A Phase 1 Dose-escalation Trial of SGN-75 in CD70-positive Non-Hodgkin Lymphoma or Renal Cell Carcinoma

Lymphoma, Non-Hodgkin Clinical Trial

Official title:

A Phase 1, Open-label, Dose-escalation Study to Evaluate the Safety and Tolerability of SGN-75 in Patients With CD70-positive Relapsed or Refractory Non-Hodgkin Lymphoma or Metastatic Renal Cell Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01015911
• Other study ID #: SGN75-001
• Status: Completed
• Phase: Phase 1
• First received: November 13, 2009
• Last updated: December 17, 2014
• Start date: November 2009
• Est. completion date: March 2012

Study information

• Verified date: December 2014
• Source: Seattle Genetics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This is a phase 1, open-label, dose-escalation clinical trial to evaluate the safety of SGN-75 in patients with CD70-positive relapsed or refractory non-Hodgkin lymphoma or metastatic renal cell carcinoma.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: March 2012
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Pathologically-confirmed diagnosis of NHL or RCC

• Relapsed, refractory, or progressive disease following at least 1 prior systemic therapy

• Confirmed CD70 expression

• Measurable disease, defined as at least 1 lesion >1.5 cm in the greatest transverse diameter for patients with NHL, and at least 1 non-resectable tumor lesion > or equal to 10 mm in diameter for patients with RCC

Exclusion Criteria:

• Previously received an allogeneic transplant

• History of another primary malignancy that has not been in remission for at least 3 years

• Prior anti-CD70-directed therapy

Study Design

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Lymphoma
• Lymphoma, Non-Hodgkin

Intervention

Drug:
• SGN-75
SGN-75 (IV) in 21- or 28-day cycles; dose range: 0.3-9 mg/kg

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Karmanos Cancer Institute / Wayne State University	Detroit	Michigan
United States	City of Hope National Medical Center	Duarte	California
United States	MD Anderson Cancer Center / University of Texas	Houston	Texas
United States	UCLA Medical Center / University of California at Los Angeles	Los Angeles	California
United States	Sarah Cannon Research Institute	Nashville	Tennessee
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Mayo Clinic	Rochester	Minnesota
United States	Seattle Cancer Care Alliance / University of Washington	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Seattle Genetics, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Tannir NM, Forero-Torres A, Ramchandren R, Pal SK, Ansell SM, Infante JR, de Vos S, Hamlin PA, Kim SK, Whiting NC, Gartner EM, Zhao B, Thompson JA. Phase I dose-escalation study of SGN-75 in patients with CD70-positive relapsed/refractory non-Hodgkin lymp — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events and laboratory abnormalities		Through 1 month following last dose	Yes
Secondary	Best clinical response		Every 2 months	No
Secondary	Duration of response, progression-free survival		Every 3 months until progression of disease or initiation of new treatment for cancer	No
Secondary	Blood concentrations of SGN-75 and metabolites		Through 1 month following last dose	No
Secondary	Incidence of antitherapeutic antibodies		Through 1 month following last dose	Yes