Dose-finding Study of APD403 to Prevent Nausea and Vomiting After Chemotherapy
NCT ID: NCT01857232
Last Updated: 2020-11-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
342 participants
INTERVENTIONAL
2013-10-31
2015-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Control
OND + DEX + FOS followed by oral DEX
Ondansetron
5HT3-antagonist
Dexamethasone
Corticosteroid
Fosaprepitant
NK1 antagonist
Placebo
OND + APD403 followed by oral PLACEBO
Ondansetron
5HT3-antagonist
Placebo
Comparator
APD403 IV
Amisulpride IV 20 mg
Low dose APD403
OND + APD403 followed by oral APD403 low dose
Ondansetron
5HT3-antagonist
APD403 IV
Amisulpride IV 20 mg
APD403 oral
Amisulpride oral 10, 20 or 40 mg
Mid dose APD403
OND + APD403 followed by oral APD403 mid dose
Ondansetron
5HT3-antagonist
APD403 IV
Amisulpride IV 20 mg
APD403 oral
Amisulpride oral 10, 20 or 40 mg
High dose APD403
OND + APD403 followed by oral APD403 high dose
Ondansetron
5HT3-antagonist
APD403 IV
Amisulpride IV 20 mg
APD403 oral
Amisulpride oral 10, 20 or 40 mg
Interventions
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Ondansetron
5HT3-antagonist
Placebo
Comparator
Dexamethasone
Corticosteroid
Fosaprepitant
NK1 antagonist
APD403 IV
Amisulpride IV 20 mg
APD403 oral
Amisulpride oral 10, 20 or 40 mg
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Acacia Pharma Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Jørn Herrstedt, MD
Role: PRINCIPAL_INVESTIGATOR
Odense University Hospital
Locations
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Odense University Hospital
Odense, , Denmark
Countries
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References
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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.
Other Identifiers
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DN10016
Identifier Type: -
Identifier Source: org_study_id