Kidney CancerPhase 2NCT00498966
Ph II Study of Perifosine for Patients With Carcinoma of the Kidney
A Phase 2 study testing Perifosine in people with Kidney Cancer, run by AEterna Zentaris at 3 sites in United States.
Trial summary
This is a Phase II study. Patients with kidney carcinoma will be considered in two groups. The goals of this study are: To measure clinical benefit defined as tumor response or progression-free survival for more than 12 weeks in patients with metastatic carcinoma of the kidney who have failed or have progressed on a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney 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
- 50 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2007to Oct 2011
- 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
- Patients with confirmed metastatic RCC
- Patients must have documented progression on treatment with sunitinib or sorafenib. Prior therapy with bevacizumab and/or cytokines (i.e., IL-2, interferon) is permitted. Prior vaccine therapy in the adjuvant setting is also permitted. Patients can have failed therapy with ONE prior mTOR inhibitor.
- Patients must have at least one measurable lesion on computer tomography (CT) Scan or magnetic resonance imaging (MRI) using Modified RECIST criteria.
- Patients must have normal organ and marrow function, unless in the opinion of the treating investigator, the abnormality is related to tumor, and the study chairman agree the abnormality is unlikely to affect the safety of perifosine use. Normal organ and marrow function is described below:
- ANC >= 1.5 x 109/L
- Platelets >= 75,000/ mm3
Show all 16Show fewer
- HCT >= 28% (with or without growth factor support)
- Creatinine <= 3.0 mg/dl
- Total bilirubin <= 1.5 x upper limit of normal
- Transaminase <= 2.5 x upper limit of normal
- ECOG performance status of 0 or 1
- Patients with CNS metastases must be clinically stable for at least 2 months following treatment with radiation therapy, surgery, or both; and be off corticosteroids and anti-seizure medication.
- Patients with a life expectancy ≥6 months
- Age ≥18 years old
- Patients who give a written informed consent obtained according to local guidelines
- Women of childbearing potential must have had a negative serum or urine pregnancy test 72 hours prior to the administration of the first study treatment.
Who cannot join
- Patients who have not recovered (<= grade 1) from adverse events from prior therapy (excluding alopecia).
- Patients currently receiving sorafenib or sunitinib who have received either of these within 2 weeks prior to study entry.
- Patients may have had prior sorafenib OR sunitinib BUT cannot have been treated with both VEGF receptor inhibitors.
- Patients with a known hypersensitivity to perifosine or its excipients.
- Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods.
- Patients who are using other investigational agents or who had received investigational drugs <= 4 weeks prior to study entry.
- Patients unwilling to or unable to comply with the protocol.
- Patients who have a history of another primary malignancy <= 5 years with the exceptions of non melanomatous skin cancer and carcinoma in situ of the cervix.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Investigative Site
Armonk, New York, 10504
Investigative Site
Louisville, Kentucky, 40202
Investigative Site
Morristown, New Jersey, 07962
About this study
Official title: Phase II Study of Perifosine for Patients With Metastatic Carcinoma of the Kidney Who Have Progressed on a VEGF Receptor Inhibitor
This is a Phase II study. Patients with kidney carcinoma will be considered in two groups. The goals of this study are:
- To measure clinical benefit defined as tumor response or progression-free survival for more than 12 weeks in patients with metastatic carcinoma of the kidney who have failed or have progressed on a VEGF receptor inhibitor
- To evaluate the safety of perifosine in patients with metastatic carcinoma of the kidney who have failed or have progressed on a VEGF receptor inhibitor
Read the detailed description
This is a Phase II study. Patients with kidney carcinoma will be considered in two groups. Patients in group A will have previously failed a VEGF receptor inhibitor but not an mTOR inhibitor, while patients in group B will have failed both a VEGF receptor inhibitor and an mTOR inhibitor. Evaluation of each group will be performed separately. The goals of this study are:
- To measure clinical benefit defined as an objective tumor response using RESIST or progression-free survival for more than 12 weeks in patients with metastatic carcinoma of the kidney who have failed or have progressed on a VEGF receptor inhibitor
- To evaluate the safety of perifosine in patients with metastatic carcinoma of the kidney who have failed or have progressed on a VEGF receptor inhibitor.
