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TumorsPhase 2NCT00389077

Trial of Two Schedules of Perifosine for Patients With Solid Tumors or Lymphomas

A Phase 2 study testing Perifosine in people with Tumors and Lymphomas, 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 is a study of the drug perifosine for patients who have no standard treatment options. This study is designed to identify which cancer types respond to perifosine, and determine which regimen of perifosine is most effective in each one. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Tumors, Lymphomas
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
558 participants
Where
No sites listed yet
Study dates
Jan 2005to Sep 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 must have a histologically or cytologically confirmed diagnosis of either a lymphoma or solid tumor for which there is no established therapy that, in the opinion of the treating physician, will prolong the patient's survival or have a larger net effect on the patient's quality of life.
  • 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 at least 12 weeks even if there were a transient period of modest tumor growth (defined as less than 30%) during the first weeks following the initiation of perifosine treatment.
  • Patients must have a life expectancy of more than 6 months.
  • Patients must not be eligible for any other available perifosine study.
  • In general, patients should have received no more than two prior cytotoxic chemotherapy regimens for metastatic disease.
  • Patients may have measurable or non-measurable disease. If the outcome for a patient is to be based on response using Response Evaluation Criteria in Solid Tumors (RECIST) criteria, the patient must have at least one measurable lesion that can be accurately measured in at least one dimension and fit one of the following criteria: longest diameter >= 20 mm using conventional techniques or >= 10 mm with spiral computed tomography (CT) scan. The dimensions of all target lesions that will be used to determine objective response along with the date of last measurement and the method of measurement (e.g. physical examination, spiral CT, conventional CT) must be recorded on the enrollment form prior to the patient's first treatment.
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  • If the outcome for a patient is to be based on an increase in time to progression, the following will apply:
  • The time to progression on the systemic treatment administered just prior to enrollment in this trial must be carefully documented and should be 12 weeks or more.
  • There must have been a baseline tumor evaluation in which all sites of likely metastases, based on signs and symptoms, were evaluated at the beginning of this pre-protocol baseline time interval. (A total body CT scan or magnetic resonance imaging [MRI] will usually suffice but are not required to meet this criterion).
  • During the 12+ weeks in which the patient was progression-free, there must have been no symptoms or signs of new metastases that warranted an evaluation, undertaken or not.
  • Progression of prior metastases or the appearance of new metastases must be documented at the end of the progression-free 12+ week period.
  • This prior progression-free interval must be recorded on the enrollment case report form prior to the patient's first treatment.
  • Patients should have a performance status of 0 to 1 according to the ECOG criteria.
  • Patients must have adequate organ and marrow function. Adequate organ and marrow function are described below.
  • hematocrit (HCT) >= 28% (with or without growth factor support)
  • creatinine <= 2.5 mg/dl
  • total bilirubin <= 1.5x upper limit of normal
  • transaminase <= 2.5x upper limit of normal
  • 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 into 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
  • Patients receiving any other investigational agents or devices
  • Patients who have recently (within 8 weeks) begun a new cancer treatment (e.g., bisphosphonates) that 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
  • 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: A Phase IIA Trial of Two Schedules of Perifosine

This is a study of the drug perifosine for patients who have no standard treatment options. This study is designed to identify which cancer types respond to perifosine, and determine which regimen of perifosine is most effective in each one. Patients with either solid tumors or with lymphomas for whom this protocol represents reasonable or optimal treatment will be randomized to receive either perifosine 100 mg daily or 900 mg weekly until disease progression. Based on currently available data it is anticipated that these doses should be easily tolerated by most patients.

Read the detailed description

This is an exploratory phase IIA trial with unique elements of design and patient selection with an aim to:

  • Identify responsive tumor types that were not predicted from preclinical and Phase I studies,
  • Determine if tumors are more likely to stabilize than shrink, and
  • Identify a dose with almost no toxicity.
  • To determine whether response (or stabilization) can be observed on either a daily or weekly schedule, or both. Since the efficacy goal of the study is to look for any evidence of activity with perifosine, the daily and weekly arms will be combined when assessing response.
  • Response to therapy will be based on either tumor regression (objective response, partial or complete) OR stabilization of disease.

It is not anticipated that this study will provide "proof of principle" regarding the use of perifosine or serve as a pivotal trial for regulatory purposes. Information obtained from this study will be used to design additional trials that will be more definitive in nature.

Conditions
Tumors, Lymphomas
Being tested
Perifosine
Keywords
perifosine, solid tumors, lymphomas, anticancer agent
Medical subject headings
Neoplasms, Lymphoma

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 50 mg tablets

Study groups in NCT00389077
Study groupRoleWhat they receive
Perifosine Daily DoseExperimentalDaily dose perifosine 50 mg.
Receives: Drug: Perifosine
Perifosine Twice Daily DoseExperimentalTwice daily dose perifosine 50 mg.
Receives: Drug: Perifosine

What is being measured

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

  1. Overall Response Rate (PR + CR)

    To determine for each disease category the proportion of patients treated with perifosine who experience a favorable outcome, defined as a complete or partial response; a 50% increase in progression-free survival compared to patient's latest treatment regimen for metastatic disease, or stabilization of disease.

    Measured: Evaluated every 12 weeks

Secondary outcomes (2)

  1. To Show that doses will be each sufficiently and tolerated

    To show that daily 50 mg daily and 50 mg twice-daily doses are each sufficiently well tolerated to ensure good compliance in future studies of these two regimens

    Measured: From date of randomization

  2. To obtain plasma levels

    To obtain perifosine plasma levels in a subset of patients to evaluate variability in drug uptake between patients, and to correlate plasma levels with outcomes to insure good compliance in future studies of these two regimens

    Measured: Every treatment cycle

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Oct 2006 (estimated)
  2. Study startJan 2005
  3. Primary completionJul 2011
  4. Study completionSep 2011

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
558 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00389077
Sponsor's protocol ID
Perifosine 207
Status last verified
Nov 2011
First submitted
16 Oct 2006
Last updated
7 Mar 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • 1) Journal of Clinical Oncology, 2009 ASCO Annual Meeting Proceedings (Post-Meeting Edition). Vol 27, No 15S (May 20 Supplement), 2009: e15505 / For HCC ( hepatic / sub-population) 2) Journal of Clinical Oncology, 2007 ASCO Annual Meeting Proceedings (Post-Meeting Edition). Vol 25, No 18S (June 20 Supplement), 2007: 15622 / For RCC (renal / sub-population)

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Perifosine in people with Tumors and Lymphomas, 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 23 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 7 Mar 2018. 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 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?

Overall Response Rate (PR + CR) (time frame: Evaluated every 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 NCT00389077, 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 7 Mar 2018.

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