Overview

Dose-finding Study of APD403 to Prevent Nausea and Vomiting After Chemotherapy

Status:
Completed
Trial end date:
2015-02-01
Target enrollment:
0
Participant gender:
All
Summary
Comparison of efficacy of APD403 at preventing delayed sickness in patients who have received cancer chemotherapy
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Acacia Pharma Ltd
Treatments:
Aprepitant
Dexamethasone
Fosaprepitant
Ondansetron
Criteria
Inclusion criteria

- Male or female patients ≥ 18 years of age

- Ability and willingness to give written informed consent

- Patients scheduled to receive, on day 1 of their chemotherapy, either: (i) a first
cisplatin chemotherapy infusion at a dose of ≥70 mg/m2 (males and females); or (ii) a
first infusion of cyclophosphamide at a dose of 500-1500 mg/m2 in combination with
either epirubicin at a dose of 60-100 mg/m2 or doxorubicin at a dose of 40-60 mg/m2
(females only)

- Karnofsky performance score ≥ 60%

- Adequate cardiac, hepatic and renal function

- QTc interval < 500 ms

- Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) < 5 x
upper limit normal (ULN)

- Bilirubin < 5 x ULN

- Creatinine < 3 x ULN

- Adequate haematological function

- Haemoglobin ≥ 8 g/dL

- White blood count ≥ 3.0 x 109/L

- Platelet count ≥ 100 x 109/L

- For females of child-bearing potential: ability and willingness to use a highly
effective form of contraception (e.g., abstinence from sexual intercourse, surgical
sterilisation (of subject or partner) or a double-barrier method of contraception such
as either an intra-uterine device (IUD) or an occlusive cap with spermicide, in
conjunction with partner's use of a condom) during the study and for a period of at
least 48 hours afterwards

Exclusion Criteria

- Patients scheduled to receive, prior to or in the 120 hours after cisplatin or AC, any
other chemotherapeutic agent with a high or moderate emetic risk

- Patients who have previously received anti-neoplastic chemotherapy

- Patients scheduled to receive paclitaxel or docetaxel during the first cycle of their
chemotherapy

- Patients undergoing abdominal or pelvic irradiation within 48 hours prior to screening
or scheduled to receive abdominal or pelvic irradiation between screening and 24 hours
after cisplatin or AC administration

- Patients with a known prolactin-dependent tumour (e.g. pituitary gland prolactinoma or
confirmed prolactin-dependent breast cancer) or phaeochromocytoma

- Patients with a pre-existing vestibular disorder

- Patients being treated with regular anti-emetic therapy including corticosteroids

- Patients receiving inhaled corticosteroids, unless started more than one month prior
to the expected date of study entry