A Rollover Protocol for Subjects Previously Treated With AGS-003

Stopped early · Phase 2

Conditions studied: Renal Cell Carcinoma

In brief

The purpose of this study is to evaluate clinical response to AGS-003 alone or in combination with sunitinib therapy.

Key facts

Study ID

NCT01482949

Run by

Argos Therapeutics

People needed

2

Starts

2011-09-01

Expected to finish

2018-05-01

Last updated by the study team

2018-06-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years
• Subjects are receiving ongoing treatment with AGS-003 in protocol AGS- 003-004 or AGS-003-006.
• Measurable disease that can be monitored per RECIST throughout the course of study participation.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Adequate hematologic function, as defined by the following criteria:
• White blood cell (WBC) ≥ 4000/µL (≥ 4.0 x 103/µL)
• Absolute neutrophil count (ANC) ≥ 1500/µL (≥ 1.5 x 103/µL)
• Platelets ≥ 100,000/µL (≥ 100 x 103/µL)
• Hemoglobin (Hgb) ≥ 9.0 g/dL
• Adequate renal and hepatic function, as defined by the following criteria:
• Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or, if serum creatinine > 1.5 x ULN, estimated glomerular filtration rate (eGFR) ≥ 30 mL/min
• Total serum bilirubin ≤ 1.5 x ULN
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN, or AST and ALT ≤ 5 x ULN if liver function abnormalities are due to underlying malignancy
• Adequate coagulation function as defined by the following criteria:
• Prothrombin time (PT) ≤ 1.5 x ULN
• Activated partial thromboplastin time (PTT) < 1.5 x ULN
• Corrected calcium ≤ 11.5 mg/dL
• Negative serum pregnancy test for female subjects with reproductive potential, and agreement of all male and female subjects of reproductive potential to use a reliable form of contraception during the study and for 12 weeks after the last dose of study drug
• Able to abstain from taking prohibited drugs, either prescription or non- prescription, during the treatment phase of the study
• Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
• Signed and dated informed consent document indicating that the subject (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment
• No brain metastases detected by magnetic resonance imaging (MRI).

You may not qualify if…

• Any serious medical condition considered by the investigator to constitute an unwarranted high risk for investigational treatment
• History of or known brain metastases, spinal cord compression, or carcinomatous meningitis, or evidence of brain or leptomeningeal disease on screening computed tomography (CT) scan or MRI
• Pregnancy or breastfeeding
• Active autoimmune disease or condition requiring chronic immunosuppressive therapy
• NOTE: Abnormal laboratory values for autoimmunity markers in the absence of other signs/symptoms of autoimmune disease are not exclusionary.

Where it is running

• University of Minnesota Cancer Center — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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