A Phase I/IIa trial of AZD4547 in combination with Cisplatin and Capecitabine (CX) - A Phase I/IIa Trial of AZD4547 in combination with CX

Greater Glasgow Health Board0 sites158 target enrollmentSeptember 9, 2011

ConditionsStage 1 - Patients with advanced solid tumours.Stage 2 - Histologically proven adenocarcinoma or undifferentiated carcinoma of the oesophagus, gastro-oesophageal junction, or stomach.MedDRA version: 16.0Level: LLTClassification code 10065147Term: Malignant solid tumorSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 16.0Level: LLTClassification code 10030139Term: Oesophageal adenocarcinoma NOSSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 16.0Level: PTClassification code 10060139Term: Antineutrophil cytoplasmic antibody decreasedSystem Organ Class: 10022891 - Investigations MedDRA version: 16.0Level: PTClassification code 10001150Term: Adenocarcinoma gastricSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Stage 1 - Patients with advanced solid tumours.Stage 2 - Histologically proven adenocarcinoma or undifferentiated carcinoma of the oesophagus, gastro-oesophageal junction, or stomach.
Sponsor: Greater Glasgow Health Board
Enrollment: 158
Status: Active, not recruiting
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

September 9, 2011

End Date

TBD

Last Updated

10 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Greater Glasgow Health Board

Eligibility Criteria

Inclusion Criteria

•Inclusion Criteria (Stage 1 and Stage 2\)
•1\. Male/Female and over 25 years of age.
•2\. ECOG performance status 0, or 1 (Appendix 1\).
•3\. Written Informed Consent.
•4\. No chemotherapy, hormonal therapy, immunotherapy, targeted systemic cancer therapy, or investigational therapy within 4 weeks of study entry (6 weeks for mitomycin C and nitrosureas)
•5\. No radiotherapy within 4 weeks of study entry.
•6\. Adequate haematological function, as follows:
•\- Haemoglobin \> 10g/dl
•\- Neutrophils \> 1\.5 x 109/l
•\- Platelets \> 100 x 109/l

Exclusion Criteria

•Exclusion Criteria (Stage 1 and Stage 2\)
•1\. History of physical or psychiatric disorder that would prevent informed consent and compliance
•2\. Pregnant or lactating women.
•3\. Fertile woman of childbearing potential not willing to use adequate contraception (oral contraceptives, intrauterine device or barrier method of contraception in conjunction with spermicidal jelly or surgically sterile) for the study duration and at least six months afterwards. Fertile men who are not willing to use a barrier method of contraception (condoms with spermicidal jelly). Fertile men should also refrain from donating sperm from the start of dosing until 16 weeks after discontinuing study treatment. Male patients wishing to subsequently father children should attend for freezing of sperm samples prior to dosing. It is not known whether AZD4547 can induce hepatic enzymes. If oral contraception is used, it is recommended that this is used in combination with a barrier method as well.
•4\. Evidence of uncontrolled infection (defined as infection that cannot be resolved readily with antibiotics prior to patient entry into the trial)
•5\. Major surgery within 28 days prior to study entry or anticipated to occur while on study
•6\. Prolonged QTc (corrected) interval of \> 470ms on ECG or a family history of long QT syndrome
•7\. History of active or treated brain metastases (with the exception of patients with resected brain metastases and no evidence of recurrence on CT or MRI of the brain)
•8\. CNS disease (uncontrolled seizures or cerebrovascular accident/transient ischaemic attack /subarachnoid haemorrhage within 6 months)
•9\. Any unresolved toxicity \> CTC Grade 1 from previous systemic anti\-cancer therapy except alopecia