AMG 386, 20060159 Phase 2, RCC 1st Line in Combination With Sorafenib
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ClinicalTrials.gov Identifier: NCT00467025 |
Recruitment Status :
Completed
First Posted : April 27, 2007
Last Update Posted : March 23, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Advanced Renal Cell Carcinoma | Drug: AMG 386 Drug: Sorafenib Drug: AMG 386 placebo IV | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 152 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Quadruple (Participant, Care Provider, 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 |
Study Start Date : | May 2007 |
Actual Primary Completion Date : | April 2010 |
Actual Study Completion Date : | June 2014 |

Arm | Intervention/treatment |
---|---|
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 Drug: AMG 386 placebo IV AMG 386 placebo IV |
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 Drug: AMG 386 placebo IV AMG 386 placebo IV |
- Progression Free Survival [ Time Frame: 2 3/4 years ]
- Objective response rate (ORR) [ Time Frame: 2 3/4 years ]
- Duration of response (DOR) [ Time Frame: 2 3/4 years ]
- Change in continuous measures of tumor burden [ Time Frame: 2 3/4 years ]
- 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 ]
- Incidence of AEs and significant laboratory changes [ Time Frame: 2 3/4 years ]
- Incidence of the occurrence of anti-AMG 386 antibody formation [ Time Frame: 2 3/4 years ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00467025
Study Director: | MD | Amgen |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Amgen |
ClinicalTrials.gov Identifier: | NCT00467025 |
Other Study ID Numbers: |
20060159 |
First Posted: | April 27, 2007 Key Record Dates |
Last Update Posted: | March 23, 2016 |
Last Verified: | February 2016 |
Metastatic clear cell carcinoma of the kidney RCC |
Carcinoma Carcinoma, Renal Cell Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma Kidney Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases Urologic Diseases |
Sorafenib Trebananib Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |