Disease, HodgkinPhase 1NCT00649584
A Phase I Dose Escalation Study of SGN-35 Alone and in Combination With Gemcitabine for CD30-Positive Malignancies
A Phase 1 study testing SGN-35 and gemcitabine in people with Disease, Hodgkin and Lymphoma, Large-Cell, Anaplastic, run by Seagen Inc. at 5 sites in United States.
Trial summary
This study will examine the safety profile of SGN-35 alone and in combination with gemcitabine. The study will test increasing doses of SGN-35 given weekly to small groups of patients. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Disease, Hodgkin, Lymphoma, Large-Cell, Anaplastic, Lymphoma, Non-Hodgkin
- What is being tested?
- SGN-35 and gemcitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 5 sitesUnited States
- Study dates
- Mar 2008to Feb 2010
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Histologically confirmed CD30-positive hematologic malignancy.
- Patients with HL must have failed systemic chemotherapy.
- Patients with other CD30-positive malignancies (including ALCL) must be beyond first remission or refractory to front line chemotherapy.
- Patients must have measurable disease of at least 1.5 cm as documented by radiographic technique.
Who cannot join
- Current diagnosis of primary cutaneous ALCL (systemic ALCL eligible).
- History of allogeneic stem cell transplant.
- Patients who have had previous treatment with any anti-CD30 antibody.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35294-3300
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030-4003
University of Miami
Miami, Florida, 33136
Stanford University Medical Center
Palo Alto, California, 94305
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: A Phase I Dose Escalation Study of Weekly SGN-35 Monotherapy and in Combination With Gemcitabine in Patients With Relapsed/Refractory CD30-positive Hematologic Malignancies
This study will examine the safety profile of SGN-35 alone and in combination with gemcitabine. The study will test increasing doses of SGN-35 given weekly to small groups of patients.
- Being tested
- SGN-35, gemcitabine
- Keywords
- Antigens, CD30, Antibody-Drug Conjugate, Antibodies, Monoclonal, monomethyl auristatin E, Combined Modality Therapy, Drug Therapy, Immunotherapy, Lymphoma, Non-Hodgkin, Disease, Hodgkin, Lymphoma, Large-Cell, Anaplastic, Hematologic Diseases, Lymphoma
- Medical subject headings
- Hodgkin Disease, Lymphoma, Large-Cell, Anaplastic, Lymphoma, Non-Hodgkin, Hematologic Diseases, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SGN-35Drug
Also called brentuximab vedotin
IV; 0.4 up to 1.8 mg/kg weekly 3 out of 4 weeks; minimum of two 28-day cycles
gemcitabineDrug
Also called Gemzar
IV; 1000 mg/m2 weekly 3 out of 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | SGN-35 alone or in combination with gemcitabine Receives: Drug: SGN-35; Drug: gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events and laboratory abnormalities
Measured: 1 month after last dose
Secondary outcomes (3)
PK profile
Measured: 2 months after last dose
Immunogenicity (anti-SGN-35 antibodies)
Measured: 1 month after last dose
Anti-tumor activity
Measured: 1 month after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2008 (estimated)
- Study startMar 2008
- Primary completionFeb 2010
- Study completionFeb 2010
Why it stopped: Sponsor decision not to enroll cohorts of combined SGN-35 and gemcitabine therapy.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Disease, HodgkinStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seagen Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dana Kennedy, PharmD, Study director, Seagen Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00649584
- Sponsor's protocol ID
- SG035-0002
- Status last verified
- Dec 2014
- First submitted
- 27 Mar 2008
- Last updated
- 18 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Fanale MA, Forero-Torres A, Rosenblatt JD, Advani RH, Franklin AR, Kennedy DA, Han TH, Sievers EL, Bartlett NL. A phase I weekly dosing study of brentuximab vedotin in patients with relapsed/refractory CD30-positive hematologic malignancies. Clin Cancer Res. 2012 Jan 1;18(1):248-55. doi: 10.1158/1078-0432.CCR-11-1425. Epub 2011 Nov 11.
PubMed 22080439
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
- A Phase I Dose Escalation Study of Weekly SGN-35 Monotherapy and in Combination With Gemcitabine in Patients With Relapsed/Refractory CD30-positive Hematologic Malignancies
- ClinicalTrials.gov ID
- NCT00649584
- Acronym / sponsor ID
- SG035-0002
- Keywords
- Antigens, CD30, Antibody-Drug Conjugate, Antibodies, Monoclonal, monomethyl auristatin E, Combined Modality Therapy, Drug Therapy, Immunotherapy, Lymphoma, Non-Hodgkin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision not to enroll cohorts of combined SGN-35 and gemcitabine therapy.
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Seagen Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 1 Apr 2008 (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.
This study will examine the safety profile of SGN-35 alone and in combination with gemcitabine. The study will test increasing doses of SGN-35 given weekly to small groups of patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: SGN-35, Drug: gemcitabineSGN-35 alone or in combination with gemcitabine |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically confirmed CD30-positive hematologic malignancy.
- Patients with HL must have failed systemic chemotherapy.
- Patients with other CD30-positive malignancies (including ALCL) must be beyond first remission or refractory to front line chemotherapy.
- Patients must have measurable disease of at least 1.5 cm as documented by radiographic technique.
Key exclusion criteria (3 listed)
- Current diagnosis of primary cutaneous ALCL (systemic ALCL eligible).
- History of allogeneic stem cell transplant.
- Patients who have had previous treatment with any anti-CD30 antibody.
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 |
|---|---|---|
| SGN-35Also: brentuximab vedotinIV; 0.4 up to 1.8 mg/kg weekly 3 out of 4 weeks; minimum of two 28-day cycles | Drug | 1 |
| gemcitabineAlso: GemzarIV; 1000 mg/m2 weekly 3 out of 4 weeks | Drug | 1 |
Primary outcome
Incidence of adverse events and laboratory abnormalities
Time frame: 1 month after last dose
3 secondary outcomes
PK profile
Time frame: 2 months after last dose
Immunogenicity (anti-SGN-35 antibodies)
Time frame: 1 month after last dose
Anti-tumor activity
Time frame: 1 month after last dose
Results and safety
The study was stopped early (reason given: Sponsor decision not to enroll cohorts of combined SGN-35 and gemcitabine therapy.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2014.
- Results publication: PubMed 22080439Fanale MA, Forero-Torres A, Rosenblatt JD, Advani RH, Franklin AR, Kennedy DA, Han TH, Sievers EL, Bartlett NL. A phase I weekly dosing study of brentuximab vedotin in patients with relapsed/refractory CD30-positive hematologic malignancies. Clin Cancer Res. 2012 Jan 1;18(1):248-55. doi: 10.1158/1078-0432.CCR-11-1425. Epub 2011 Nov 11.
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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.
Dana Kennedy, PharmD study director
Seagen Inc.
5 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 SGN-35 and gemcitabine in people with Disease, Hodgkin and Lymphoma, Large-Cell, Anaplastic, run by Seagen Inc. at 5 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 4 inclusion and 3 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: stopped early, 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 5 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 was stopped early (reason given: Sponsor decision not to enroll cohorts of combined SGN-35 and gemcitabine therapy.). Results are not available in the source record.
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?
Incidence of adverse events and laboratory abnormalities (time frame: 1 month after last dose). 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 NCT00649584, which also lists 1 linked publication.
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.