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A Phase 1b, Open-label, Dose-escalation Study to Evaluate the Safety and Tolerability of SGN-75 in Combination With Everolimus in Patients With CD70-positive Metastatic Renal Cell Carcinoma


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Renal Cell Carcinoma

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Trial Information

A Phase 1b, Open-label, Dose-escalation Study to Evaluate the Safety and Tolerability of SGN-75 in Combination With Everolimus in Patients With CD70-positive Metastatic Renal Cell Carcinoma


Inclusion Criteria:



- Diagnosis of metastatic renal cell carcinoma with confirmed CD70 expression

- Previously treated with at least 1 tyrosine kinase inhibitor (TKI)

- Measurable disease

- Eastern Cooperative Oncology Group performance status 0 or 1

- Adequate lung and renal function

Exclusion Criteria:

- Prior treatment with anti-CD70-directed therapy

- Prior treatment with an mTOR inhibitor

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence of adverse events and laboratory abnormalities

Outcome Time Frame:

Through 1 month post last dose

Safety Issue:

Yes

Principal Investigator

Nancy Whiting, Pharm D, BCOP

Investigator Role:

Study Director

Investigator Affiliation:

Seattle Genetics, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

SGN75-002

NCT ID:

NCT01677390

Start Date:

August 2012

Completion Date:

April 2015

Related Keywords:

  • Renal Cell Carcinoma
  • Antibody-Drug Conjugate
  • monomethylauristatin F
  • Carcinoma, Renal Cell
  • Antigens, CD70
  • Drug Therapy
  • Carcinoma
  • Carcinoma, Renal Cell

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021
Stanford Cancer CenterStanford, California  94305-5824
Rocky Mountain Cancer Centers - MidtownDenver, Colorado  80218
Karmanos Cancer Institute / Wayne State UniversityDetroit, Michigan  48201
Seattle Cancer Care Alliance / University of WashingtonSeattle, Washington  98109-1023
Miriam Hospital, TheProvidence, Rhode Island  02906