Treatment Phase/duration of treatment: All patients will be treated with daily perifosine at 100 mg PO daily until tumor progression (by the RECIST criteria) or unacceptable toxicity. Once radiological disease progression has been documented by the treating physician, the patient will go off study. Patients are encouraged to have two measurements for confirmation of progression.
Follow-Up Phase: All patients will be followed-up for SAEs until at least 30 days after discontinuation of perifosine. All patients who are discontinued from perifosine for any reason other than disease progression will continue to have tumor assessments until the patient has documented disease progression or has begun other therapies.
- Conditions
- Kidney Cancer
- Being tested
- Perifosine
- Keywords
- Kidney, perifosine, Progression on treatment with sunitinib or sorafenib
- Medical subject headings
- Kidney 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
Perifosine 100 mg PO Perifosine is supplied as a film-coated tablet containing 50 mg of active ingredient.
Treatment will be administered on an outpatient basis in 28-day cycles. The patient dose for daily administration will be 100 mg qhs daily with food.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Patients in group A will have previously failed a VEGF receptor inhibitor but not an mTOR inhibitor.Intervention: Perifosine. Receives: Drug: Perifosine |
| Group B | Experimental | Patients in group B will have failed both a VEGF receptor inhibitor and an mTOR inhibitor. Intervention: Perifosine. Receives: Drug: Perifosine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective tumor response using RESIST OR progression-free survival
Clinical benefit, defined as either an objective response by RECIST or PFS >12 weeks, is a primary endpoint of the study. The clinical benefit rate together with its two-sided exact binomial 95% confidence interval will be reported.
Measured: 12 weeks
Secondary outcomes (1)
Evaluate the safety of perifosine in patients with metastatic carcinoma of the kidney
Safety endpoints include: incidence of adverse events, serious adverse events, change in vital signs and change in laboratory results (hematology, blood chemistry, urinalysis).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2007 (estimated)
- Study startJul 2007
- Primary completionJul 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 Kidney 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Two groups with regard to pre-treatment: patients in group A will have previously failed a VEGF receptor inhibitor but not an mTOR inhibitor, while patients in group B will have failed both a VEGF receptor inhibitor and an mTOR inhibitor. One treatment group: all patients will receive perifosine 100 mg qhs daily orally. Patients are to be instructed that perifosine is to be taken with food.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- AEterna Zentaris
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nicholas J Vogelzang, MD, Study chair, Nevada Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00498966
- Sponsor's protocol ID
- Perifosine 231
- Status last verified
- Feb 2018
- First submitted
- 9 Jul 2007
- Last updated
- 5 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Journal of Clinical Oncology, 2009 ASCO Annual Meeting Proceedings (Post-Meeting Edition). Vol 27, No 15S (May 20 Supplement), 2009: 5101
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Perifosine for Patients With Metastatic Carcinoma of the Kidney Who Have Progressed on a VEGF Receptor Inhibitor
- ClinicalTrials.gov ID
- NCT00498966
- Acronym / sponsor ID
- Perifosine 231
- Conditions
- Kidney Cancer
- Keywords
- Kidney, perifosine, Progression on treatment with sunitinib or sorafenib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- AEterna ZentarisIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Jul 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 11 Jul 2007 (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 II study. Patients with kidney carcinoma will be considered in two groups. The goals of this study are:
- To measure clinical benefit defined as tumor response or progression-free survival for more than 12 weeks in patients with metastatic carcinoma of the kidney who have failed or have progressed on a VEGF receptor inhibitor
- To evaluate the safety of perifosine in patients with metastatic carcinoma of the kidney who have failed or have progressed on a VEGF receptor inhibitor
Detailed description
This is a Phase II study. Patients with kidney carcinoma will be considered in two groups. Patients in group A will have previously failed a VEGF receptor inhibitor but not an mTOR inhibitor, while patients in group B will have failed both a VEGF receptor inhibitor and an mTOR inhibitor. Evaluation of each group will be performed separately. The goals of this study are:
- To measure clinical benefit defined as an objective tumor response using RESIST or progression-free survival for more than 12 weeks in patients with metastatic carcinoma of the kidney who have failed or have progressed on a VEGF receptor inhibitor
- To evaluate the safety of perifosine in patients with metastatic carcinoma of the kidney who have failed or have progressed on a VEGF receptor inhibitor.
