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-NL
• Lead Sponsor: European Organisation for Research and Treatment of Cancer

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-01-25
• Last Update Posted: 5 April 2021

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 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 <2 x ULN and prothrombin time and activated partial thromboplastin time < 1.5 x ULN in the absence of therapeutic anticoagulation
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 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 the last 4 weeks with any investigational drug, radiotherapy, immunotherapy, chemotherapy, hormonal therapy or biological therapy. Palliative radiotherapy may be permitted for symptomatic control of pain from bone metastases in extremities, provided that the radiotherapy does not affect target lesions, and the reason for the radiotherapy does not reflect progressive disease.
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).
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 leptomeningealcarcinomatosis.
9.Known, uncontrolled hypersensitivity to the investigational drugs or their excipients.
10.Significant cardiovascular diseases, including uncontrolled hypertension, clinically relevant cardiac arrhythmia, unstable angina or myocardial infarction within 6 months prior to enrolment, congestive heart failure > NYHA III, severe peripheral vascular disease, clinically significant pericardial effusion.
11.History of major thromboembolic event defined as:
•pulmonary embolism (PE) within six months prior to enrolment
•recurrent pulmonary embolism (history of at least 2 events)
•history of at least 2 unprovoked (=without a transient reversible risk factor) events of proximal deep venous thrombosis
•history of a provoked (=with transient or reversible risk factor, such as surgery) thrombosis of proximal deep veins or visceral vessels within 6 months prior to enrolment if not on stable therapeutic anticoagulation.
12.Prior thrombosis or thromboembolic event in the presence of an inherited coagulopathy (including deficiency of antithrombin, deficiency of protein C or protein S, Factor V Leiden mutation, Prothrombin G20210A mutation).
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 si

Study & Design

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