Back to results

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

Primary Purpose

Kidney Cancer

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Perifosine

About this trial

This is an interventional treatment trial for Kidney Cancer focused on measuring Kidney, perifosine, Progression on treatment with sunitinib or sorafenib

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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
Women of childbearing potential must have had a negative serum or urine pregnancy test 72 hours prior to the administration of the first study treatment.

Exclusion Criteria:

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.

Sites / Locations

Investigative Site
Investigative Site
Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Group A

Group B

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Safety endpoints include: incidence of adverse events, serious adverse events, change in vital signs and change in laboratory results (hematology, blood chemistry, urinalysis).

Full Information

NCT ID

NCT00498966

First Posted

July 9, 2007

Last Updated

February 2, 2018

Sponsor

AEterna Zentaris

1. Study Identification

Unique Protocol Identification Number

NCT00498966

Brief Title

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

Official Title

Phase II Study of Perifosine for Patients With Metastatic Carcinoma of the Kidney Who Have Progressed on a VEGF Receptor Inhibitor

Study Type

Interventional

2. Study Status

Record Verification Date

February 2018

Overall Recruitment Status

Completed

Study Start Date

July 2007 (undefined)

Primary Completion Date

July 2011 (Actual)

Study Completion Date

October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AEterna Zentaris

4. Oversight

Data Monitoring Committee

5. Study Description

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

Detailed Description

This is a Phase II study. Patients with kidney carcinoma will be considered in two groups. 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. Evaluation of each group will be performed separately. The goals of this study are: To measure clinical benefit defined as an objective tumor response using RESIST 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. Treatment Phase/duration of treatment: All patients will be treated with daily perifosine at 100 mg PO daily until tumor progression (by the RECIST criteria) or unacceptable toxicity. Once radiological disease progression has been documented by the treating physician, the patient will go off study. Patients are encouraged to have two measurements for confirmation of progression. Follow-Up Phase: All patients will be followed-up for SAEs until at least 30 days after discontinuation of perifosine. All patients who are discontinued from perifosine for any reason other than disease progression will continue to have tumor assessments until the patient has documented disease progression or has begun other therapies.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Kidney Cancer

Keywords

Kidney, perifosine, Progression on treatment with sunitinib or sorafenib

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

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.

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group A

Arm Type

Experimental

Arm Description

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

Arm Title

Group B

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Perifosine

Other Intervention Name(s)

D-21266, KRX-0401

Intervention Description

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.

Primary Outcome Measure Information:

Title

Objective tumor response using RESIST OR progression-free survival

Description

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

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

Description

Safety endpoints include: incidence of adverse events, serious adverse events, change in vital signs and change in laboratory results (hematology, blood chemistry, urinalysis).

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Women of childbearing potential must have had a negative serum or urine pregnancy test 72 hours prior to the administration of the first study treatment. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nicholas J Vogelzang, MD

Organizational Affiliation

Nevada Cancer Institute

Official's Role

Study Chair

Facility Information:

Facility Name

Investigative Site

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40202

Country

United States

Facility Name

Investigative Site

City

Morristown

State/Province

New Jersey

ZIP/Postal Code

07962

Country

United States

Facility Name

Investigative Site

City

Armonk

State/Province

New York

ZIP/Postal Code

10504

Country

United States

12. IPD Sharing Statement

Citations:

Citation

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

Results Reference

result

Learn more about this trial

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

We'll reach out to this number within 24 hrs