Treatment Phase/duration of treatment: All patients will be treated with daily perifosine at 100 mg PO daily until tumor progression (by the RECIST criteria) or unacceptable toxicity. Once radiological disease progression has been documented by the treating physician, the patient will go off study. Patients are encouraged to have two measurements for confirmation of progression.
Follow-Up Phase: All patients will be followed-up for SAEs until at least 30 days after discontinuation of perifosine. All patients who are discontinued from perifosine for any reason other than disease progression will continue to have tumor assessments until the patient has documented disease progression or has begun other therapies.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two groups with regard to pre-treatment: patients in group A will have previously failed a VEGF receptor inhibitor but not an mTOR inhibitor, while patients in group B will have failed both a VEGF receptor inhibitor and an mTOR inhibitor. One treatment group: all patients will receive perifosine 100 mg qhs daily orally. Patients are to be instructed that perifosine is to be taken with food.
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: PerifosinePatients in group A will have previously failed a VEGF receptor inhibitor but not an mTOR inhibitor.Intervention: Perifosine. |
| Group B | Experimental | Drug: PerifosinePatients in group B will have failed both a VEGF receptor inhibitor and an mTOR inhibitor. Intervention: Perifosine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Patients with confirmed metastatic RCC
- Patients must have documented progression on treatment with sunitinib or sorafenib. Prior therapy with bevacizumab and/or cytokines (i.e., IL-2, interferon) is permitted. Prior vaccine therapy in the adjuvant setting is also permitted. Patients can have failed therapy with ONE prior mTOR inhibitor.
- Patients must have at least one measurable lesion on computer tomography (CT) Scan or magnetic resonance imaging (MRI) using Modified RECIST criteria.
- Patients must have normal organ and marrow function, unless in the opinion of the treating investigator, the abnormality is related to tumor, and the study chairman agree the abnormality is unlikely to affect the safety of perifosine use. Normal organ and marrow function is described below:
- ECOG performance status of 0 or 1
Key exclusion criteria (8 listed)
- Patients who have not recovered (<= grade 1) from adverse events from prior therapy (excluding alopecia).
- Patients currently receiving sorafenib or sunitinib who have received either of these within 2 weeks prior to study entry.
- Patients may have had prior sorafenib OR sunitinib BUT cannot have been treated with both VEGF receptor inhibitors.
- Patients with a known hypersensitivity to perifosine or its excipients.
- Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods.
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-0401Perifosine 100 mg PO Perifosine is supplied as a film-coated tablet containing 50 mg of active ingredient. Treatment will be administered on an outpatient basis in 28-day cycles. The patient dose for daily administration will be 100 mg qhs daily with food. | Drug | Group A, Group B |
Primary outcome
Objective tumor response using RESIST OR progression-free survival
Time frame: 12 weeks
Clinical benefit, defined as either an objective response by RECIST or PFS >12 weeks, is a primary endpoint of the study. The clinical benefit rate together with its two-sided exact binomial 95% confidence interval will be reported.
1 secondary outcome
Evaluate the safety of perifosine in patients with metastatic carcinoma of the kidney
Time frame: 12 weeks
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 5 Feb 2018.
- Results publicationJournal of Clinical Oncology, 2009 ASCO Annual Meeting Proceedings (Post-Meeting Edition). Vol 27, No 15S (May 20 Supplement), 2009: 5101
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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.
Nicholas J Vogelzang, MD study chair
Nevada Cancer Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Perifosine in people with Kidney Cancer, run by AEterna Zentaris at 3 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 16 inclusion and 8 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 5 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 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?
Objective tumor response using RESIST OR progression-free survival (time frame: 12 weeks). 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 NCT00498966, 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 5 Feb 2018.