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Colon CancerPhase 1NCT01048580

Study of Perifosine + Capecitabine for Colon Cancer Patients

A Phase 1 study testing Perifosine and Capecitabine in people with Colon Cancer, 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 Phase I study of Perifosine + Capecitabine for patients with advanced colon cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colon Cancer
What is being tested?
Perifosine and Capecitabine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
No sites listed yet
Study dates
Oct 2009to 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 3rd line or > metastatic colon cancer
  • Patients must have received or not be candidates for regimens containing 5- FU, oxaliplatin, irinotecan, bevacizumab, and cetuximab or panitumumab
  • No prior exposure to perifosine
  • Adequate bone marrow, liver, and renal function
  • Patients must have at least one measurable lesion
  • Patients must agree to have extra blood drawn for PK analyses

Who cannot join

  • Patients with prior exposure to perifosine.
  • Patients receiving any other investigational agents or devices.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to perifosine (miltefosine or edelfosine).
  • Patients with known dipyrimidine dehydrogenase (DPD) deficiency or prior severe reaction to 5-FU.
  • Patients with known central nervous system CNS metastases.
  • Patients with known HIV, Hepatitis B, or Hepatitis C seropositivity.
Show all 9Show fewer
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection and psychiatric illness/social situations that would limit compliance with study requirements.
  • 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 I Study of Perifosine + Capecitabine for Patients With Advanced Colon Cancer

This is a Phase I study of Perifosine + Capecitabine for patients with advanced colon cancer.

Read the detailed description

This study is a Phase I trial. A total of 3 - 9 patients will be enrolled. Three patients will initially be enrolled. There will be no dose escalation in this study as only one dose for perifosine (50 mg) in combination with one dose of capecitabine (1000 mg/m2 BID) will be evaluated. The maximum tolerated dose (MTD) is defined in which fewer than 33% of patients experienced DLT attributable to the study drug(s), when at least six patients have been treated at that dose and are evaluable for toxicity. Pharmacokinetic (PK) data will also be evaluated from all enrolled patients.

Conditions
Colon Cancer
Being tested
Perifosine, Capecitabine
Keywords
Perifosine, Capecitabine, Colon Cancer
Medical subject headings
Colonic 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 50 mg orally once a day (Days 1-21)

  • CapecitabineDrug

    Also called Xeloda

    Capecitabine 1000 mg/m2 orally twice per day (Days 1-14)

Study groups in NCT01048580
Study groupRoleWhat they receive
Perifosine +CapecitabineExperimentalOne cycle of therapy will be defined as 3 weeks (21 days). Perifosine 50 mg qd (Days 1-21) + Capecitabine 1000 mg/m2 BID (Days 1-14).
Receives: Drug: Perifosine; Drug: Capecitabine

What is being measured

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

  1. Safety and tolerability of the combination of perifosine and capecitabine (i.e., dose limiting toxicity)

    The maximum tolerated dose (MTD) is defined in which fewer than 33% of patients experienced dose limiting toxicity (DLT) attributable to the study drug(s), when at least six patients were treated at that dose and are evaluable for toxicity. A DLT will be defined as any of the following deemed to be related to study drug(s):

    • Grade 3 non-hematologic toxicity except alopecia not reversible to Grade 2 or less within 96 hours
    • Any Grade 4 toxicity DLT will be based on the first cycle of treatment (first 21 days). Toxicity will be graded according to the NCI CTCAE version 3.0. To be evaluable for toxicity, a patient must receive at least 1 complete course of treatment or have experienced DLT.

    Measured: Every 3 weeks after dosing

Secondary outcomes (3)

  1. Best overall response

    The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started).

    Response Evaluation Criteria in solid tumors (RECIST): Measurable disease is defined as the presence of at least one measurable lesion. Measurable lesions are lesions that can be accurately measured in at least one dimension and fit one of the following criteria:

    1. Longest diameter ≥ 20 mm using conventional techniques, or
    2. ≥ 10 mm with spiral CT scan.

    Measured: Every 3 cycles after dosing (length of one cycle is 21 days)

  2. Time to progression

    This is the interval from the initiation of treatment to the time of documented, objective progression using the same methods of evaluation that were used at baseline.

    In order for a patient to be regarded as having progressive disease, the following criteria must be met:

    1. The site of disease must have been evaluated either at baseline or while receiving study medication. Both evaluations must use the same methodology.
    2. PET scan results will not be used as evidence of either progression or response..

    Measured: Every 3 cycles after dosing (length of one cycle is 21 days)

  3. Pharmacokinetic (PK) data for the combination of perifosine and capecitabine

    PK data will also be evaluated from all enrolled patients. PK analyses will present peak plasma concentrations (Cmax) as well as Area under the plasma concentration verus time curve (AUC).

    Measured: Up to cyle 5 no pharmacokinetic samples were obtained. Cycle 1/Day 11 until Cycle 4/Day 11: pharmacokinetic samples obtained 0.5, 1, 2, 4, 6 and 8 hours after dosing

Timeline

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

  1. First posted13 Jan 2010 (estimated)
  2. Study startOct 2009
  3. Primary completionMay 2011
  4. Study completionOct 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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01048580
Sponsor's protocol ID
Perifosine 141
Status last verified
Nov 2011
First submitted
9 Jan 2010
Last updated
28 Jun 2018
Results posted
No
Data monitoring committee
No

Publications

  • Journal of Oncology, 2010 ASCO Annual Meeting Abstracts. Vol. 28, No. 15_suppl (May 20Supplement), 2010:e14086

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Perifosine and Capecitabine in people with Colon Cancer, 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 6 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 28 Jun 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 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?

Safety and tolerability of the combination of perifosine and capecitabine (i.e., dose limiting toxicity) (time frame: Every 3 weeks after dosing). 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 NCT01048580, 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 28 Jun 2018.

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