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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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

Condition or disease Intervention/treatment Phase
CINV Drug: Ondansetron Drug: Placebo Drug: Dexamethasone Drug: Fosaprepitant Drug: APD403 IV Drug: APD403 oral Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 342 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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 Start Date : October 2013
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Control
OND + DEX + FOS followed by oral DEX
Drug: Ondansetron
5HT3-antagonist

Drug: Dexamethasone
Corticosteroid

Drug: Fosaprepitant
NK1 antagonist

Placebo Comparator: Placebo
OND + PLACEBO followed by oral PLACEBO
Drug: Placebo
Comparator

Drug: APD403 IV
Amisulpride IV 20 mg

Experimental: Low dose APD403
OND + APD403 followed by oral APD403 low dose
Drug: Ondansetron
5HT3-antagonist

Drug: APD403 IV
Amisulpride IV 20 mg

Drug: APD403 oral
Amisulpride oral 10, 20 or 40 mg

Experimental: Mid dose APD403
OND + APD403 followed by oral APD403 mid dose
Drug: Ondansetron
5HT3-antagonist

Drug: APD403 IV
Amisulpride IV 20 mg

Drug: APD403 oral
Amisulpride oral 10, 20 or 40 mg

Experimental: High dose APD403
OND + APD403 followed by oral APD403 high dose
Drug: Ondansetron
5HT3-antagonist

Drug: APD403 IV
Amisulpride IV 20 mg

Drug: APD403 oral
Amisulpride oral 10, 20 or 40 mg




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01857232


Locations
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Denmark
Odense University Hospital
Odense, Denmark
Sponsors and Collaborators
Acacia Pharma Ltd
Investigators
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Principal Investigator: Jørn Herrstedt, MD Odense University Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Acacia Pharma Ltd
ClinicalTrials.gov Identifier: NCT01857232    
Other Study ID Numbers: DN10016
First Posted: May 20, 2013    Key Record Dates
Results First Posted: March 12, 2019
Last Update Posted: March 12, 2019
Last Verified: February 2019
Additional relevant MeSH terms:
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Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Dexamethasone
Ondansetron
Fosaprepitant
Aprepitant
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Anti-Anxiety Agents
Neurokinin-1 Receptor Antagonists