Ph II Study of Perifosine for Patients With Carcinoma of the Kidney

NCT00498966 | Completed Phase 2

• 1 other identifier: Perifosine 231
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

Brief Summary

This is a Phase II study. Patients with kidney carcinoma will be considered in two groups. The goals of this study are:

• To measure clinical benefit defined as tumor response or progression-free survival for more than 12 weeks in patients with metastatic carcinoma of the kidney who have failed or have progressed on a VEGF receptor inhibitor
• To evaluate the safety of perifosine in patients with metastatic carcinoma of the kidney who have failed or have progressed on a VEGF receptor inhibitor

Conditions

Kidney Cancer

Keywords

Kidney; perifosine; Progression on treatment with sunitinib or sorafenib

Outcome Measures

Primary Outcomes (1)

• Objective tumor response using RESIST OR progression-free survival

  Clinical benefit, defined as either an objective response by RECIST or PFS \>12 weeks, is a primary endpoint of the study. The clinical benefit rate together with its two-sided exact binomial 95% confidence interval will be reported.

  12 weeks

Secondary Outcomes (1)

• Evaluate the safety of perifosine in patients with metastatic carcinoma of the kidney

  12 weeks

Study Arms (2)

Group A

EXPERIMENTAL

Patients in group A will have previously failed a VEGF receptor inhibitor but not an mTOR inhibitor.Intervention: Perifosine.

Drug: Perifosine

Group B

EXPERIMENTAL

Patients in group B will have failed both a VEGF receptor inhibitor and an mTOR inhibitor. Intervention: Perifosine.

Drug: Perifosine

Interventions

Perifosine DRUG

Perifosine 100 mg PO Perifosine is supplied as a film-coated tablet containing 50 mg of active ingredient. Treatment will be administered on an outpatient basis in 28-day cycles. The patient dose for daily administration will be 100 mg qhs daily with food.

Also known as: D-21266, KRX-0401

Group A; Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with confirmed metastatic RCC
• Patients must have documented progression on treatment with sunitinib or sorafenib. Prior therapy with bevacizumab and/or cytokines (i.e., IL-2, interferon) is permitted. Prior vaccine therapy in the adjuvant setting is also permitted. Patients can have failed therapy with ONE prior mTOR inhibitor.
• Patients must have at least one measurable lesion on computer tomography (CT) Scan or magnetic resonance imaging (MRI) using Modified RECIST criteria.
• Patients must have normal organ and marrow function, unless in the opinion of the treating investigator, the abnormality is related to tumor, and the study chairman agree the abnormality is unlikely to affect the safety of perifosine use. Normal organ and marrow function is described below:
• ANC \>= 1.5 x 109/L
• Platelets \>= 75,000/ mm3
• HCT \>= 28% (with or without growth factor support)
• Creatinine \<= 3.0 mg/dl
• Total bilirubin \<= 1.5 x upper limit of normal
• Transaminase \<= 2.5 x upper limit of normal
• ECOG performance status of 0 or 1
• Patients with CNS metastases must be clinically stable for at least 2 months following treatment with radiation therapy, surgery, or both; and be off corticosteroids and anti-seizure medication.
• Patients with a life expectancy ≥6 months
• Age ≥18 years old
• Patients who give a written informed consent obtained according to local guidelines

You may not qualify if:

• Patients who have not recovered (\<= grade 1) from adverse events from prior therapy (excluding alopecia).
• Patients currently receiving sorafenib or sunitinib who have received either of these within 2 weeks prior to study entry.
• Patients may have had prior sorafenib OR sunitinib BUT cannot have been treated with both VEGF receptor inhibitors.
• Patients with a known hypersensitivity to perifosine or its excipients.
• Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods.
• Patients who are using other investigational agents or who had received investigational drugs \<= 4 weeks prior to study entry.
• Patients unwilling to or unable to comply with the protocol.
• Patients who have a history of another primary malignancy \<= 5 years with the exceptions of non melanomatous skin cancer and carcinoma in situ of the cervix.

Sponsors & Collaborators

• AEterna Zentaris: lead

Study Sites (3)

Investigative Site

Louisville, Kentucky, 40202, United States

Location

Investigative Site

Morristown, New Jersey, 07962, United States

Location

Investigative Site

Armonk, New York, 10504, 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

Kidney Neoplasms

Interventions

perifosine

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Nicholas J Vogelzang, MD

  Nevada Cancer Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Two groups with regard to pre-treatment: patients in group A will have previously failed a VEGF receptor inhibitor but not an mTOR inhibitor, while patients in group B will have failed both a VEGF receptor inhibitor and an mTOR inhibitor. One treatment group: all patients will receive perifosine 100 mg qhs daily orally. Patients are to be instructed that perifosine is to be taken with food.

Study Record Dates

• First Submitted: July 9, 2007
• First Posted: July 11, 2007
• Study Start: July 1, 2007
• Primary Completion: July 1, 2011
• Study Completion: October 1, 2011
• Last Updated: February 5, 2018

Record last verified: 2018-02

Locations

US (3)