CarcinomasPhase 1NCT01026415
Clinical Pharmacology Study of Brentuximab Vedotin (SGN-35)
A Phase 1 study testing brentuximab vedotin, rifampin and midazolam in people with Carcinomas and Disease, Hodgkin, run by Seagen Inc. at 6 sites in United States.
Trial summary
The purpose of this study is to identify brentuximab vedotin drug-drug interactions in patients with CD30-positive cancers and to determine the main route of excretion. The study will also assess blood drug levels in patients with renal or hepatic impairment (special populations). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinomas, Disease, Hodgkin, Lymphoma, Large-Cell, Anaplastic
- What is being tested?
- brentuximab vedotin, rifampin and midazolam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 6 sitesUnited States
- Study dates
- Dec 2009to May 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adequate organ function (Special Populations: serum bilirubin >2 mg/dL or creatinine clearance <50 mL/min)
- ECOG performance status <2 (Special Populations: <4)
- Relapsed or refractory CD30-positive malignancy
Who cannot join
- Receiving prohibited medication within 4 weeks
- Poor liver function (Child-Pugh class C)
- Current diagnosis of primary cutaneous ALCL
- Acute or chronic graft-versus-host disease
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Colorado Blood Cancer Institute
Denver, Colorado, 80218
Karmanos Cancer Institute / Wayne State University
Detroit, Michigan, 48209
City of Hope
Duarte, California, 91010
Hackensack University Medical Center
Hackensack, New Jersey, 07601
St. Francis Medical Group Oncology & Hematology Specialists
Indianapolis, Indiana, 46237
Seattle Cancer Care Alliance / University of Washington Medical Center
Seattle, Washington, 98109-1023
About this study
Official title: An Open-Label Clinical Pharmacology Study of Brentuximab Vedotin (SGN-35) in Patients With CD30-Positive Hematologic Malignancies: CYP3A4 Drug-Drug Interactions, Excretion, and Special Populations
The purpose of this study is to identify brentuximab vedotin drug-drug interactions in patients with CD30-positive cancers and to determine the main route of excretion. The study will also assess blood drug levels in patients with renal or hepatic impairment (special populations).
- Conditions
- Carcinomas, Disease, Hodgkin, Lymphoma, Large-Cell, Anaplastic, Lymphoma, Non-Hodgkin, Neoplasms
- Keywords
- Antibody-Drug Conjugate, Antigens, CD30, Disease, Hodgkin, Lymphoma, Large-Cell, Anaplastic, Lymphoma, Non-Hodgkin, monomethyl auristatin E, Drug Therapy, Immunotherapy, Hematologic Diseases, Lymphoma, Antibodies, Monoclonal
- Medical subject headings
- Carcinoma, Hodgkin Disease, Lymphoma, Large-Cell, Anaplastic, Lymphoma, Non-Hodgkin, Neoplasms, Hematologic Diseases, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
brentuximab vedotinDrug
Also called ADCETRIS; SGN-35
1.8 mg/kg IV every 21 days
rifampinDrug
600 mg/day PO
midazolamDrug
1 mg IV
ketoconazoleDrug
400 mg/day PO
brentuximab vedotinDrug
Also called SGN-35
1.2 mg/kg IV every 21 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | midazolam +/- brentuximab vedotin Receives: Drug: brentuximab vedotin; Drug: midazolam |
| 2 | Experimental | brentuximab vedotin +/- rifampin Receives: Drug: brentuximab vedotin; Drug: rifampin |
| 3 | Experimental | brentuximab vedotin +/- ketoconazole Receives: Drug: ketoconazole; Drug: brentuximab vedotin |
| 4 | Experimental | special populations Receives: Drug: brentuximab vedotin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Midazolam blood concentrations +/- brentuximab vedotin
Measured: 3 weeks
Brentuximab vedotin blood concentrations +/- rifampin
Measured: 6 weeks
Brentuximab vedotin in urine, feces, and blood
Measured: 1 week
Brentuximab vedotin blood concentrations in special populations
Measured: 3 weeks
Brentuximab vedotin blood concentrations +/- ketoconazole
Measured: 6 weeks
Secondary outcomes (1)
Incidence of adverse events and laboratory abnormalities
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CarcinomasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seagen Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Millennium Pharmaceuticals, Inc.
- Responsible party
- Sponsor
- Investigators
- Thomas Manley, MD, Study director, Seagen Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01026415
- Sponsor's protocol ID
- SGN35-008
- Status last verified
- Dec 2014
- First submitted
- 2 Dec 2009
- Last updated
- 18 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
- Expanded access
- Available
Publications
Han TH, Gopal AK, Ramchandren R, Goy A, Chen R, Matous JV, Cooper M, Grove LE, Alley SC, Lynch CM, O'Connor OA. CYP3A-mediated drug-drug interaction potential and excretion of brentuximab vedotin, an antibody-drug conjugate, in patients with CD30-positive hematologic malignancies. J Clin Pharmacol. 2013 Aug;53(8):866-77. doi: 10.1002/jcph.116. Epub 2013 Jun 10.
