Renal CancerPhase 1NCT00398814
Phase I Study of Perifosine + Sorafenib for Patients With Advanced Cancers
A Phase 1 study testing Perifosine and Sorafenib in people with Renal Cancer and Tumors, run by AEterna Zentaris.
Trial summary
This study is a Phase I trial in two parts. In part 1, a MTD to the combination of perifosine and sorafenib will be determined. In part 2, with the MTD as a starting point, a group of patients will be accrued with the goal of ensuring that they will be able to tolerate at least three courses of therapy, which would… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cancer, Tumors
- What is being tested?
- Perifosine and Sorafenib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Oct 2006to Oct 2011
- 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 a histologically or cytologically confirmed diagnosis of renal or hepatocellular tumor are eligible for this protocol. Patients with other solid tumor types must have their cases reviewed by the medical monitor.
- The physician must believe that the patient's course and the growth rate of the tumor are such that the patient would feel comfortable continuing treatment for 12 weeks even if there is a transient period of modest tumor growth during the first weeks following the initiation of perifosine and sorafenib treatment.
- Patients must have a life expectancy of more than 6 months.
- Patients may have received prior sorafenib or sunitinib malate.
- Patients may have measurable or evaluable disease.
- Patients should have a performance status of 0 to 1 according to the ECOG criteria.
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- Patients must have adequate organ and marrow function, unless in the opinion of the treating investigator, the abnormality is related to tumor and the medical monitor agrees the abnormality is unlikely to affect the safety of perifosine use.
- Patients must have recovered from acute toxicity related to prior therapy including surgery or radiotherapy, excluding alopecia.
- Patients with breast cancer or prostate cancer who discontinue endocrine therapy prior to entry onto this study must wait for a minimum of 1 month and then be reassessed for a withdrawal response prior to starting perifosine. However, it is not a requirement that endocrine therapies be discontinued.
- Patients must be able to ingest oral medications or to obtain them through a gastrostomy tube.
- Patients must be at least 18 years of age.
- Patients must have ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Rapidly progressing disease, as defined by progression within 12 weeks of initiation of the previous regimen (see Section 8.2.8 below)
- Patients who have had more than three prior systemic therapies, including biologics, are excluded unless prior approval is obtained from the medical monitor.
- Patients receiving any other investigational agents or devices
- Patients initiating treatment for their cancer within the last two months who will be continued concomitantly with perifosine
- 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
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- HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with perifosine.
- 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
- Female patients who are pregnant or lactating are ineligible.
About this study
Official title: An Open-Label Phase I Study of the Safety of Perifosine in Combination With Sorafenib for Patients With Advanced Cancers
This study is a Phase I trial in two parts. In part 1, a MTD to the combination of perifosine and sorafenib will be determined. In part 2, with the MTD as a starting point, a group of patients will be accrued with the goal of ensuring that they will be able to tolerate at least three courses of therapy, which would make them evaluable for response in a Phase II study.
Read the detailed description
This study is a Phase I trial in two parts. In part 1, an MTD to the combination of perifosine and sorafenib will be determined. The experience with perifosine and other biologic agents has been that doses determined in Phase I studies are not as well tolerated in larger groups of patients when response is an endpoint. Thus in part 2, with the MTD as a starting point, a group of patients will be accrued with the goal of ensuring that they will be able to tolerate at least three courses of therapy, which would make them evaluable for response in a Phase II study. The effects of the combination of perifosine and sorafenib will be evaluated for response rate and time to progression. The pharmacokinetics of the combination of the study drugs will be measured.
For the purposes of this study, one cycle of therapy will be defined as 4 weeks. Patients will take perifosine one to three times a day and will also receive sorafenib one to two times a day. Patients may need anti-emetics and/or anti-diarrheals.
- Patients who experience toxicity may continue on treatment with doses delayed or reduced.
- All patients should continue therapy unless disease progression is documented on two occasions four weeks apart
All patients should be evaluated at each visit for adverse events. Patients will keep a diary documenting compliance with study drug, toxicities and any symptoms of hand/foot syndrome including numbness, tingling, redness or presence of sores, and any symptoms of hypertension. Patients will be evaluated for progression or response at 12-week intervals.
- Conditions
- Renal Cancer, Tumors
- Being tested
- Perifosine, Sorafenib
- Keywords
- Perifosine, Sorafenib, Renal cancer, Hepatocellular cancer, other advanced solid tumors
- Medical subject headings
- Kidney Neoplasms, Neoplasms, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PerifosineDrug
For the purposes of this study, one cycle of therapy will be defined as 4 weeks. Patients will take perifosine one to three times a day and will also receive sorafenib one to two times a day.
