NeoplasmsPhase 1NCT00398697
Phase I Perifosine and Gemcitabine Study
A Phase 1 study testing Perifosine and Gemcitabine in people with Neoplasms, run by AEterna Zentaris at 1 site in United States.
Trial summary
This is a study of the drug perifosine in combination with Gemcitabine. Perifosine is an oral anti-cancer agent that has been used in more than 140 people, but has not been combined with other drugs before this study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- Perifosine and Gemcitabine
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2004to Jan 2006
- 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 must have histologically or cytologically confirmed diagnosis of cancer for which treatment with single agent gemcitabine would be an appropriate treatment option
- At least 18 years of age
- Patients may have received no more than two prior chemotherapy regimens
- Patients must have a life expectancy of more than 3 months.
- Patients must have a performance status of 0 to 2 according to the ECOG criteria
- Patients must have normal organ and marrow function as defined in the protocol.
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- Patients must have recovered from any acute toxicity related to prior therapy, including surgery or radiotherapy.
- Patients must be able to ingest oral medications.
- Female patients who are pregnant or lactating are ineligible. All females of childbearing potential must have a negative serum pregnancy test within 72 hours of treatment. Men and women of childbearing potential must agree to employ adequate contraception.
- Patients must have ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Patients may not be receiving any other investigational agents or devices.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to perifosine (miltefosine or edelfosine).
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection and psychiatric illness/social situations that would limit compliance with study requirements.
- HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with perifosine. HIV-positive patients not receiving combination anti-retroviral therapy must be approved by the study chair prior to entry.
- Patients with a history of unstable or newly diagnosed angina pectoris, recent myocardial infarction (within 6 months of enrollment) or New York Heart Assoc. class II-IV congestive heart failure.
- Radiation therapy to > 50% of marrow producing sites.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1 Trial of the Combination of Perifosine and Gemcitabine
This is a study of the drug perifosine in combination with Gemcitabine. Perifosine is an oral anti-cancer agent that has been used in more than 140 people, but has not been combined with other drugs before this study. The study is designed to determine the highest dose of perifosine that can be administered to people every day while they are on a Gemcitabine regimen, without severe or prolonged nausea, vomiting and diarrhea. This study starts with patients taking 50 mg/day and goes up to 150 mg/day. After the highest tolerable dose is found, we will add 10 more patients at that dose.
Read the detailed description
This is a phase 1, open-label trial of perifosine and gemcitabine in patients with malignancies for whom single agent gemcitabine is a reasonable treatment option. All patients will receive gemcitabine at a dose of 1000 mg/m2 on days 1 and 8 of a 21-day cycle. Patients will receive perifosine orally at a dose of 50, 100 or 150 mg per day for the first 14 days of the 21-day cycle. Cohorts of 3 patients will be treated with doses of 50 mg administered either once, twice or three times a day. In this study a maximum tolerated dose (MTD) will be defined as a dose that can be given without grade 3/4 non-hematologic toxicity in more than 1/3 patients. If 2/3 patients in any cohort encounter a grade 3/4 non-hematologic toxicity, an additional 3 patients will be added. If the dose is intolerable for >3/6 patients then the previous level will be declared the MTD. Once an MTD has been determined an additional 10 patients will be added at the MTD to better define the expected toxicities.
- Conditions
- Neoplasms
- Being tested
- Perifosine, Gemcitabine
- Keywords
- perifosine, gemcitabine
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PerifosineDrug
GemcitabineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
GI Toxicities
Secondary outcomes (2)
Other toxicities
Disease progression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2006 (estimated)
- Study startAug 2004
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NeoplasmsStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants
Sponsor and investigators
- Lead sponsor
- AEterna Zentaris
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Robert Birch, Ph.D., Study director, Keryx / AOI Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00398697
- Sponsor's protocol ID
- Perifosine 102
- Status last verified
- Jan 2007
- First submitted
- 10 Nov 2006
- Last updated
- 13 Feb 2014
- Results posted
- No
Publications
Journal of Clinical Oncology, 2006 ASCO Annual Meeting Proceedings (Post-Meeting Edition). Vol 24, No 18S (June 20 Supplement), 2006: 13084
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Trial of the Combination of Perifosine and Gemcitabine
- ClinicalTrials.gov ID
- NCT00398697
- Acronym / sponsor ID
- Perifosine 102
- Conditions
- Neoplasms
- Keywords
- perifosine, gemcitabine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants
- Lead sponsor
- AEterna ZentarisIndustry (pharma, biotech, devices)
- Study start
- Aug 2004
- Study completion
- Jan 2006
- First posted
- 14 Nov 2006 (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 study of the drug perifosine in combination with Gemcitabine. Perifosine is an oral anti-cancer agent that has been used in more than 140 people, but has not been combined with other drugs before this study. The study is designed to determine the highest dose of perifosine that can be administered to people every day while they are on a Gemcitabine regimen, without severe or prolonged nausea, vomiting and diarrhea. This study starts with patients taking 50 mg/day and goes up to 150 mg/day. After the highest tolerable dose is found, we will add 10 more patients at that dose.
Detailed description
This is a phase 1, open-label trial of perifosine and gemcitabine in patients with malignancies for whom single agent gemcitabine is a reasonable treatment option. All patients will receive gemcitabine at a dose of 1000 mg/m2 on days 1 and 8 of a 21-day cycle. Patients will receive perifosine orally at a dose of 50, 100 or 150 mg per day for the first 14 days of the 21-day cycle. Cohorts of 3 patients will be treated with doses of 50 mg administered either once, twice or three times a day. In this study a maximum tolerated dose (MTD) will be defined as a dose that can be given without grade 3/4 non-hematologic toxicity in more than 1/3 patients. If 2/3 patients in any cohort encounter a grade 3/4 non-hematologic toxicity, an additional 3 patients will be added. If the dose is intolerable for >3/6 patients then the previous level will be declared the MTD. Once an MTD has been determined an additional 10 patients will be added at the MTD to better define the expected toxicities.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients must have histologically or cytologically confirmed diagnosis of cancer for which treatment with single agent gemcitabine would be an appropriate treatment option
- At least 18 years of age
- Patients may have received no more than two prior chemotherapy regimens
- Patients must have a life expectancy of more than 3 months.
- Patients must have a performance status of 0 to 2 according to the ECOG criteria
Key exclusion criteria (6 listed)
- Patients may not be receiving any other investigational agents or devices.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to perifosine (miltefosine or edelfosine).
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection and psychiatric illness/social situations that would limit compliance with study requirements.
- HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with perifosine. HIV-positive patients not receiving combination anti-retroviral therapy must be approved by the study chair prior to entry.
- Patients with a history of unstable or newly diagnosed angina pectoris, recent myocardial infarction (within 6 months of enrollment) or New York Heart Assoc. class II-IV congestive heart failure.
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 |
|---|---|---|
| Perifosine | Drug | – |
| Gemcitabine | Drug | – |
Primary outcome
GI Toxicities
2 secondary outcomes
Other toxicities
Disease progression
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 13 Feb 2014.
- Results publicationJournal of Clinical Oncology, 2006 ASCO Annual Meeting Proceedings (Post-Meeting Edition). Vol 24, No 18S (June 20 Supplement), 2006: 13084
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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.
Robert Birch, Ph.D. study director
Keryx / AOI Pharmaceuticals, Inc.
1 site 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 and Gemcitabine in people with Neoplasms, run by AEterna Zentaris at 1 site 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 10 inclusion and 6 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 13 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
GI Toxicities. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00398697, which also lists 1 linked publication.
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 13 Feb 2014; AzTrials last refreshed its copy on 5 Nov 2026.