Ph II Nintedanib vs. Ifosfamide in Soft Tissue Sarcoma (ANITA)
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|ClinicalTrials.gov Identifier: NCT02808247|
Recruitment Status : Terminated (Exceed of pre-specified number of failures in the experimental arm)
First Posted : June 21, 2016
Last Update Posted : September 20, 2021
This is a prospective, multicentric, randomized, open label Phase II trial investigating whether the oral angiogenesis inhibitor nintedanib, as compared to the intravenous cytotoxic compound ifosfamide, given for patients with advanced, inoperable and/or metastatic STS after failure of first line chemotherapy prolongs progression-free survival.
The primary objective of the trial is to evaluate whether nintedanib given as second-line therapy for advanced, inoperable and/or metastatic STS prolongs progression-free survival when compared with ifosfamide.
Secondary objectives are to evaluate the efficacy of nintedanib as compared to ifosfamide in terms of progression-free survival rate at 12 weeks, overall survival, objective response rate, patient benefit rate, response duration, total duration of treatment with nintedanib safety, Health related Quality of Life and Health Economics.
Exploratory objectives include an analysis of putative predictive biomarkers for the anti-tumor effects of the investigational agent nintedanib.treatment.
|Condition or disease||Intervention/treatment||Phase|
|Sarcoma, Soft Tissue||Drug: Nintedanib Drug: Ifosfamide||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Multicenter Study Comparing the Efficacy of the Oral Angiogenesis Inhibitor Nintedanib With the Intravenous Cytotoxic Compound Ifosfamide for Treatment of Patients With Advanced Metastatic Soft Tissue Sarcoma After Failure of Systemic Non-oxazaphosporine-based First Line Chemotherapy for Inoperable Disease "ANITA"|
|Actual Study Start Date :||July 7, 2017|
|Actual Primary Completion Date :||November 3, 2020|
|Actual Study Completion Date :||April 14, 2021|
Experimental: Experimental arm (arm A): Nintedanib
Nintedanib 200 mg twice daily orally. Nintedanib will be given continuously until clinically relevant disease progression according to the investigator's assessment or until other criteria for treatment discontinuation are met as specified in the protocol. Dosing beyond RECIST 1.1 progression is allowed for the oral agent if the patient still derives benefit from the treatment.
Pharmaceutical form: Soft gelatine capsule Pharmaceutical code: Nintedanib (BIBF1120) Source: Boehringer Ingelheim Pharma GmbH & Co. KG Unit strength: 100 mg and 150 mg capsules Daily dose: 400 mg (200 mg twice daily p.o.) Route of administration: oral
Other Name: BIBF1120
Active Comparator: Standard arm (arm B): Ifosfamide
Ifosfamide 3 g/m2 intravenously on days 1, 2 and 3 every 21 days for up to a maximum of 6 cycles.
Ifosfamide will be given at a dose of 3 g/m2 intravenously on days 1, 2 and 3 every 21 days. The total dose per cycle is 9 g/m2
- progression-free survival (PFS) [ Time Frame: 4 years from first patient in ]progression-free survival (PFS) defined according to RECIST 1.1.
- Progression-free survival rate at 12 weeks (binary) [ Time Frame: 4 years from first patient in ]
- Overall survival [ Time Frame: 4 years from first patient in ]
- Objective response rate [ Time Frame: 4 years from first patient in ]Objective tumor response as defined by RECIST 1.1
- Clinical benefit rate [ Time Frame: 4 years from first patient in ]
- Response duration [ Time Frame: 4 years from first patient in ]Duration of response will be measured for patients achieving an objective response
- Total duration of treatment with nintedanib (including treatment beyond RECIST progression) [ Time Frame: 4 years from first patient in ]
- Safety (Common Toxicity Criteria CTCAE 4.0) [ Time Frame: 4 years from first patient in ]
- Health related quality of life (QLQ-C30) [ Time Frame: 4 years from first patient in ]Quality of life will be assessed with the EORTC QoL Questionnaire (QLQ-C30) version 3.0
- Health economics (EQ-5D-5L, health care resource utilities) [ Time Frame: 4 years from first patient in ]Patient reported utility: EQ-5D-5L
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 ClinicalTrials.gov identifier (NCT number): NCT02808247
|Hopitaux Universitaires Bordet-Erasme - Institut Jules Bordet|
|Brussels, Belgium, 1000|
|Cliniques Universitaires Saint-Luc (121)|
|U.Z. Leuven - Campus Gasthuisberg (147)|
|Bordeaux, France, 33076|
|Centre Leon Berard (227)|
|Gustave Roussy (225)|
|Vilnius University Hospital Santariskiu Santaros Clinics Klinikos (9453)|
|Vilnius, Lithuania, 08661|
|The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis (301)|
|Amsterdam, Netherlands, 1066|
|Leiden University Medical Centre (310)|
|Leiden, Netherlands, 2300|
|Maria Sklodowska-Curie Memorial Cancer Centre|
|Warsaw, Poland, 02 781|
|Institut Catala d'Oncologia - ICO Badalona - Hospital Germans Trias i Pujol (Institut Catala D'Oncologia)|
|Barcelona, Spain, 08916|
|Hospital Universitario San Carlos (366)|
|Madrid, Spain, 28040|
|Royal Marsden Hospital - Chelsea, London (613)|
|London, United Kingdom, SW3 6JJ|
|Principal Investigator:||Patrick Schoeffski, MD||U.Z. Leuven - Campus Gasthuisberg (147)|