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Phase I Open-Label Dose Finding Study of SGN-35 for CD30 Positive Hematologic Malignancies

Primary Purpose

Lymphoma, Non-Hodgkin, Disease, Hodgkin, Lymphoma, Large-Cell, Anaplastic

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

SGN-35

About this trial

This is an interventional treatment trial for Lymphoma, Non-Hodgkin focused on measuring Antigens,CD30, Antibody-Drug Conjugate, Antibodies, Monoclonal, Lymphoma, Non-Hodgkin, Disease, Hodgkin, Lymphoma, Large-Cell, Anaplastic, Hematologic Diseases, Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients must have histologically confirmed CD30-positive hematologic malignancy.
Patients with HL must have failed systemic chemotherapy either as induction therapy for advanced stage disease or salvage therapy after initial radiotherapy for early stage disease and were ineligible for, refused treatment by, or previously received stem cell transplant.
Patients must have measurable disease of at least 10mm as documented by radiographic technique.
Must be at least 18 years of age.

Exclusion Criteria:

Patients with current diagnosis of pcALCL (systemic ALCL eligible).
Patients with history of allogeneic stem cell transplant.
Patients who have had previous treatment with any anti-CD30 antibody.

Sites / Locations

University of Alabama at Birmingham
Washington University
Weill Cornell Medical College
University of Texas/MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Incidence of adverse events and laboratory abnormalities

Secondary Outcome Measures

PK profile

Immunogenicity (anti-SGN-35 antibodies)

Anti-tumor activity

Full Information

NCT ID

NCT00430846

First Posted

February 1, 2007

Last Updated

December 17, 2014

Sponsor

Seagen Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00430846

Brief Title

Phase I Open-Label Dose Finding Study of SGN-35 for CD30 Positive Hematologic Malignancies

Official Title

A Phase I Dose Escalation Study of SGN-35 in Patients With Relapsed/Refractory CD30-Positive Hematologic Malignancies.

Study Type

Interventional

2. Study Status

Record Verification Date

December 2014

Overall Recruitment Status

Completed

Study Start Date

November 2006 (undefined)

Primary Completion Date

July 2009 (Actual)

Study Completion Date

July 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Seagen Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Phase I study to define the safety profile and pharmacokinetic parameters of SGN-35 in patients with relapsed/refractory CD30-positive hematologic malignancies. This is a single-arm, open-label, Phase I dose escalation study designed to define the MTD, PK, immunogenicity and anti-tumor activity of SGN-35 in patients with relapsed/refractory CD30-positive hematologic malignancies.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lymphoma, Non-Hodgkin, Disease, Hodgkin, Lymphoma, Large-Cell, Anaplastic

Keywords

Antigens,CD30, Antibody-Drug Conjugate, Antibodies, Monoclonal, Lymphoma, Non-Hodgkin, Disease, Hodgkin, Lymphoma, Large-Cell, Anaplastic, Hematologic Diseases, Lymphoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

45 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

SGN-35

Other Intervention Name(s)

brentuximab vedotin

Intervention Description

Every 21 days. Dose Escalating. 0.1 - 3.6 mg/kg

Primary Outcome Measure Information:

Title

Incidence of adverse events and laboratory abnormalities

Time Frame

1 month after last dose

Secondary Outcome Measure Information:

Title

PK profile

Time Frame

2 months after last dose

Title

Immunogenicity (anti-SGN-35 antibodies)

Time Frame

1 month after last dose

Title

Anti-tumor activity

Time Frame

1 month after last dose

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients must have histologically confirmed CD30-positive hematologic malignancy. Patients with HL must have failed systemic chemotherapy either as induction therapy for advanced stage disease or salvage therapy after initial radiotherapy for early stage disease and were ineligible for, refused treatment by, or previously received stem cell transplant. Patients must have measurable disease of at least 10mm as documented by radiographic technique. Must be at least 18 years of age. Exclusion Criteria: Patients with current diagnosis of pcALCL (systemic ALCL eligible). Patients with history of allogeneic stem cell transplant. Patients who have had previous treatment with any anti-CD30 antibody.

Overall Study Officials: