NCT00448721

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2007

Typical duration for phase_2

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

March 15, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 19, 2007

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

March 1, 2018

Status Verified

February 1, 2012

Enrollment Period

3.6 years

First QC Date

March 15, 2007

Last Update Submit

February 27, 2018

Conditions

Renal Cell Carcinoma

Keywords

renal cell carcinomatyrosine kinase inhibitor failure

Outcome Measures

Primary Outcomes (1)

  • 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

    Every 6 weeks

Secondary Outcomes (5)

  • To determine the objective response rate of perifosine

    Every 6 weeks

  • To investigate the tolerability and toxicity

    Every 6 weeks

  • To investigate surrogates of biologic target inhibition

    Every 6 weeks

  • To collect pre-treatment tissue specimens

    Every 6 weeks

  • To follow levels of pro-angiogenic cytokines

    Every 6 weeks

Study Arms (1)

Perifosine

EXPERIMENTAL

Perifosine will be administered orally at 100mg PO daily with food. One treatment cycle will consist of 42 days (6 weeks).

Drug: Perifosine

Interventions

PerifosineDRUG

Perifosine will be administered orally at 100mg PO daily with food.

Also known as: D-21266, KRX-0401
Perifosine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Investigative Site

Duarte, California, 91010, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Investigative Site

Philadelphia, Pennsylvania, 19104, United States

Location

Investigative Site

Nashville, Tennessee, 37232, United States

Location

Related Publications (1)

  • Journal of Clinical Oncology, 2009 ASCO Annual Meeting Proceedings (Post-Meeting Edition). Vol 27, No 15S (May 20 Supplement), 2009: 5101

    RESULT

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

perifosine

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Daniel Cho, MD

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2007

First Posted

March 19, 2007

Study Start

March 1, 2007

Primary Completion

October 1, 2010

Study Completion

October 1, 2011

Last Updated

March 1, 2018

Record last verified: 2012-02

Locations

US(4)