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

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ClinicalTrials.gov Identifier: NCT01857232
Recruitment Status : Completed
First Posted : May 20, 2013
Results First Posted : March 12, 2019
Last Update Posted : March 12, 2019
Sponsor:
Information provided by (Responsible Party):
Acacia Pharma Ltd

Tracking Information
First Submitted Date  ICMJE May 16, 2013
First Posted Date  ICMJE May 20, 2013
Results First Submitted Date  ICMJE November 27, 2018
Results First Posted Date  ICMJE March 12, 2019
Last Update Posted Date March 12, 2019
Study Start Date  ICMJE October 2013
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 20, 2019)
Number of Participants With Delayed Phase Complete Response(CR) [ Time Frame: 24-120 hours ]
Delayed phase complete response (CR), defined as an absence of emetic episodes and no rescue medication use in the period from 24 to 120 hours after the initiation of chemotherapy. The primary endpoint was analysed separately in the strata of chemotherapy regimen and gender, and in the strata of country.
Original Primary Outcome Measures  ICMJE
 (submitted: May 17, 2013)
Complete Response [ Time Frame: 24-120 hours ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 20, 2019)
Number of Participants With CR in the Overall Phase. [ Time Frame: 0 to 120 hours after the initiation of chemotherapy ]
CR defined as no emesis and no use of rescue medication, in the overall phase (0 to 120 hours after the initiation of chemotherapy)
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dose-finding Study of APD403 to Prevent Nausea and Vomiting After Chemotherapy
Official Title  ICMJE 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
Brief Summary Comparison of efficacy of APD403 at preventing delayed sickness in patients who have received cancer chemotherapy
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE CINV
Intervention  ICMJE
  • Drug: Ondansetron
    5HT3-antagonist
  • Drug: Placebo
    Comparator
  • Drug: Dexamethasone
    Corticosteroid
  • Drug: Fosaprepitant
    NK1 antagonist
  • Drug: APD403 IV
    Amisulpride IV 20 mg
  • Drug: APD403 oral
    Amisulpride oral 10, 20 or 40 mg
Study Arms  ICMJE
  • Control
    OND + DEX + FOS followed by oral DEX
    Interventions:
    • Drug: Ondansetron
    • Drug: Dexamethasone
    • Drug: Fosaprepitant
  • Placebo Comparator: Placebo
    OND + PLACEBO followed by oral PLACEBO
    Interventions:
    • Drug: Placebo
    • Drug: APD403 IV
  • Experimental: Low dose APD403
    OND + APD403 followed by oral APD403 low dose
    Interventions:
    • Drug: Ondansetron
    • Drug: APD403 IV
    • Drug: APD403 oral
  • Experimental: Mid dose APD403
    OND + APD403 followed by oral APD403 mid dose
    Interventions:
    • Drug: Ondansetron
    • Drug: APD403 IV
    • Drug: APD403 oral
  • Experimental: High dose APD403
    OND + APD403 followed by oral APD403 high dose
    Interventions:
    • Drug: Ondansetron
    • Drug: APD403 IV
    • Drug: APD403 oral
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 20, 2019)
342
Original Estimated Enrollment  ICMJE
 (submitted: May 17, 2013)
315
Actual Study Completion Date  ICMJE February 2015
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01857232
Other Study ID Numbers  ICMJE DN10016
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Acacia Pharma Ltd
Study Sponsor  ICMJE Acacia Pharma Ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jørn Herrstedt, MD Odense University Hospital
PRS Account Acacia Pharma Ltd
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP