Brentuximab Vedotin in Patients With CD30-positive Nonlymphomatous Malignancies
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01461538 |
|
Recruitment Status :
Completed
First Posted : October 28, 2011
Results First Posted : March 4, 2016
Last Update Posted : March 4, 2016
|
Sponsor:
Seagen Inc.
Information provided by (Responsible Party):
Seagen Inc.
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Brief Summary:
This is an open-label, multicenter, phase 2 clinical trial to evaluate the antitumor activity of brentuximab vedotin as a single agent in patients with CD30-positive nonlymphomatous malignancies.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Acute Lymphoid Leukemia Acute Myeloid Leukemia Anemia, Refractory, With Excess of Blasts Solid Tumors | Drug: brentuximab vedotin | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 84 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 2, Open-label Study of Brentuximab Vedotin in Patients With CD30-positive Nonlymphomatous Malignancies |
| Study Start Date : | October 2011 |
| Actual Primary Completion Date : | December 2014 |
| Actual Study Completion Date : | December 2014 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Familial acute myeloid leukemia with mutated CEBPA
Cytogenetically normal acute myeloid leukemia
Core binding factor acute myeloid leukemia
Drug Information available for:
Brentuximab vedotin
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Brentuximab vedotin 1.8 mg/kg
Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
|
Drug: brentuximab vedotin
1.8 mg/kg every 3 weeks by intravenous (IV) infusion
Other Name: Adcetris; SGN-35 |
|
Experimental: Brentuximab vedotin 2.4 mg/kg
Brentuximab vedotin 2.4 mg/kg every 3 weeks by IV infusion
|
Drug: brentuximab vedotin
2.4 mg/kg every 3 weeks by intravenous (IV) infusion
Other Name: Adcetris; SGN-35 |
|
Experimental: Brentuximab vedotin 1.2 mg/kg
Brentuximab vedotin 1.2 mg/kg weekly, 3 out of 4 weeks, by IV infusion
|
Drug: brentuximab vedotin
1.2 mg/kg weekly, 3 out of 4 weeks, by intravenous (IV) infusion
Other Name: Adcetris; SGN-35 |
Primary Outcome Measures :
- Objective Response Rate (ORR) by Investigator [ Time Frame: Up to approximately 3 years ]Percentage of participants who achieved a best response of complete response/remission (CR), CR without hematologic recovery (CRi; leukemia only), or partial remission (PR) per the applicable response criteria. Response criteria for solid tumors (by radiographic tumor imaging) per Response Evaluation Criteria for Solid Tumors (RECIST) 1.1 (Eisenhauer 2009); response criteria for leukemia (by peripheral blood and bone marrow aspirate or biopsy) per International Working Group (Cheson 2003).
Secondary Outcome Measures :
- Complete Remission (CR) Rate by Investigator [ Time Frame: Up to approximately 3 years ]Percentage of participants who achieved a best response of CR per the applicable response criteria. Response criteria for solid tumors (by radiographic tumor imaging) per Response Evaluation Criteria for Solid Tumors (RECIST) 1.1 (Eisenhauer 2009); response criteria for leukemia (by peripheral blood and bone marrow aspirate or biopsy) per International Working Group (Cheson 2003).
- Duration of Objective Response by Kaplan-Meier Analysis [ Time Frame: Up to approximately 2 years ]Duration of objective response (CR [+CRi; leukemia] + PR), defined as time of initial response until disease progression or death. Response criteria for solid tumors (by radiographic tumor imaging) per Response Evaluation Criteria for Solid Tumors (RECIST) 1.1 (Eisenhauer 2009); response criteria for leukemia (by peripheral blood and bone marrow aspirate or biopsy) per International Working Group (Cheson 2003).
- Duration of Complete Response by Kaplan-Meier Analysis [ Time Frame: Up to approximately 2 years ]Duration of CR, defined as time of initial response until disease progression or death. Response criteria for solid tumors (by radiographic tumor imaging) per Response Evaluation Criteria for Solid Tumors (RECIST) 1.1 (Eisenhauer 2009); response criteria for leukemia (by peripheral blood and bone marrow aspirate or biopsy) per International Working Group (Cheson 2003).
