AMG 386, 20060159 Phase 2, RCC 1st Line in Combination With Sorafenib

Advanced Renal Cell Carcinoma Clinical Trial

Official title:

A Randomized, Double Blinded, Multi-Center Phase 2 Study to Estimate the Efficacy and Evaluate the Safety and Tolerability of Sorafenib in Combination With AMG 386 or Placebo In Subjects With Metastatic Clear Cell Carcinoma of the Kidney

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00467025
• Other study ID #: 20060159
• Status: Completed
• Phase: Phase 2
• First received: April 26, 2007
• Last updated: September 8, 2015
• Start date: May 2007
• Est. completion date: September 2014

Study information

• Verified date: August 2015
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: AGES - PharmaMed Austria Institut Wissenschaft & InformationAustria: Bundesamt für Sicherheit im GesundheitswesenBelgium: Directorate-General for Medicinal ProductsFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsSpain: Agencia Española de Medicamentos y Productos SanitariosUnited States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This is a phase 2, randomized, double-blind, placebo controlled, multi-center study to estimate the improvement in progression free survival (PFS) and evaluate the safety and tolerability of AMG 386 in combination with sorafenib in the treatment of subjects with advanced clear cell carcinoma of the kidney.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: September 2014
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects must have a histologically confirmed metastatic RCC with a clear cell component

• Low or intermediate risk according to the Memorial Sloan Kettering Cancer Center (MSKCC) prognostic risk classification.

• Measurable disease with at least one unidimensionally measurable lesion per RECIST guidelines with modifications

• Adequate organ and hematological function as evidenced by laboratory studies conducted at Screening.

• ECOG of 0 or 1

Exclusion Criteria:

Disease Related

• Known history of central nervous system metastases.

• Previous treatment (excluding surgery and palliative radiotherapy) for advanced or metastatic renal cell carcinoma

• Focal radiation therapy for palliation of pain from bony metastases within 14 days of randomization.

Medications

• Currently or previously treated with inhibitors of VEGF.

• Currently or previously treated with inhibitors of angiopoietin or Tie2.

• Currently or previously treated with bevacizumab.

General Medical

• Diagnosis of acute pancreatitis.

• Myocardial infarction, cerebrovascular accident, transient ischemic attack, percutaneous transluminal coronary angioplasty/stent, congestive heart failure, grade 2 or greater peripheral vascular disease, arrhythmias not controlled by outpatient medication, or unstable angina within 1 year prior to randomization

• Major surgery within 30 days before randomization or still recovering from prior surgery

• Uncontrolled hypertension as defined as diastolic > 90 mmHg OR systolic >150 mmHg. Anti-hypertensive medications are permitted.

Other

• Other investigational procedures are excluded

• Subject currently is enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study(s), or subject is receiving other investigational agent(s)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Renal Cell Carcinoma
• Carcinoma
• Carcinoma, Renal Cell

Intervention

Drug:
• AMG 386
3 mg/kg or 10mg/kg IV weekly until unacceptable toxicity or disease progression
• Sorafenib
400 mg PO BID
• AMG 386 placebo IV
AMG 386 placebo IV

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival		2 3/4 years	No
Secondary	Objective response rate (ORR)		2 3/4 years	No
Secondary	Duration of response (DOR)		2 3/4 years	No
Secondary	Change in continuous measures of tumor burden		2 3/4 years	No
Secondary	Time-adjusted area under the curve (AUC) for the FACT-Kidney Cancer Symptom Index (FKSI-15) scale score from baseline through disease progression with imputation for missing data		2 3/4 years	No
Secondary	Incidence of AEs and significant laboratory changes		2 3/4 years	Yes
Secondary	Incidence of the occurrence of anti-AMG 386 antibody formation		2 3/4 years	Yes

External Links

•   AmgenTrials clinical trials website