CancerPhase 1NCT01224730
A Food Effect and QTc Study of Perifosine in Patients With Advanced Malignancies
A Phase 1 study testing perifosine in people with Cancer, run by AEterna Zentaris at 2 sites in United States.
Trial summary
This is a Phase I study which will analyze any food-drug effects as well as QTc effects of perifosine. Safety and efficacy will also be evaluated. Patients who complete the first 24 days on single agent perifosine may have the opportunity to 1) continue on single agent perifosine; 2) switch to the combination of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- perifosine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesUnited States
- Study dates
- 24 Jan 2012to 4 Nov 2013
- Phase
- Phase 1
- 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
- Patients with advanced malignancies
- Patients with adequate organ and marrow function
Who cannot join
- Patients previously treated with perifosine
- Patients receiving any other chemotherapy, targeted agents, investigational agents or devices within four weeks (28 days) prior to Day 1 of study treatment
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Study site
Dallas, Texas, 75230
Study site
Houston, Texas, 77030
About this study
This is a Phase I study which will analyze any food-drug effects as well as QTc effects of perifosine. Safety and efficacy will also be evaluated.
Patients who complete the first 24 days on single agent perifosine may have the opportunity to 1) continue on single agent perifosine; 2) switch to the combination of capecitabine + perifosine; or 3) switch to the combination of sorafenib + perifosine.
Read the detailed description
Exclusion Criteria:
- Patients with prior exposure to perifosine.
- Patients receiving any other chemotherapy, targeted agents, investigational agents or devices within four weeks (28 days) or 5 half-lives of the agent(s), whichever is longer, prior to Day1 of study treatment.
- Patients must have finished radiotherapy 28 days prior to start of treatment. Radiotherapy is not permitted in the Treatment Phase. Palliative radiotherapy to single sites for symptom control is allowed only during the Continuation Phase. The clinical coordinator should be contacted prior to initiating radiotherapy in this setting.
- Patients who have had a major surgical procedure, open biopsy, or significant traumatic injury ≤4 weeks prior to Day 1 of study treatment.
- Patients with a serious non-healing wound, active ulcer, or untreated bone fracture.
- Patients with known central nervous system (CNS) metastases. Patients with CNS metastases that have been treated and are stable and who do not require corticosteroid treatment for the metastases (off steroids > 4 weeks) will be allowed.
- Serious active infection requiring parenteral antibiotics or antifungal therapy.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to perifosine (miltefosine or edelfosine).
- Patients with known dipyrimidine dehydrogenase (DPD) deficiency or prior severe reaction to 5-FU (for patients electing to receive capecitabine therapy in the Continuation Phase).
- Patients with known HIV or acute or chronic active Hepatitis B or Hepatitis C.
- Uncontrolled inter-current illness including, but not limited to, ongoing or active infection and psychiatric illness/social situations that would Limit compliance with study requirements.
- Patients with a history of unstable or newly diagnosed angina pectoris, recent myocardial infarction (within 6 months of enrollment), or New York Heart Association class II-IV congestive heart failure (Appendix B).
- Female patients who are pregnant or lactating. All females of childbearing potential must have a negative serum pregnancy test within 72 hours of treatment. Women of childbearing potential and men with partners of child-bearing potential, must agree to employ adequate contraception to prevent pregnancy while on therapy and for 4 weeks after the completion of treatment (see Appendix C).
- A history of additional risk factors for Torsades de Pointes (e.g. familial long QT syndrome, hypokalemia, heart failure (Appendix B), left ventricular hypertrophy, slow heart rate (<45 bpm)).
- Required use of concomitant medications known to prolong the QT/QTc interval
- Conditions
- Cancer
- Being tested
- perifosine
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
perifosineDrug
Also called D-21266, KRX-0401
100 mg daily
| Study group | Role | What they receive |
|---|---|---|
| Perifosine 100 mg | Experimental | Perifosine 100 mg orally daily under Fed and Fasted conditions Receives: Drug: perifosine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the effects of food on the PK profile and bioavailability of perifosine, and to evaluate the effects of perifosine treatment on ECG parameters
- To assess the Pharmacokinetic profile of perifosine when given to patients under fed and fasted conditions
- To evaluate changes in other ECG parameters associated with perifosine treatment (ventricular rate, PR interval, QRS interval, QT interval)
Measured: 24 days
Secondary outcomes (1)
To evaluate the safety and efficacy of perifosine when given to patients with advanced malignancies
- To evaluate the safety profile (adverse events) and efficacy (response rate, and time to progression) of all study patients treated with perifosine.
