iCCC - A Randomised Phase II Study Of Nintedanib (BIBF1120) Compared To Chemotherapy in Patients With Recurrent Clear Cell Carcinoma Of The Ovary Or Endometrium

Phase 1

• Conditions: Recurrent clear cell carcinoma of the ovary or endometrium; MedDRA version: 21.1Level: PTClassification code 10009252Term: Clear cell endometrial carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: PTClassification code 10066697Term: Ovarian cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-002109-73-GB
• Lead Sponsor: Greater Glasgow Health Board

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-12-09
• Last Update Posted: 14 December 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

1.Progressive or recurrent ovarian peritoneal or fallopian tube clear cell carcinoma, or progressive or recurrent endometrial clear cell carcinoma. The primary diagnosis must be histologically confirmed and central pathological review of the presenting tumour or biopsy of relapsed disease must find at least 50% clear cell carcinoma with no serous differentiation. Progressive disease as defined by RECIST 1.1
2.Failure after =1 prior platinum containing regimen which may have been given in the adjuvant setting. For patients with ovarian clear cell carcinoma, progression must have occurred within 6 calendar months of their last platinum dose.
3.ECOG Performance status of =2
4.Life expectancy of >3 months
5.Adequate hepatic, bone marrow coagulation and renal function
a.Hepatic function: total bilirubin< ULN; ALT and AST < 2.5 x ULN
b.Coagulation parameters: INR or prothrombin ratio or percentage <2 x ULN and
activated partial thromboplastin time < 1.5 x ULN
c.Absolute neutrophil count (ANC) =1.5 x 109/L
d.Platelets = 100 x 109L
e.Haemoglobin = 9.0 g/dL
f.Proteinuria < grade 2 (CTCAE version 4)
g.Glomerular Filtration Rate =40ml/min. (calculated using the Wright, Cockroft & Gault equation or measured by EDTA clearance)
6.Female and > 18 years of age
7.Signed and dated written informed consent prior to admission to the study in accordance with ICH-GCP guidelines and local legislation.
8.Willingness and ability to comply with scheduled visits, treatment plans and laboratory tests and other study procedures.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 84
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 36

Exclusion Criteria

1.Prior treatment with Nintedanib or other angiogenesis inhibitor/VEGF targeted therapy, except for prior treatment with bevacizumab which is permitted.
2.Treatment within 28 days prior to randomisation with any investigational drug, radiotherapy, immunotherapy, chemotherapy, hormonal therapy or biological therapy. Single fraction palliative radiotherapy may be permitted for symptomatic control of pain from bone metastases, provided that the radiotherapy does not affect target lesions, and the reason for the radiotherapy does not reflect progressive disease. Longer courses of palliative radiotherapy must be discussed with the Chief Investigator in the first instance.
3.Previous treatment with the chemotherapy regimen selected as the control arm by the investigator. (Prior therapy with paclitaxel given on a three weekly regimen is permitted for patients receiving weekly Paclitaxel. Prior treatment with weekly paclitaxel is permitted where this has been used as part of first line therapy and it is greater than 6 months since the last dose of weekly paclitaxel. Prior weekly paclitaxel for relapsed disease is not permitted).
4.Other malignancy diagnosed within 5 years of enrolment except for:
a.Non-melanomatous skin cancer (if adequately treated)
b.Cervical carcinoma in situ (if adequately treated)
c.Carcinoma in situ of the breast (if adequately treated)
d.For patients with ovarian clear cell cancer, prior or synchronous endometrial cancer (if adequately treated), provided all of the following criteria are met:
•Disease stage FIGO Stage 1a (tumour invades less than one half of myometrium)
•Grade 1 or 2
5.Patients with any other severe concurrent disease, which may increase the risk associated with study participation or study drug administration and, in the judgement of the investigator, would make the patient inappropriate for entry into this study, including significant neurologic, psychiatric, infectious, hepatic, renal, or gastrointestinal diseases or laboratory abnormality.
6.Symptoms or signs of gastrointestinal obstruction requiring parenteral nutrition or hydration or any other gastro-intestinal disorders or abnormalities, including difficulty swallowing, that would interfere with drug absorption.
7.Serious infections in particular if requiring systemic antibiotic (antimicrobial, antifungal) or antiviral therapy, including known hepatitis B and/or C infection and HIV-infection.
8.Symptomatic CNS metastasis or leptomeningeal carcinomatosis
9.Known, uncontrolled hypersensitivity to the investigational drugs or their excipients.
10.Hypersensitivity to Nintedanib, peanut or soya, or to any of the excipients of Nintedanib.
11.Significant cardiovascular diseases, including uncontrolled hypertension, clinically relevant cardiac arrhythmia, unstable angina or myocardial infarction within 6 months prior to randomisation, congestive heart failure > NYHA III, severe peripheral vascular disease or clinically significant pericardial effusion.
12.History of major thromboembolic event within the last 6 months, such as pulmonary embolism or proximal deep vein thrombosis, unless stable on therapeutic coagulation. Warfarin is not permitted on the study. LMWH is recommended for therapeutic anticoagulation.
13. Known inherited predisposition to bleeding or thrombosis.
14.History of a cerebral vascular accident, transient ischemic attack or subarachnoid haemorrhage within the past 6 months.
15.History of clinically significan

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified