Renal Cell CarcinomaPhase 2NCT00448721
A Phase II Trial of Perifosine Following Tyrosine Kinase Inhibitor (TKI) - Failure in Patients With Renal Cancer
A Phase 2 study testing Perifosine in people with Renal Cell Carcinoma, run by AEterna Zentaris at 4 sites in United States.
Trial summary
This is a single-arm phase II trial of perifosine in renal cancer patients who have experienced disease progression after receiving either sorafenib or sunitinib. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma
- 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
- 4 sitesUnited States
- Study dates
- Mar 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 will be required to have clear cell renal cell carcinoma with less than 50% of any other histology (papillary or chromophobe or oncocytic). There must be histologic confirmation by the treating center of either the primary or a metastatic lesion
- Patients must have experienced disease progression by RECIST criteria while on sorafenib or sunitinib
- Patients must be off of sorafenib or sunitinib for >= 2 weeks prior to initiation of perifosine and <= 3 months prior to enrollment
- Patients may have had sorafenib or sunitinib in the adjuvant setting as long as they have experienced disease recurrence while on therapy
- Patients must have measurable disease that is not curable by standard radiation therapy or surgery
- Age >= 18 years
- ECOG performance status 0 or 1
- - Patients must have the ability to understand and willingness to sign a written informed consent document
Who cannot join
- History or clinical evidence of CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastasis, or history of stroke
- Other than sorafenib or sunitinib, patients may have only had prior immunotherapy for stage IV disease
- Patients may have had prior sorafenib OR sunitinib and cannot have been treated with both TKIs
- Patients who have stopped sorafenib or sunitinib due to toxicity but have only progressed off therapy will not be allowed
- Patients may have had prior anti-angiogenic such as bevacizumab only if given in combination with either sorafenib or sunitinib
- Prior Thalidomide or IFNα are allowed for adjuvant therapy or stage IV disease
- Patients may not have had prior mTOR inhibitors (CCI-779, RAD001)
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Investigative Site
Duarte, California, 91010
Investigative Site
Nashville, Tennessee, 37232
Investigative Site
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Phase II Trial of Perifosine Following Tyrosine Kinase Inhibitor Failure in Patients With Advanced Renal Cell Carcinoma
This is a single-arm phase II trial of perifosine in renal cancer patients who have experienced disease progression after receiving either sorafenib or sunitinib.
Read the detailed description
This is a single-arm phase II trial assessing the antitumor activity as measured by progression free survival of perifosine in patients with metastatic RCC who have progressed on sorafenib or sunitinib. A total of 48 patients will be enrolled in the trial. All subjects will have histologically confirmed metastatic RCC with predominantly clear cell features (≤ 50% other histologic features). Patients who have been taken off sorafenib or sunitinib may only have been off therapy for less than three months prior to study enrollment. Patients who remain on sorafenib or sunitinib may continue on drug at their current dose until two weeks prior to the initiation of perifosine therapy.
The study consists of three periods: pre-treatment/screening, treatment, and follow-up. Day 1 will be defined as the first day of perifosine therapy. Patients will remain in the treatment phase until progression or toxicity. Patients will be seen by an MD every 3 weeks with 6 weeks defining one cycle of therapy. Tumor evaluations will occur every 6 weeks.
- Conditions
- Renal Cell Carcinoma
- Being tested
- Perifosine
- Keywords
- renal cell carcinoma, tyrosine kinase inhibitor failure
- Medical subject headings
- Carcinoma, Renal Cell
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 will be administered orally at 100mg PO daily with food.
| Study group | Role | What they receive |
|---|---|---|
| Perifosine | Experimental | Perifosine will be administered orally at 100mg PO daily with food. One treatment cycle will consist of 42 days (6 weeks). Receives: Drug: Perifosine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To estimate the progression free survival
To estimate the progression free survival of Multi-Targeted Kinase Inhibitor (TKI) resistant patients with metastatic Renal Cell Carcinoma (RCC) who are treated with perifosine
Measured: Every 6 weeks
Secondary outcomes (5)
To determine the objective response rate of perifosine
To determine the objective response rate of TKI resistant patients with metastatic RCC treated with perifosine.
Measured: Every 6 weeks
To investigate the tolerability and toxicity
To investigate the tolerability and toxicity of perifosine in TKI resistant patients
Measured: Every 6 weeks
To investigate surrogates of biologic target inhibition
To investigate surrogates of biologic target inhibition on PBMC's before and after therapy.
Measured: Every 6 weeks
To collect pre-treatment tissue specimens
To collect pre-treatment tissue specimens and assess the pre-treatment activation status of the MAP-Kinase and PI3K-Akt pathways and correlate with clinical outcome.
Measured: Every 6 weeks
To follow levels of pro-angiogenic cytokines
To follow levels of pro-angiogenic cytokines and surrogates of HIF activation before and during therapy.
