CompletedPhase 2

Phase II Study of Afinitor vs. Sutent in Patients With Metastatic Non-Clear Cell Renal Cell Carcinoma

United States131 participantsStarted 2010-09

Plain-language summary

To compare the anti-tumor activity of everolimus and sunitinib in subjects with metastatic renal cell carcinoma (mRCC) with non-clear cell pathology.

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Histologically confirmed advanced Renal Cell Carcinoma (RCC), with non-clear cell pathology.
✓. RCC tumor tissue available for correlative sciences, from either primary or metastatic site or both.
✓. At the time of screening, at least 4 weeks since prior palliative radiation therapy and/or major surgery, and resolution of all toxic effects of prior therapy to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE; version 4.0) Grade 1.
✓. Subject must have radiographic evidence of metastatic disease with at least 1 measurable per RECIST 1.1 criteria (Attachment 1)\].
✓. Age \> 18 years.
✓. Adequate laboratory values
✓. Karnofsky Performance Status ≥ 60 (Attachment 2).
✓. Life expectancy of at least 3 months.

✕. Subjects with a history of or active central nervous system (CNS) metastases.
✕. Prior systemic therapy for RCC, including mTOR and anti-angiogenic therapy, chemotherapy, biologic or experimental therapy.
✕. Subjects with collecting duct, medullary, small cell, oncocytoma, or lymphoma-type pathology.
✕. Subjects receiving known strong CYP3A4 isoenzyme inhibitors and/or inducers.
✕. Major surgery, open biopsy, traumatic injury, or radiotherapy within 4 weeks of the screening visit.
✕. Subjects who have not recovered from prior biopsy, surgery, traumatic injury, and/or radiation therapy.
✕. Presence of a non-healing wound or ulcer.
✕. Grade 3 hemorrhage within the past month.

Anti-tumor Activity as Measured by Median Progression Free Survival Time

Timeframe: 24 Months

NCT IDNCT01108445

SponsorDuke University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-02

Results submitted2016-02-16

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Histologically confirmed advanced Renal Cell Carcinoma (RCC), with non-clear cell pathology.
✓. RCC tumor tissue available for correlative sciences, from either primary or metastatic site or both.
✓. At the time of screening, at least 4 weeks since prior palliative radiation therapy and/or major surgery, and resolution of all toxic effects of prior therapy to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE; version 4.0) Grade 1.
✓. Subject must have radiographic evidence of metastatic disease with at least 1 measurable per RECIST 1.1 criteria (Attachment 1)\].
✓. Age \> 18 years.
✓. Adequate laboratory values
✓. Karnofsky Performance Status ≥ 60 (Attachment 2).
✓. Life expectancy of at least 3 months.

✕. Subjects with a history of or active central nervous system (CNS) metastases.
✕. Prior systemic therapy for RCC, including mTOR and anti-angiogenic therapy, chemotherapy, biologic or experimental therapy.
✕. Subjects with collecting duct, medullary, small cell, oncocytoma, or lymphoma-type pathology.
✕. Subjects receiving known strong CYP3A4 isoenzyme inhibitors and/or inducers.
✕. Major surgery, open biopsy, traumatic injury, or radiotherapy within 4 weeks of the screening visit.
✕. Subjects who have not recovered from prior biopsy, surgery, traumatic injury, and/or radiation therapy.
✕. Presence of a non-healing wound or ulcer.
✕. Grade 3 hemorrhage within the past month.