Phase II Proof-of-concept Study of APD421

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Acacia Pharma Ltd
ClinicalTrials.gov Identifier:
NCT01303978
First received: February 24, 2011
Last updated: September 21, 2012
Last verified: September 2012
  Purpose

Evaluation of efficacy of APD421 in preventing nausea and vomiting caused by cisplatin


Condition Intervention Phase
Chemotherapy-induced Nausea and Vomiting
Drug: APD421
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Open-label, Ascending-dose, Phase II Study to Determine the Minimum Effective Dose of APD421 in the Prevention of Cisplatin-induced Nausea and Vomiting

Resource links provided by NLM:


Further study details as provided by Acacia Pharma Ltd:

Primary Outcome Measures:
  • Complete Response [ Time Frame: 24 hours after cisplatin dosing ] [ Designated as safety issue: No ]
    No emesis or use of rescue medication


Enrollment: 51
Study Start Date: February 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: APD421 starting dose Drug: APD421
Single dose

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female patients ≥ 18 years of age
  2. Ability and willingness to give written informed consent
  3. Patients scheduled to receive, on day 1 of their chemotherapy, a first cisplatin chemotherapy infusion at a dose of 50 mg/m2 or greater
  4. Karnofsky performance score ≥ 60%
  5. 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 < 3 x ULN
    • Creatinine < 2 x ULN
  6. Adequate haematological function

    • Haemoglobin ≥ 9 g/dL
    • White blood count ≥ 3.0 x 109/L
    • Platelet count ≥ 100 x 109/L
  7. 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:

  1. Patients scheduled to receive, prior to or in the 24 hours after cisplatin, any chemotherapeutic agent with a high or moderate emetic risk, see Appendix 4.
  2. Patients scheduled to receive paclitaxel or docetaxel
  3. 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 administration
  4. Patients receiving APD421 for any indication within the last 2 weeks
  5. Patients who are allergic to APD421 or any of the excipients of APD421
  6. Patients with a pre-existing vestibular disorder
  7. Patients being treated with regular anti-emetic therapy including corticosteroids
  8. Patients receiving inhaled corticosteroids, unless started more than one month prior to the expected date of study entry
  9. Patients being treated with medications which could induce torsades de pointes, including Class Ia antiarrhythmic agents such as quinidine, disopyramide, procainamide; Class III antiarrhythmic agents such as amiodarone and sotalol; and other medications such as bepridil, cisapride, thioridazine, methadone, IV erythromycin, IV vincamine, halofantrine, pentamidine, sparfloxacin
  10. Patients being treated with xxx
  11. Patients receiving benzodiazepines, unless on a stable dose for at least one month prior to the expected date of study entry
  12. Patients with pre-existing nausea or vomiting in the 24 hours before receiving cisplatin chemotherapy, e.g. anticipatory emesis
  13. Patients who are pregnant or breast feeding
  14. Patients with a history of alcohol abuse
  15. Patients with pre-existing, clinically significant cardiac arrhythmia
  16. Any other concurrent disease or illness that, in the opinion of the investigator makes the patient unsuitable for the study
  17. Patients who have participated in another study within the previous 28 days
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01303978

Locations
Denmark
Herlev Hospital
Copenhagen, Denmark
Rigshospitalet
Copenhagen, Denmark
Odense University Hospital
Odense, Denmark
United Kingdom
University Hospital of South Manchester NHS Trust
Manchester, United Kingdom
Sponsors and Collaborators
Acacia Pharma Ltd
  More Information

No publications provided

Responsible Party: Acacia Pharma Ltd
ClinicalTrials.gov Identifier: NCT01303978     History of Changes
Other Study ID Numbers: DN10007
Study First Received: February 24, 2011
Last Updated: September 21, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Denmark: Danish Medicines Agency

Additional relevant MeSH terms:
Nausea
Vomiting
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on October 30, 2014