Measured: Every 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2007 (estimated)
- Study startMar 2007
- Primary completionOct 2010
- 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 Cell CarcinomaStudies 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
- 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)
- Collaborators
- Dana-Farber Cancer Institute
- Responsible party
- Sponsor
- Investigators
- Daniel Cho, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00448721
- Sponsor's protocol ID
- Perifosine 228
- Status last verified
- Feb 2012
- First submitted
- 15 Mar 2007
- Last updated
- 1 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
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 1 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Perifosine Following Tyrosine Kinase Inhibitor Failure in Patients With Advanced Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT00448721
- Acronym / sponsor ID
- Perifosine 228
- Conditions
- Renal Cell Carcinoma
- Keywords
- renal cell carcinoma, tyrosine kinase inhibitor failure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- AEterna ZentarisIndustry (pharma, biotech, devices)
- Collaborators
- Dana-Farber Cancer Institute
- Study start
- Mar 2007
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 19 Mar 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 single-arm phase II trial of perifosine in renal cancer patients who have experienced disease progression after receiving either sorafenib or sunitinib.
Detailed description
This is a single-arm phase II trial assessing the antitumor activity as measured by progression free survival of perifosine in patients with metastatic RCC who have progressed on sorafenib or sunitinib. A total of 48 patients will be enrolled in the trial. All subjects will have histologically confirmed metastatic RCC with predominantly clear cell features (≤ 50% other histologic features). Patients who have been taken off sorafenib or sunitinib may only have been off therapy for less than three months prior to study enrollment. Patients who remain on sorafenib or sunitinib may continue on drug at their current dose until two weeks prior to the initiation of perifosine therapy.
The study consists of three periods: pre-treatment/screening, treatment, and follow-up. Day 1 will be defined as the first day of perifosine therapy. Patients will remain in the treatment phase until progression or toxicity. Patients will be seen by an MD every 3 weeks with 6 weeks defining one cycle of therapy. Tumor evaluations will occur every 6 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Perifosine | Experimental | Drug: PerifosinePerifosine will be administered orally at 100mg PO daily with food. One treatment cycle will consist of 42 days (6 weeks). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients will be required to have clear cell renal cell carcinoma with less than 50% of any other histology (papillary or chromophobe or oncocytic). There must be histologic confirmation by the treating center of either the primary or a metastatic lesion
- Patients must have experienced disease progression by RECIST criteria while on sorafenib or sunitinib
- Patients must be off of sorafenib or sunitinib for >= 2 weeks prior to initiation of perifosine and <= 3 months prior to enrollment
- Patients may have had sorafenib or sunitinib in the adjuvant setting as long as they have experienced disease recurrence while on therapy
- Patients must have measurable disease that is not curable by standard radiation therapy or surgery
Key exclusion criteria (7 listed)
- History or clinical evidence of CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastasis, or history of stroke
- Other than sorafenib or sunitinib, patients may have only had prior immunotherapy for stage IV disease
- Patients may have had prior sorafenib OR sunitinib and cannot have been treated with both TKIs
- Patients who have stopped sorafenib or sunitinib due to toxicity but have only progressed off therapy will not be allowed
- Patients may have had prior anti-angiogenic such as bevacizumab only if given in combination with either sorafenib or sunitinib
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 will be administered orally at 100mg PO daily with food. | Drug | Perifosine |
Primary outcome
To estimate the progression free survival
Time frame: Every 6 weeks
To estimate the progression free survival of Multi-Targeted Kinase Inhibitor (TKI) resistant patients with metastatic Renal Cell Carcinoma (RCC) who are treated with perifosine
5 secondary outcomes
To determine the objective response rate of perifosine
Time frame: Every 6 weeks
To investigate the tolerability and toxicity
Time frame: Every 6 weeks
To investigate surrogates of biologic target inhibition
Time frame: Every 6 weeks
To collect pre-treatment tissue specimens
Time frame: Every 6 weeks
To follow levels of pro-angiogenic cytokines
Time frame: Every 6 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 1 Mar 2018.
- Results publicationJournal of Clinical Oncology, 2009 ASCO Annual Meeting Proceedings (Post-Meeting Edition). Vol 27, No 15S (May 20 Supplement), 2009: 5101
Related trials for Renal Cell Carcinoma
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A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
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RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
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Pucotenlimab, Lenvatinib, and SBRT Before Surgery for Localized Clear Cell Renal Cell Carcinoma
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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.
Daniel Cho, MD principal investigator
Dana-Farber Cancer Institute
4 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 Renal Cell Carcinoma, run by AEterna Zentaris at 4 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 8 inclusion and 7 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 1 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 4 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?
To estimate the progression free survival (time frame: Every 6 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 NCT00448721, 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 1 Mar 2018.