Status:
COMPLETED
Dose-finding Study of APD403 to Prevent Nausea and Vomiting After Chemotherapy
Lead Sponsor:
Acacia Pharma Ltd
Conditions:
CINV
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Comparison of efficacy of APD403 at preventing delayed sickness in patients who have received cancer chemotherapy
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
342 Patients enrolled
Trial Details
Trial ID
NCT01857232
Start Date
October 1 2013
End Date
February 1 2015
Last Update
November 25 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Odense University Hospital
Odense, Denmark