Preoperative administration of olaparib with or without cisplatin in patients who are candidates for surgery of carcinoma of the head and neck.

Phase 1

• Conditions: Histologically proven operable squamous cell carcinoma of the head and neck.; MedDRA version: 18.1 Level: PT Classification code 10060121 Term: Squamous cell carcinoma of head and neck System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-005268-41-GR
• Lead Sponsor: Hellenic Cooperative Oncology Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-03-24
• Last Update Posted: 1 February 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 39

Inclusion Criteria

1.Provision of signed written informed consent prior to any study specific procedures
2.Female and/or male patients aged 18 years and over
3.Newly diagnosed histologically proven squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx
4.Provision of biological material (tumor tissue and blood), provision of signed informed consent for translational research
5.Patients selected for a primary surgical treatment
6.No prior anti-cancer treatment for head and neck cancer
7.Performance status ECOG 0-1
8.Adequate hematological status: neutrophils (ANC) =1.5x109/L; platelets =100x109/L; haemoglobin =10g/dL
9.Adequate renal function: serum creatinine level 1.5 mg/dl and Glomelular Filtration Rate50 ml/min by Cockroft/Gault formula
10.Adequate liver function: serum bilirubin =1.5 x upper normal limit (ULN), alkaline phosphatase, AST, ALT 5xULN
11.No active rheumatoid arthritis, active inflammatory bowel disease, chronic infections, or any other disease or condition associated with chronic inflammation.
12.Ability to swallow tablets.
13.Regular follow-up feasible
14.Baseline evaluations performed before registration: clinical and blood evaluations no more than 1 week (7 days) prior to registration, tumour assessment (CT or MRI scan of the head and neck, chest, abdomen and pelvis at the discretion of the investigator) no more than 30 days prior to registration
15.Treatment initiation planned less than 1 week (7 days) after registration
16.For female patients of childbearing potential, negative serum pregnancy test within 1 week (7 days) prior of starting study treatment
17.Women of childbearing potential and their partners, who are sexually active, must agree to the use of TWO highly effective forms of contraception in combination, throughout the period of taking study treatment and for at least 1-6 month (according to the treatment group) after last dose of study drug(s) (where applicable). Male patients and their partners, who are sexually active and of childbearing potential, must agree to the use of TWO highly effective forms of contraception in combination, throughout the period of taking study treatment and for 3-6 months (according tot he treatment group) after last dose of study drug(s) (where applicable).

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 12
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 27

Exclusion Criteria

1. Metastatic or locally advanced unresectable disease
2.Uncontrolled hypercalcemia
3.Concomitant unplanned antitumour therapy (e.g. chemotherapy, molecular targeted therapy, immunotherapy)
4.Treatment with any other investigational medicinal product within 28 days prior to study entry
5.Other serious and uncontrolled non-malignant chronic disease
6.Treatment with CYP3A4 inhibitors as well as inducers, unless discontinued 7 days prior to randomization
7.Any of the following within 3 months prior to inclusion: grade 3-4 gastrointestinal bleeding, treatment resistant peptic ulcer disease, erosive esophagitis or gastritis, infectious or inflammatory bowel disease, or diverticulitis
8.Other concomitant or previous malignancy, except: i) adequately treated in-situ carcinoma of the uterine cervix, ii) basal or squamous cell carcinoma of the skin, iii) cancer in complete remission for 5 years
9.Any other serious and uncontrolled non-malignant disease, major surgery or traumatic injury within the last 28 days
10.Pregnant or breastfeeding women
11.Patients with known allergy to any excipients to study drugs
12.History of myocardial infarction and/or stroke or other arterial thrombotic events or pulmonary embolism or unstable angina pectoris within 6 months prior to registration
13.No features suggestive of MDS/ AML
14.Poorly controlled cardiac arrhythmias
15.Bowel obstruction
16.History of severe tumour bleeding or bleeding disorders
17.No blood transfusion within the 28 days prior to study
18.Poorly controlled anti-coagulation therapy (INR3.0 on coumadin or heparin compounds)
19.Palliative radiation therapy within 4 weeks prior to registration
20.Pregnancy or men or women of reproductive age not agreeing to use contraceptive measures

Study & Design

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