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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


Phase 2
18 Years
N/A
Not Enrolling
Both
CINV

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Trial Information

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

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

Complete Response

Outcome Time Frame:

24-120 hours

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

DN10016

NCT ID:

NCT01857232

Start Date:

Completion Date:

Related Keywords:

  • CINV

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