SorafenibDrug
For the purposes of this study, one cycle of therapy will be defined as 4 weeks. Patients will take perifosine one to three times a day and will also receive sorafenib one to two times a day.
| Study group | Role | What they receive |
|---|---|---|
| Perifosine + Sorafenib | Experimental | Not described Receives: Drug: Perifosine; Drug: Sorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicity
Measured: Monthly
Secondary outcomes (1)
Response or progression
Measured: 6 months
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 startOct 2006
- Primary completionSep 2011
- Study completionOct 2011
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 Renal 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- AEterna Zentaris
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00398814
- Sponsor's protocol ID
- Perifosine 124
- Status last verified
- Nov 2011
- First submitted
- 9 Nov 2006
- Last updated
- 19 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Preliminary results / Journal of Clinical Oncology, 2008 ASCO Annual Meeting Proceedings (Post-Meeting Edition). Vol 26, No 15S (May 20 Supplement), 2008: 16024
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Phase I Study of the Safety of Perifosine in Combination With Sorafenib for Patients With Advanced Cancers
- ClinicalTrials.gov ID
- NCT00398814
- Acronym / sponsor ID
- Perifosine 124
- Conditions
- Renal Cancer, Tumors
- Keywords
- Perifosine, Sorafenib, Renal cancer, Hepatocellular cancer, other advanced solid tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- AEterna ZentarisIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- Primary completion
- Sep 2011 (actual)
- Study completion
- Oct 2011 (actual)
- 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 study is a Phase I trial in two parts. In part 1, a MTD to the combination of perifosine and sorafenib will be determined. In part 2, with the MTD as a starting point, a group of patients will be accrued with the goal of ensuring that they will be able to tolerate at least three courses of therapy, which would make them evaluable for response in a Phase II study.
Detailed description
This study is a Phase I trial in two parts. In part 1, an MTD to the combination of perifosine and sorafenib will be determined. The experience with perifosine and other biologic agents has been that doses determined in Phase I studies are not as well tolerated in larger groups of patients when response is an endpoint. Thus in part 2, with the MTD as a starting point, a group of patients will be accrued with the goal of ensuring that they will be able to tolerate at least three courses of therapy, which would make them evaluable for response in a Phase II study. The effects of the combination of perifosine and sorafenib will be evaluated for response rate and time to progression. The pharmacokinetics of the combination of the study drugs will be measured.
For the purposes of this study, one cycle of therapy will be defined as 4 weeks. Patients will take perifosine one to three times a day and will also receive sorafenib one to two times a day. Patients may need anti-emetics and/or anti-diarrheals.
- Patients who experience toxicity may continue on treatment with doses delayed or reduced.
- All patients should continue therapy unless disease progression is documented on two occasions four weeks apart
All patients should be evaluated at each visit for adverse events. Patients will keep a diary documenting compliance with study drug, toxicities and any symptoms of hand/foot syndrome including numbness, tingling, redness or presence of sores, and any symptoms of hypertension. Patients will be evaluated for progression or response at 12-week intervals.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Perifosine + Sorafenib | Experimental | Drug: Perifosine, Drug: Sorafenib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients with a histologically or cytologically confirmed diagnosis of renal or hepatocellular tumor are eligible for this protocol. Patients with other solid tumor types must have their cases reviewed by the medical monitor.
- The physician must believe that the patient's course and the growth rate of the tumor are such that the patient would feel comfortable continuing treatment for 12 weeks even if there is a transient period of modest tumor growth during the first weeks following the initiation of perifosine and sorafenib treatment.
- Patients must have a life expectancy of more than 6 months.
- Patients may have received prior sorafenib or sunitinib malate.
- Patients may have measurable or evaluable disease.
Key exclusion criteria (9 listed)
- Rapidly progressing disease, as defined by progression within 12 weeks of initiation of the previous regimen (see Section 8.2.8 below)
- Patients who have had more than three prior systemic therapies, including biologics, are excluded unless prior approval is obtained from the medical monitor.
- Patients receiving any other investigational agents or devices
- Patients initiating treatment for their cancer within the last two months who will be continued concomitantly with perifosine
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to perifosine (miltefosine or edelfosine)
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 |
|---|---|---|
| PerifosineFor the purposes of this study, one cycle of therapy will be defined as 4 weeks. Patients will take perifosine one to three times a day and will also receive sorafenib one to two times a day. | Drug | Perifosine + Sorafenib |
| SorafenibFor the purposes of this study, one cycle of therapy will be defined as 4 weeks. Patients will take perifosine one to three times a day and will also receive sorafenib one to two times a day. | Drug | Perifosine + Sorafenib |
Primary outcome
Toxicity
Time frame: Monthly
1 secondary outcome
Response or progression
Time frame: 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 19 Feb 2014.
- Results publicationPreliminary results / Journal of Clinical Oncology, 2008 ASCO Annual Meeting Proceedings (Post-Meeting Edition). Vol 26, No 15S (May 20 Supplement), 2008: 16024
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Perifosine and Sorafenib in people with Renal Cancer and Tumors, run by AEterna Zentaris.
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 12 inclusion and 9 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 19 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Toxicity (time frame: Monthly). 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 NCT00398814, 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 19 Feb 2014.