AMG 386 Phase 2 Open-Label Renal Cell Carcinoma (RCC) Study 1st Line or After Cytokine Failure in Combination With Sunitinib

NCT ID: NCT00853372

Last Updated: 2020-07-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 85 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-28
• Study Completion Date: 2019-06-25

Brief Summary

This phase 2 study is an open-label, multi-center study to determine the safety and tolerability of AMG 386 in combination with sunitinib in the treatment of subjects with metastatic renal cell carcinoma.

Conditions

Advanced Renal Cell Carcinoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Trebananib 10 mg/kg + Sunitinib

Trebananib 10 mg/kg intravenously (IV) once weekly (QW) plus sunitinib 50 mg orally (PO) once daily (QD) 4 weeks on/2 weeks off

Group Type: EXPERIMENTAL

Sunitinib

Intervention Type: DRUG

Sunitinib will be administered 50 mg QD and is considered to be the background therapy as it is licensed for treatment of reneal cell cancer (RCC) and will be administered to all participants.

Trebananib

Intervention Type: DRUG

Administered until a participant develops disease progression, clinical progression, unacceptable toxicity, withdraws consent, or death.

Trebananib 15 mg/kg + Sunitinib

Trebananib 15 mg/kg IV QW plus sunitinib 50 mg PO QD 4 weeks on/2 weeks off

Group Type: EXPERIMENTAL

Sunitinib

Intervention Type: DRUG

Sunitinib will be administered 50 mg QD and is considered to be the background therapy as it is licensed for treatment of reneal cell cancer (RCC) and will be administered to all participants.

Trebananib

Intervention Type: DRUG

Administered until a participant develops disease progression, clinical progression, unacceptable toxicity, withdraws consent, or death.

Interventions

Sunitinib

Sunitinib will be administered 50 mg QD and is considered to be the background therapy as it is licensed for treatment of reneal cell cancer (RCC) and will be administered to all participants.

Intervention Type: DRUG

Trebananib

Administered until a participant develops disease progression, clinical progression, unacceptable toxicity, withdraws consent, or death.

Intervention Type: DRUG

Other Intervention Names

SUTENT (oral multi-kinase inhibitor); AMG 386; Angiogenesis inhibitor

Eligibility Criteria

Inclusion Criteria

• Subjects must have a histologically confirmed metastatic renal cell cancer (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 Response Evaluation Criteria in Solid Tumor (RECIST) guidelines with modifications
• Adequate organ and hematological function as evidenced by laboratory studies conducted at Screening
• Eastern Cooperative Oncology Group (ECOG) of 0 or 1

Exclusion Criteria

Disease related

• Known history of central nervous system metastases.
• Previous treatment (excluding surgery, prior cytokine-based immunotherapy and palliative radiotherapy) for advanced or metastatic renal cell carcinoma
• Focal radiation therapy for palliation of pain from bony metastases within 14 days of enrollment.

Medications

• Currently or previously treated with sunitinib or other small molecule inhibitors of vascular endothelial growth factor (VEGF)
• Currently or previously treated with agents that neutralizing VEGF
• Currently or previously treated with AMG 386, or other molecules that inhibit the angiopoietins or Tie2 receptor
• Currently or previously treated with agents inhibiting the mammalian target of rapamycin (mTOR)
• Current or within 30 days prior to enrollment treatment with immune modulators
• Concomitant or previous use within 30 days prior to enrollment of any strong inducer of CYP3A4
• Concomitant or previous use of amiodarone within 6 months prior to enrollment

General medical

• Clinically significant cardiovascular disease within 12 months prior to enrollment, including myocardial infarction, unstable angina, grade 2 or greater peripheral vascular disease, cerebrovascular accident, transient ischemic attack, congestive heart failure, or arrhythmias not controlled by outpatient medication, percutaneous transluminal coronary angioplasty/stent
• Major surgery within 28 days prior to enrollment or still recovering from prior surgery
• Uncontrolled hypertension as defined as diastolic > 90 mmHg OR systolic >150 mmHg. The use of anti-hypertensive medications to control hypertension is 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amgen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

MD

Role: STUDY_DIRECTOR

Amgen

References

Atkins MB, Gravis G, Drosik K, Demkow T, Tomczak P, Wong SS, Michaelson MD, Choueiri TK, Wu B, Navale L, Warner D, Ravaud A. Trebananib (AMG 386) in Combination With Sunitinib in Patients With Metastatic Renal Cell Cancer: An Open-Label, Multicenter, Phase II Study. J Clin Oncol. 2015 Oct 20;33(30):3431-8. doi: 10.1200/JCO.2014.60.6012. Epub 2015 Aug 24.

Reference Type: DERIVED

PMID: 26304872 (View on PubMed)

Related Links

http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

20080579

Identifier Type: -

Identifier Source: org_study_id