udwig

Phase 1

• Conditions: Oesophageal Cancer; MedDRA version: 20.0Level: LLTClassification code 10026180Term: Malignant neoplasm of oesophagusSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-005298-19-GB
• Lead Sponsor: udwig Institute for Cancer Research Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-01-28
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

1.Histological diagnosis of oesophageal or gastrooesophageal cancer. Have not received full dose systemic chemotherapy.
- Cohorts A and B - metastatic/locally advanced cancer
- Cohorts C and D/D2 - deemed suitable for surgery with curative intent
2.Recovered from prior therapy (Grade 1 persistent AEs acceptable)
3.Anticipated lifespan greater than 4 months
4.ECOG performance status of 0 or 1
5.At the time of day 1 of the study, subjects with brain metastases must be asymptomatic and show evidence that their CNS disease is not progressing
6.Adequate normal organ and marrow function as defined in detail in the protocol
7.Written informed consent obtained from the subject prior to performing any protocol-related procedures, including screening evaluations
8.Age =18 years
9.Have been informed of other treatment options
10. Willing and able to comply with the protocol for the duration of the study including undergoing treatment, scheduled visits, examinations, biopsies and follow up
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 55
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

1.Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site). Previous enrollment in the present study.
2.Participation in another clinical study with an investigational product within 4 weeks prior to Day 1 of the study; resolution of respective adverse event to Grade 1 or lower should have occurred.
3.Mean QT interval corrected for heart rate (QTc) =470 ms
4.Active or prior documented autoimmune disease within the past 2 years
5.Active or prior documented inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis)
6.History of allogeneic organ transplant
7.Uncontrolled intercurrent illness
8.Known history of previous clinical diagnosis of tuberculosis
9.Prior exposure to tremelimumab / durvalumab or checkpoint inhibitors
10.History of severe allergic reactions to any unknown allergens or any components of the study drugs.
11.Known dihydropyrimidine dehydrogenase (DPD) deficiency
12.Treatment with sorivudine or its chemically related analogues, such as brivudine
13.Peripheral sensitive neuropathy with functional impairment
14.History of sarcoidosis syndrome.
15.Metastatic disease to the central nervous system for which other therapeutic options, including radiotherapy, may be available.
16.History of pneumonitis or interstitial lung disease.
17.Major surgical procedure (as defined by the investigator) within 30 days prior to Day 1 or still recovering from prior surgery.
18.Women who are breast feeding or pregnant
19.Any condition that, in the clinical judgment of the treating physician, is likely to interfere with evaluation of study treatment, interpretation of subject safety or study results, prevent the subject from complying with any aspect of the protocol or that may put the subject at unacceptable risk.
20.Subjects should not donate blood while participating in this study
21.For oxaliplatin, capecitabine, paclitaxel, carboplatin, 5-fluorouracil, leucovorin, docetaxel: refer to prescribing information for additional information

Study & Design

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