Chemotherapy-induced Nausea and VomitingPhase 2NCT01303978
Phase II Proof-of-concept Study of APD421
A Phase 2 study testing APD421 in people with Chemotherapy-induced Nausea and Vomiting, run by Acacia Pharma Ltd at 4 sites in 2 countries.
Trial summary
Evaluation of efficacy of APD421 in preventing nausea and vomiting caused by cisplatin Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy-induced Nausea and Vomiting
- What is being tested?
- APD421
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Feb 2011to Jul 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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, a first cisplatin chemotherapy infusion at a dose of 50 mg/m2 or greater
- Karnofsky performance score ≥ 60%
- Adequate cardiac, hepatic and renal function
- QTc interval < 500 ms
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- Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) < 5 x upper limit normal (ULN)
- Bilirubin < 3 x ULN
- Creatinine < 2 x ULN
- Adequate haematological function
- Haemoglobin ≥ 9 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.
Who cannot join
- 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.
- Patients scheduled to receive paclitaxel or docetaxel
- 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
- Patients receiving APD421 for any indication within the last 2 weeks
- Patients who are allergic to APD421 or any of the excipients of APD421
- Patients with a pre-existing vestibular disorder
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- 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
- 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
- Patients being treated with xxx
- Patients receiving benzodiazepines, unless on a stable dose for at least one month prior to the expected date of study entry
- Patients with pre-existing nausea or vomiting in the 24 hours before receiving cisplatin chemotherapy, e.g. anticipatory emesis
- Patients who are pregnant or breast feeding
- Patients with a history of alcohol abuse
- Patients with pre-existing, clinically significant cardiac arrhythmia
- Any other concurrent disease or illness that, in the opinion of the investigator makes the patient unsuitable for the study
- Patients who have participated in another study within the previous 28 days
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Denmark3 sites
Herlev Hospital
Copenhagen
Rigshospitalet
Copenhagen
Odense University Hospital
Odense
United Kingdom1 site
University Hospital of South Manchester NHS Trust
Manchester
About this study
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
Evaluation of efficacy of APD421 in preventing nausea and vomiting caused by cisplatin
- Conditions
- Chemotherapy-induced Nausea and Vomiting
- Being tested
- APD421
- Medical subject headings
- Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APD421Drug
Single dose
| Study group | Role | What they receive |
|---|---|---|
| APD421 starting dose | Experimental | Not described Receives: Drug: APD421 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response
No emesis or use of rescue medication
Measured: 24 hours after cisplatin dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-induced Nausea and VomitingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acacia Pharma Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01303978
- Sponsor's protocol ID
- DN10007
- Status last verified
- Sep 2012
- First submitted
- 24 Feb 2011
- Last updated
- 25 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01303978
- Acronym / sponsor ID
- DN10007
- Conditions
- Chemotherapy-induced Nausea and Vomiting
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Acacia Pharma LtdIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 25 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of efficacy of APD421 in preventing nausea and vomiting caused by cisplatin
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| APD421 starting dose | Experimental | Drug: APD421 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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, a first cisplatin chemotherapy infusion at a dose of 50 mg/m2 or greater
- Karnofsky performance score ≥ 60%
- Adequate cardiac, hepatic and renal function
Key exclusion criteria (17 listed)
- 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.
- Patients scheduled to receive paclitaxel or docetaxel
- 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
- Patients receiving APD421 for any indication within the last 2 weeks
- Patients who are allergic to APD421 or any of the excipients of APD421
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| APD421Single dose | Drug | APD421 starting dose |
Primary outcome
Complete Response
Time frame: 24 hours after cisplatin dosing
No emesis or use of rescue medication
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing APD421 in people with Chemotherapy-induced Nausea and Vomiting, run by Acacia Pharma Ltd at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Denmark, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Response (time frame: 24 hours after cisplatin dosing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2012.