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

NCT00467025 | Completed Phase 2

• 1 other identifier: 20060159
• Study Type: interventional
• Target: 152
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Advanced Renal Cell Carcinoma

Keywords

Metastatic clear cell carcinoma of the kidney; RCC

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival

  2 3/4 years

Secondary Outcomes (6)

• Objective response rate (ORR)

  2 3/4 years

• Duration of response (DOR)

  2 3/4 years

• Change in continuous measures of tumor burden

  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

  2 3/4 years

• Incidence of AEs and significant laboratory changes

  2 3/4 years

Study Arms (3)

Arm A

EXPERIMENTAL

Drug: AMG 386; Drug: Sorafenib; Drug: AMG 386 placebo IV

Arm B

EXPERIMENTAL

Drug: AMG 386; Drug: Sorafenib

Arm C

ACTIVE COMPARATOR

Drug: Sorafenib; Drug: AMG 386 placebo IV

Interventions

AMG 386 DRUG

3 mg/kg or 10mg/kg IV weekly until unacceptable toxicity or disease progression

Arm A; Arm B

Sorafenib DRUG

400 mg PO BID

Arm A; Arm B; Arm C

AMG 386 placebo IV DRUG

AMG 386 placebo IV

Arm A; Arm C

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amgen: lead

Related Publications (1)

• Rini B, Szczylik C, Tannir NM, Koralewski P, Tomczak P, Deptala A, Dirix LY, Fishman M, Ramlau R, Ravaud A, Rogowski W, Kracht K, Sun YN, Bass MB, Puhlmann M, Escudier B. AMG 386 in combination with sorafenib in patients with metastatic clear cell carcinoma of the kidney: a randomized, double-blind, placebo-controlled, phase 2 study. Cancer. 2012 Dec 15;118(24):6152-61. doi: 10.1002/cncr.27632. Epub 2012 Jun 12.

  PMID: 22692704 DERIVED

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

trebananib; Sorafenib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2007
• First Posted: April 27, 2007
• Study Start: May 1, 2007
• Primary Completion: April 1, 2010
• Study Completion: June 1, 2014
• Last Updated: March 23, 2016

Record last verified: 2016-02