- Progression-Free Survival by Kaplan-Meier Analysis [ Time Frame: Up to approximately 2 years ]Progression-free survival, defined as time from start of study treatment to disease progression per investigator or death due to any cause
- Adverse Events by Severity, Seriousness, and Relationship to Treatment [ Time Frame: Up to approximately 3 years ]Counts of participants who had treatment-emergent adverse events (TEAE, defined as newly occurring or worsening after first dose on Study SGN35-013). Serious adverse events are reported from the time of informed consent. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 4.03) were used to assess severity (1=mild, 2=moderate, 3=severe, 4=life-threatening/disabling, 5=fatal). Relatedness to study drug was assessed by the investigator (Yes/No). Participants with multiple occurrences of an adverse event within a category are counted once within the category.
- Laboratory Abnormalities >/= Grade 3 [ Time Frame: Up to approximately 3 years ]Counts of study participants with post-baseline laboratory abnormalities of Grade 3 or greater per NCI CTCAE version 4.03. Participants with multiple occurrences of a laboratory abnormality within a category are counted once in that category
- Brentuximab Vedotin Antibody-Drug Conjugate (ADC) Concentration at End of Infusion (Ceoi) [ Time Frame: Up to approximately 3 years ]
- Brentuximab Vedotin Antibody-Drug Conjugate (ADC) Trough Concentration (Ctrough) [ Time Frame: Up to approximately 3 years ]
- Maximum Concentration (Cmax) of Brentuximab Vedotin Monomethyl Auristatin E (MMAE) [ Time Frame: Up to approximately 3 years ]
- Brentuximab Vedotin Monomethyl Auristatin E (MMAE) Trough Concentration (Ctrough) [ Time Frame: Up to approximately 3 years ]
- Incidence of Anti-therapeutic Antibodies (ATA) [ Time Frame: Up to approximately 3 years ]Counts of participants with post-baseline anti-brentuximab vedotin antibodies. Persistently positive is defined as confirmed ATA in more than 2 post-baseline samples and transiently positive is defined as confirmed ATA in 1 or 2 post-baseline samples.
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 6 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histologically-confirmed by central review CD30-positive nonlymphomatous malignancy
- Have failed, refused, or have been deemed ineligible for standard therapy
- Measurable disease
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1 or a Karnofsky or Lansky Performance Status score greater than or equal to 70
Exclusion Criteria:
- Primary diagnosis of lymphoma or central nervous system (CNS) malignancy
- History of another primary invasive malignancy that has not been definitively treated or in remission for at least 3 years
- Evidence of active cerebral/meningeal disease
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01461538
Locations
Show 29 study locations
Sponsors and Collaborators
Seagen Inc.
Investigators
| Study Director: | Neil Josephson, MD | Seagen Inc. |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Seagen Inc. |
| ClinicalTrials.gov Identifier: | NCT01461538 |
| Other Study ID Numbers: |
SGN35-013 |
| First Posted: | October 28, 2011 Key Record Dates |
| Results First Posted: | March 4, 2016 |
| Last Update Posted: | March 4, 2016 |
| Last Verified: | February 2016 |
Keywords provided by Seagen Inc.:
|
Acute Lymphoid Leukemia Myelodysplastic Syndrome Acute Myeloid Leukemia Solid Tumors Anemia, Refractory, with Excess of Blasts Antibodies, Monoclonal |
Antibody-Drug Conjugate Antigens, CD30 Drug Therapy Hematologic Diseases Immunotherapy Monomethyl Auristatin E |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Myeloid, Acute Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Anemia, Refractory Anemia, Refractory, with Excess of Blasts Neoplasms by Histologic Type Neoplasms Leukemia, Myeloid Anemia |
Hematologic Diseases Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Myelodysplastic Syndromes Bone Marrow Diseases Antibodies, Monoclonal Immunologic Factors Physiological Effects of Drugs |