43 No
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