NEXT: Subsequent Exposure to Tyrosine Kinase Inhibition at Recurrence After Adjuvant Therapy in Renal Cell Carcinoma

Stopped early · Phase 2

Conditions studied: Renal Cell Carcinoma

In brief

The purpose of this study is to see how well the study drug, axitinib, helps control renal (kidney) cancer that has come back (recurrent) or spread (metastatic). Patients must have already been treated as a participant in a clinical trial with sunitinib, sorafenib, pazopanib or placebo (sugar pill) after their initial surgery. This study will examine the effect of adjuvant tyrosine kinase inhibition (TKI) therapy (sorafenib, sunitinib or pazopanib) on subsequent exposure to TKI with axitinib in the first-line recurrent or metastatic setting.

Key facts

Study ID

NCT01649180

Run by

PrECOG, LLC.

People needed

3

Starts

2012-07-01

Expected to finish

2016-03-01

Last updated by the study team

2021-08-12

Who can join

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

You may qualify if…

• Locally recurrent or metastatic RCC requiring systemic therapy following treatment (tx) with sorafenib, sunitinib, pazopanib, or placebo on an adjuvant study
• Required to have primary or recurrence tumor samples containing clear cell variant RCC with <50% of any other histology
• Recurrence must occur ≥ 3 months following end of exposure to the adjuvant intervention
• Received ≥ 3 six week cycles of prior adjuvant tx with sorafenib, sunitinib, pazopanib or placebo in the adjuvant setting on a clinical trial, or recurrence >3 months of tx on an adjuvant placebo arm
• Required to have measurable recurrent or metastatic disease that is not curable by standard radiation therapy or surgery
• Male or female, ≥ 18 years old
• ECOG PS 0 or 1
• Blood pressure (B/P) must be controlled at time of enrollment. Tx with antihypertensive medication(s) is allowed. Controlled B/P is defined as in clinic measurement of systolic B/P ≤ 140 mm Hg AND diastolic B/P ≤ 90 mm Hg. If B/P is uncontrolled at time of planned enrollment, tx or optimization with antihypertensive medication(s) may be initiated in order to control B/P. Patient may be considered for enrollment when this has happened.
• Women must not be pregnant or breastfeeding
• Men and women who are of reproductive potential must be willing to employ an effective method of birth control/contraception
• Willingness and ability to comply with scheduled visits, tx plans, laboratory tests, and other study procedures
• Ability to understand and willingness to sign an IRB-approved informed consent
• Adequate organ function as evidenced by the following, obtained within 28 days prior to registration:
• Absolute neutrophil count (ANC) ≥ 1250 cells/mm³
• Platelet count ≥ 75,000 cells/mm³
• Hemoglobin ≥ 9.0 g/dL
• Total direct serum bilirubin ≤ 1.5x upper limit of normal (ULN)
• ALT and AST ≤ 2.5 x ULN unless there are liver metastases in which case AST and ALT ≤ 5.0 x ULN
• Serum creatinine <1.5 x ULN or calculated creatinine clearance ≥ 45 mL/min
• Urine protein <2+ by urine dipstick
• Resolution of all previous tx-related toxicity to ≤ grade 1 or back to baseline
• No major surgery <4 weeks or radiation therapy <2 weeks of starting study tx. Prior palliative radiotherapy to metastatic lesion(s) is permitted, provided there is at least one measurable lesion that has not been irradiated.
• No clinically significant gastrointestinal abnormalities
• No current use or anticipated need for tx with drugs that are known potent CYP3A4 inhibitors
• No current or anticipated need for tx with drugs that are known CYP3A4 or CYP1A2 inducers

Where it is running

• Missouri Valley Cancer Consortium — Omaha, Nebraska, United States
• Cleveland Clinic, Taussig Cancer Institute — Cleveland, Ohio, United States
• University of Pennsylvania, Abramson Cancer Center — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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