- After Day 24, to evaluate the safety profile (adverse events) and efficacy (response rate and time to progression) of all study patients who remain on single agent perifosine, switch to the combination of capecitabine + perifosine or switch to the combination of sorafenib + perifosine.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2010 (estimated)
- Study start24 Jan 2012
- Primary completion4 Nov 2013
- Study completion4 Nov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- AEterna Zentaris
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ed Cullen, PhD, Study director, Keryx / AOI Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01224730
- Sponsor's protocol ID
- Protocol 147
- Status last verified
- May 2012
- First submitted
- 19 Oct 2010
- Last updated
- 14 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Food Effect and QTc Study of Perifosine in Patients With Advanced Malignancies
- ClinicalTrials.gov ID
- NCT01224730
- Acronym / sponsor ID
- Protocol 147
- Conditions
- Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- AEterna ZentarisIndustry (pharma, biotech, devices)
- Study start
- 24 Jan 2012 (actual)
- Primary completion
- 4 Nov 2013 (actual)
- Study completion
- 4 Nov 2013 (actual)
- First posted
- 20 Oct 2010 (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.
This is a Phase I study which will analyze any food-drug effects as well as QTc effects of perifosine. Safety and efficacy will also be evaluated.
Patients who complete the first 24 days on single agent perifosine may have the opportunity to 1) continue on single agent perifosine; 2) switch to the combination of capecitabine + perifosine; or 3) switch to the combination of sorafenib + perifosine.
Detailed description
Exclusion Criteria:
- Patients with prior exposure to perifosine.
- Patients receiving any other chemotherapy, targeted agents, investigational agents or devices within four weeks (28 days) or 5 half-lives of the agent(s), whichever is longer, prior to Day1 of study treatment.
- Patients must have finished radiotherapy 28 days prior to start of treatment. Radiotherapy is not permitted in the Treatment Phase. Palliative radiotherapy to single sites for symptom control is allowed only during the Continuation Phase. The clinical coordinator should be contacted prior to initiating radiotherapy in this setting.
- Patients who have had a major surgical procedure, open biopsy, or significant traumatic injury ≤4 weeks prior to Day 1 of study treatment.
- Patients with a serious non-healing wound, active ulcer, or untreated bone fracture.
- Patients with known central nervous system (CNS) metastases. Patients with CNS metastases that have been treated and are stable and who do not require corticosteroid treatment for the metastases (off steroids > 4 weeks) will be allowed.
- Serious active infection requiring parenteral antibiotics or antifungal therapy.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to perifosine (miltefosine or edelfosine).
- Patients with known dipyrimidine dehydrogenase (DPD) deficiency or prior severe reaction to 5-FU (for patients electing to receive capecitabine therapy in the Continuation Phase).
- Patients with known HIV or acute or chronic active Hepatitis B or Hepatitis C.
- Uncontrolled inter-current illness including, but not limited to, ongoing or active infection and psychiatric illness/social situations that would Limit compliance with study requirements.
- Patients with a history of unstable or newly diagnosed angina pectoris, recent myocardial infarction (within 6 months of enrollment), or New York Heart Association class II-IV congestive heart failure (Appendix B).
- Female patients who are pregnant or lactating. All females of childbearing potential must have a negative serum pregnancy test within 72 hours of treatment. Women of childbearing potential and men with partners of child-bearing potential, must agree to employ adequate contraception to prevent pregnancy while on therapy and for 4 weeks after the completion of treatment (see Appendix C).
- A history of additional risk factors for Torsades de Pointes (e.g. familial long QT syndrome, hypokalemia, heart failure (Appendix B), left ventricular hypertrophy, slow heart rate (<45 bpm)).
- Required use of concomitant medications known to prolong the QT/QTc interval
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Perifosine 100 mg | Experimental | Drug: perifosinePerifosine 100 mg orally daily under Fed and Fasted conditions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with advanced malignancies
- Patients with adequate organ and marrow function
Key exclusion criteria (2 listed)
- Patients previously treated with perifosine
- Patients receiving any other chemotherapy, targeted agents, investigational agents or devices within four weeks (28 days) prior to Day 1 of study treatment
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 |
|---|---|---|
| perifosineAlso: D-21266, KRX-0401100 mg daily | Drug | Perifosine 100 mg |
Primary outcome
To evaluate the effects of food on the PK profile and bioavailability of perifosine, and to evaluate the effects of perifosine treatment on ECG parameters
Time frame: 24 days
* To assess the Pharmacokinetic profile of perifosine when given to patients under fed and fasted conditions * To evaluate changes in other ECG parameters associated with perifosine treatment (ventricular rate, PR interval, QRS interval, QT interval)
1 secondary outcome
To evaluate the safety and efficacy of perifosine when given to patients with advanced malignancies
Time frame: Up to 6 months
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 14 Mar 2018.
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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.
Ed Cullen, PhD study director
Keryx / AOI Pharmaceuticals, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing perifosine in people with Cancer, run by AEterna Zentaris at 2 sites in United States.
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 2 inclusion and 2 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 14 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
To evaluate the effects of food on the PK profile and bioavailability of perifosine, and to evaluate the effects of perifosine treatment on ECG parameters (time frame: 24 days). 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 14 Mar 2018.