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

Sponsor

Seagen Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT01015911

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

6.4

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Carcinoma, Renal Cell Lymphoma, Non-Hodgkin	Drug: SGN-75	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

58 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Nov 1, 2009

Actual Primary Completion Date :

Nov 1, 2011

Actual Study Completion Date :

Mar 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 SGN-75	Drug: SGN-75 SGN-75 (IV) in 21- or 28-day cycles; dose range: 0.3-9 mg/kg

Arm

Intervention/Treatment

Experimental: 1

SGN-75

Drug: SGN-75

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

Outcome Measures

Primary Outcome Measures

Incidence of adverse events and laboratory abnormalities [Through 1 month following last dose]

Secondary Outcome Measures

Best clinical response [Every 2 months]
Duration of response, progression-free survival [Every 3 months until progression of disease or initiation of new treatment for cancer]
Blood concentrations of SGN-75 and metabolites [Through 1 month following last dose]
Incidence of antitherapeutic antibodies [Through 1 month following last dose]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35294-3300
2	City of Hope National Medical Center	Duarte	California	United States	91010-3000
3	UCLA Medical Center / University of California at Los Angeles	Los Angeles	California	United States	90095-1678
4	Karmanos Cancer Institute / Wayne State University	Detroit	Michigan	United States	48201
5	Mayo Clinic	Rochester	Minnesota	United States	55905
6	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10021
7	Sarah Cannon Research Institute	Nashville	Tennessee	United States	37203
8	MD Anderson Cancer Center / University of Texas	Houston	Texas	United States	77030
9	Seattle Cancer Care Alliance / University of Washington	Seattle	Washington	United States	98109-1023