Clinical trial NCT01857232: Dose-finding Study of APD403 to Prevent Nausea and Vomiting After Chemotherapy
Official title: Randomised, Double-blind, Dose-finding Phase II Study to Assess the Efficacy of APD403 in the Prevention of Nausea and Vomiting Caused by Cisplatin- or Anthracycline/Cyclophosphamide (AC)-Based Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: CINV
Lead sponsor: Acacia Pharma Ltd
Sponsor class: INDUSTRY
First posted: 2013-05-20
Enrollment: 342
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Comparison of efficacy of APD403 at preventing delayed sickness in patients who have received cancer chemotherapy


Eligibility 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

Primary outcomes:
measure: Number of Participants With Delayed Phase Complete Response(CR)
timeFrame: 24-120 hours
Secondary outcomes:
measure: Number of Participants With CR in the Overall Phase.
timeFrame: 0 to 120 hours after the initiation of chemotherapy
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
affiliation: Odense University Hospital
name: Jørn Herrstedt, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Herrstedt J, Summers Y, Jordan K, von Pawel J, Jakobsen AH, Ewertz M, Chan S, Naik JD, Karthaus M, Dubey S, Davis R, Fox GM. Amisulpride prevents nausea and vomiting associated with highly emetogenic chemotherapy: a randomised, double-blind, placebo-controlled, dose-ranging trial. Support Care Cancer. 2019 Jul;27(7):2699-2705. doi: 10.1007/s00520-018-4564-8. Epub 2018 Nov 28.