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Renal CancerPhase 1NCT00399152

Perifosine + Sunitinib Malate for Patients With Advanced Cancers

A Phase 1 study testing Perifosine and Sunitinib Malate in people with Renal Cancer and GIST, run by AEterna Zentaris.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is a Phase I trial in two parts. In part 1, a MTD to the combination of perifosine and sunitinib malate 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 two courses of therapy, which… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Renal Cancer, GIST
What is being tested?
Perifosine and Sunitinib Malate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
No sites listed yet
Study dates
Oct 2006to Oct 2009
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 tumor or GIST are eligible for this protocol. Patients with other solid tumor types must have their cases reviewed by the OCOG 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 sunitinib malate 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. However, patients with ECOG performance status of 2 may be admitted with approval from the study chairman or medical monitor.
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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 study chairman or medical monitor agree the abnormality is unlikely to affect the safety of perifosine and/or sunitinib use.
  • Patients must have recovered from acute toxicity related to prior therapy including surgery or radiotherapy, excluding alopecia.
  • 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.
  • LVEF greater than or equal to 50%.

Who cannot join

  • Rapidly progressing disease, as defined by progression within 8 weeks of initiation of the previous regimen
  • 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 a 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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  • Patients currently taking strong inhibitors of the CYP3A4 family (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole) AND inducers of the CYP3A4 family (e.g., dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbital, St. John's Wort) because of possible pharmacokinetic interactions with sunitinib. Patients who are no longer taking strong CYP3A4 inhibitors and/or inducers are ineligible unless they have discontinued use 4 weeks prior to beginning therapy.
  • 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. 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 to prevent pregnancy while on therapy and for 4 weeks after the completion of treatment.

About this study

Official title: An Open-Label Phase I Study of the Safety of Perifosine in Combination With Sunitinib Malate 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 sunitinib malate 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 two 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 sunitinib malate will be determined. In some previous trials with perifosine and other biologic agents, 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 two courses of therapy, which would make them evaluable for response in a Phase II study. As a secondary endpoint, the effects of the combination of perifosine and sunitinib malate 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 6 weeks. Patients will take one 50 mg tablet of perifosine one to three times a day and sunitinib malate once a day for 4 out of 6 weeks. Patients may need anti-emetics and/or anti-diarrheals. Patients will be evaluated for progression or response at 12-week intervals.

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 at least four weeks apart.

Part 1 of this Phase I study will accrue from six to 24 patients depending on the number of dose levels evaluated. Up to six patients will be treated at each dose level. A dose limiting toxicity (DLT) will be defined as:

  • Grade 3 or greater non-hematologic toxicity
  • Grade 4 hematologic toxicity
Conditions
Renal Cancer, GIST
Being tested
Perifosine, Sunitinib Malate
Keywords
Perifosine, Sunitinib Malate, Renal cancer, GIST, advanced cancers
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

    Perifosine Oral Dose

  • Sunitinib MalateDrug

    Sunitinib oral dose

Study groups in NCT00399152
Study groupRoleWhat they receive
Perifosine+Sunitinib malateExperimentalNot described
Receives: Drug: Perifosine; Drug: Sunitinib Malate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Toxicities

    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.

  1. First posted14 Nov 2006 (estimated)
  2. Study startOct 2006
  3. Primary completionDec 2008
  4. Study completionOct 2009

Resources

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
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00399152
Sponsor's protocol ID
Perifosine 125
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: 14565

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Perifosine and Sunitinib Malate in people with Renal Cancer and GIST, 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 10 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?

Toxicities (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 NCT00399152, 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.

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