A Phase II Study to Treat Subjects With Advanced Renal Cell Carcinoma

NCT00422019 | Completed Phase 2

• 1 other identifier: 20060100
• Study Type: interventional
• Target: 61
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the effectiveness and safety of AMG 102 in patients with Advanced Renal Cancer.

Conditions

Advanced Renal Cell Carcinoma

Keywords

Renal Cancer; Kidney Cancer

Outcome Measures

Primary Outcomes (1)

• To assess the objective response rate in subjects with advanced renal cell carcinoma receiving AMG 102 treatment

  9 weeks from first dose of AMG 102

Secondary Outcomes (4)

• To estimate the overall survival and progression free survival rates in this population

  8 week intervals

• To assess the duration of response and time to response in this population

  treatment period

• To assess the pharmacokinetics of AMG 102 in subjects with advanced renal cell carcinoma

  Weeks 1, 5, and 9

• To assess the safety profile of AMG 102 in subjects with advanced renal cell carcinoma

  entire study

Study Arms (2)

AMG 102 at 20 mg/kg Dose Level

EXPERIMENTAL

Up to 40 subjects will be treated at 20 mg/kg of AMG 102 Q2W (every 2 weeks) depending upon the stage of the study and number of responses observed.

Drug: AMG 102 at 20 mg/kg

AMG 102 at 10 mg/kg Dose Level

EXPERIMENTAL

Up to 40 subjects will be dosed at 10mg/kg of AMG 102 Q2W (every two weeks) based upon the stage of the study and number of responses observed.

Drug: AMG 102 at 10 mg/kg

Interventions

AMG 102 at 10 mg/kg DRUG

AMG 102 at 10 mg/kg IV (in the vein) every 2 weeks

AMG 102 at 10 mg/kg Dose Level

AMG 102 at 20 mg/kg DRUG

AMG 102 at 20 mg/kg IV (in the vein) every 2 weeks

AMG 102 at 20 mg/kg Dose Level

Eligibility Criteria

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

You may qualify if:

• documented histologically confirmed advanced or metastatic renal cell carcinoma with the primary tumor in place or following nephrectomy
• measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques (CT or MRI) or ≥ 10 mm by spiral CT scan
• no more than 3 relapses (or prior systemic treatments)
• unable to receive or failed prior therapy with vascular endothelial growth factor (VEGF) binding agents or VEGF receptor tyrosine kinase inhibitors or other multi-kinase inhibitors
• tissue blocks or tissue sections from initial or upon diagnosis of advanced metastatic disease are available for submission to the central laboratory within approximately 4 weeks after enrollment or approval is granted by the sponsor (upon receipt of justification why the sample is not available)
• age ≥ 18 years
• ECOG performance status of 0-2
• hemoglobin concentration ≥ 9 g/dL
• absolute neutrophil count ≥ 1.5 x 10(9th)/L
• corrected serum calcium ≤ 10 mg/dL
• either serum creatinine \< 2.0 x upper limit of normal OR creatinine clearance \> 40 mL/min
• alanine aminotransferase ≤ 2.5 times upper limit of normal or \< 5.0 x ULN if the subject has documented liver metastasis or primary hepatic neoplasm
• serum total bilirubin ≤ 2.5 times upper limit of normal
• before any study-specific procedure, the appropriate written informed consent must be obtained

You may not qualify if:

• active brain metastases; brain metastases allowed provided they have been treated with surgery and/or radiation therapy and show no evidence of progression on cerebral CT or MRI scan 2 months following surgery and/or radiation therapy
• concurrent severe and/or uncontrolled medical disease (e.g., uncontrolled diabetes, congestive cardiac failure, myocardial infarction within 6 months before enrollment) that could compromise participation in the study
• documented history of human immunodeficiency virus infection
• documented history of viral chronic hepatitis
• received biologic, small molecule, immunotherapy, chemotherapy, radiotherapy or other agents to treat renal cancer within 28 days before enrollment
• treated previously with c-Met or HGF targeted therapy
• concurrent or prior (within 7 days before enrollment) anticoagulation therapy, except:
• Use of low-dose warfarin (\< 2 mg/day) for prophylaxis against central venous catheter thrombosis or
• Use of low molecular weight heparins (LMWH, e.g., enoxaparin sodium \[Lovenox\] and unfractionated heparin for prophylaxis against central venous catheter thrombosis is allowed
• concurrent use of hormones or other chemotherapeutic agents except for steroids given for adrenal failure and hormones administered for non-disease-related conditions (eg, insulin for diabetes); except for non-cancer reasons
• concurrent palliative or therapeutic radiation therapy
• currently enrolled in or has not yet completed at least 30 days since ending other investigational device or therapy, or subject is receiving other investigational agent(s)
• active infection requiring treatment within 1 week before enrollment
• undergone major surgery within 4 weeks before enrollment or recovering from prior surgery
• past or current history of another neoplasm, except for curatively treated non-melanoma skin cancer, carcinoma in situ of the cervix and other primary solid cancer with no known active disease present and no curative treatment administered for the last 3 years

Sponsors & Collaborators

• Amgen: lead

Related Publications (1)

• Schoffski P, Garcia JA, Stadler WM, Gil T, Jonasch E, Tagawa ST, Smitt M, Yang X, Oliner KS, Anderson A, Zhu M, Kabbinavar F. A phase II study of the efficacy and safety of AMG 102 in patients with metastatic renal cell carcinoma. BJU Int. 2011 Sep;108(5):679-86. doi: 10.1111/j.1464-410X.2010.09947.x. Epub 2010 Dec 13.

  PMID: 21156020 BACKGROUND

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Kidney Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2007
• First Posted: January 15, 2007
• Study Start: January 1, 2007
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: April 10, 2015

Record last verified: 2015-03