AMG 386, 20060159 Phase 2, RCC 1st Line in Combination With Sorafenib
This study is ongoing, but not recruiting participants.
Sponsor:
Amgen
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00467025
First received: April 26, 2007
Last updated: November 27, 2012
Last verified: November 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Advanced Renal Cell Carcinoma |
Drug: AMG 386 Drug: Sorafenib |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Amgen:
Primary Outcome Measures:
- Progression Free Survival [ Time Frame: 2 3/4 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Objective response rate (ORR) [ Time Frame: 2 3/4 years ] [ Designated as safety issue: No ]
- Duration of response (DOR) [ Time Frame: 2 3/4 years ] [ Designated as safety issue: No ]
- Change in continuous measures of tumor burden [ Time Frame: 2 3/4 years ] [ Designated as safety issue: No ]
- 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 [ Time Frame: 2 3/4 years ] [ Designated as safety issue: No ]
- Incidence of AEs and significant laboratory changes [ Time Frame: 2 3/4 years ] [ Designated as safety issue: Yes ]
- Incidence of the occurrence of anti-AMG 386 antibody formation [ Time Frame: 2 3/4 years ] [ Designated as safety issue: Yes ]
| Enrollment: | 152 |
| Study Start Date: | May 2007 |
| Estimated Study Completion Date: | September 2013 |
| Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Arm A |
Drug: AMG 386
3 mg/kg or 10mg/kg IV weekly until unacceptable toxicity or disease progression
Drug: Sorafenib
400 mg PO BID
|
| Experimental: Arm B |
Drug: AMG 386
3 mg/kg or 10mg/kg IV weekly until unacceptable toxicity or disease progression
Drug: Sorafenib
400 mg PO BID
|
| Active Comparator: Arm C |
Drug: Sorafenib
400 mg PO BID
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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)
Contacts and Locations More Information
Additional Information:
No publications provided by Amgen
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Amgen |
| ClinicalTrials.gov Identifier: | NCT00467025 History of Changes |
| Other Study ID Numbers: | 20060159 |
| Study First Received: | April 26, 2007 |
| Last Updated: | November 27, 2012 |
| Health Authority: | Austria: AGES - PharmaMed Austria Institut Wissenschaft & Information Austria: Bundesamt für Sicherheit im Gesundheitswesen Belgium: Directorate-General for Medicinal Products France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Spain: Agencia Española de Medicamentos y Productos Sanitarios United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by Amgen:
|
Metastatic clear cell carcinoma of the kidney RCC |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Renal Cell Adenocarcinoma, Clear Cell Adenomyoepithelioma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma Kidney Neoplasms Urologic Neoplasms Urogenital Neoplasms |
Neoplasms by Site Kidney Diseases Urologic Diseases Neoplasms, Complex and Mixed Sorafenib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 21, 2013