PubMed 23754575Gopal AK, Ramchandren R, O'Connor OA, Berryman RB, Advani RH, Chen R, Smith SE, Cooper M, Rothe A, Matous JV, Grove LE, Zain J. Safety and efficacy of brentuximab vedotin for Hodgkin lymphoma recurring after allogeneic stem cell transplantation. Blood. 2012 Jul 19;120(3):560-8. doi: 10.1182/blood-2011-12-397893. Epub 2012 Apr 17.
PubMed 22510871
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Clinical Pharmacology Study of Brentuximab Vedotin (SGN-35) in Patients With CD30-Positive Hematologic Malignancies: CYP3A4 Drug-Drug Interactions, Excretion, and Special Populations
- ClinicalTrials.gov ID
- NCT01026415
- Acronym / sponsor ID
- SGN35-008
- Conditions
- Carcinomas, Disease, Hodgkin, Lymphoma, Large-Cell, Anaplastic, Lymphoma, Non-Hodgkin, Neoplasms
- Keywords
- Antibody-Drug Conjugate, Antigens, CD30, Disease, Hodgkin, Lymphoma, Large-Cell, Anaplastic, Lymphoma, Non-Hodgkin, monomethyl auristatin E, Drug Therapy, Immunotherapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Seagen Inc.Industry (pharma, biotech, devices)
- Collaborators
- Millennium Pharmaceuticals, Inc.
- Study start
- Dec 2009
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 4 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to identify brentuximab vedotin drug-drug interactions in patients with CD30-positive cancers and to determine the main route of excretion. The study will also assess blood drug levels in patients with renal or hepatic impairment (special populations).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: brentuximab vedotin, Drug: midazolammidazolam +/- brentuximab vedotin |
| 2 | Experimental | Drug: brentuximab vedotin, Drug: rifampinbrentuximab vedotin +/- rifampin |
| 3 | Experimental | Drug: ketoconazole, Drug: brentuximab vedotinbrentuximab vedotin +/- ketoconazole |
| 4 | Experimental | Drug: brentuximab vedotinspecial populations |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adequate organ function (Special Populations: serum bilirubin >2 mg/dL or creatinine clearance <50 mL/min)
- ECOG performance status <2 (Special Populations: <4)
- Relapsed or refractory CD30-positive malignancy
Key exclusion criteria (4 listed)
- Receiving prohibited medication within 4 weeks
- Poor liver function (Child-Pugh class C)
- Current diagnosis of primary cutaneous ALCL
- Acute or chronic graft-versus-host disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| brentuximab vedotinAlso: ADCETRIS; SGN-351.8 mg/kg IV every 21 days | Drug | 1, 2 |
| rifampin600 mg/day PO | Drug | 2 |
| midazolam1 mg IV | Drug | 1 |
| ketoconazole400 mg/day PO | Drug | 3 |
| brentuximab vedotinAlso: SGN-351.2 mg/kg IV every 21 days | Drug | 3, 4 |
Primary outcome
Midazolam blood concentrations +/- brentuximab vedotin
Time frame: 3 weeks
Brentuximab vedotin blood concentrations +/- rifampin
Time frame: 6 weeks
Brentuximab vedotin in urine, feces, and blood
Time frame: 1 week
Brentuximab vedotin blood concentrations in special populations
Time frame: 3 weeks
Brentuximab vedotin blood concentrations +/- ketoconazole
Time frame: 6 weeks
1 secondary outcome
Incidence of adverse events and laboratory abnormalities
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2014.
- Results publication: PubMed 23754575Han TH, Gopal AK, Ramchandren R, Goy A, Chen R, Matous JV, Cooper M, Grove LE, Alley SC, Lynch CM, O'Connor OA. CYP3A-mediated drug-drug interaction potential and excretion of brentuximab vedotin, an antibody-drug conjugate, in patients with CD30-positive hematologic malignancies. J Clin Pharmacol. 2013 Aug;53(8):866-77. doi: 10.1002/jcph.116. Epub 2013 Jun 10.
- Derived from this study: PubMed 22510871Gopal AK, Ramchandren R, O'Connor OA, Berryman RB, Advani RH, Chen R, Smith SE, Cooper M, Rothe A, Matous JV, Grove LE, Zain J. Safety and efficacy of brentuximab vedotin for Hodgkin lymphoma recurring after allogeneic stem cell transplantation. Blood. 2012 Jul 19;120(3):560-8. doi: 10.1182/blood-2011-12-397893. Epub 2012 Apr 17.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Manley, MD study director
Seagen Inc.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing brentuximab vedotin, rifampin and midazolam in people with Carcinomas and Disease, Hodgkin, run by Seagen Inc. at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Midazolam blood concentrations +/- brentuximab vedotin (time frame: 3 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01026415, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2014.