Soft Tissue SarcomaPhase 2SAHA-INCT00918489
Study on Efficacy and Tolerability of Vorinostat in Patients With Advanced, Metastatic Soft Tissue Sarcoma (STS)
A Phase 2 study testing Vorinostat in people with Soft Tissue Sarcoma, run by Heidelberg University at 7 sites in Germany.
Trial summary
Primary objective of the study is to investigate the efficacy of vorinostat in patients suffering from selected histological types of soft tissue sarcoma. Further evaluations relate to the safety and tolerability of vorinostat, its pharmacokinetics (course of plasma concentration over time) and pharmacodynamics (mode… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Soft Tissue Sarcoma
- What is being tested?
- Vorinostat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 7 sitesGermany
- Study dates
- May 2010to Sep 2013
- Phase
- Phase 2
- 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
- Patients with verified, metastatic soft tissue sarcoma of the following histologies:
- undifferentiated highgrade pleomorphic sarcoma/pleomorphic malignant fibrous histiocytoma,
- undifferentiated pleomorphic sarcoma with grand cells/grand cell fibrotic histiocytoma,
- undifferentiated pleomorphic sarcoma with prominent inflammation/inflamed MFH,
- myxofibrosarcoma,
- liposarcoma,
Show all 33Show fewer
- synovial sarcoma,
- rhabdomyosarcoma (pleomorph, alveolar und embryonal),
- leiomyosarcoma,
- adult fibrosarcoma,
- angiosarcoma,
- malignant hemangiopericytoma/ malignant solitaire fibrous tumor,
- malignant peripheral neurilemma tumor,
- extraskeletal mesenchymal chondrosarcoma,
- extraskeletal myxoid chondrosarcoma,
- undifferentiated sarcoma of non other specified (NOS) type.
- Verified relapse or disease progression at study inclusion, i.e. therapeutic failure of the first line therapy with anthracyclines,
- Measurable disease according to the RECIST criteria,
- Previous systemic therapy of advanced and/or metastatic disease,
- An interval of at least 4 weeks since the last surgery, chemotherapy or radiation,
- Age over 18,
- Following laboratory findings:
- ANC ≥ 1.0 x 10³/mm³,
- platelets ≥ 100.000/mm³,
- hemoglobin ≥ 9 g/dl,
- creatinin < 1.5 x ULN (upper limit of normal),
- AST and ALT < 2.5 x ULN,
- total bilirubin < 1.5 x ULN,
- Life expectancy of at least 12 weeks,
- Negative pregnancy test,
- Consent for an effective contraception during and up to 6 month after the study completion.
- Written informed consent,
- Ability to understand the goal and the consequences of this trial.
Who cannot join
- Proof of the following histologies:
- gastrointestinal stromal tumor (GIST),
- malignant mesothelioma,
- neuroblastoma,
- osteosarcoma,
- Ewing's sarcoma/PNET,
Show all 15Show fewer
- Concurrent radio- or chemotherapy,
- Participation in another interventional trial within 4 weeks prior to the inclusion,
- Previous therapy with another HDAC-inhibitor (e.g. depsipeptide, MS-275, LAQ-824, PXD-101 und valproic acid). Patients, who underwent a therapy with valproic acid for treatment of seizures, can be included after a wash-out period of at least 30 days,
- Symptomatic brain metastases, that have not been treated by radiotherapy. The interval between the last radiation and the study inclusion must not be shorter than 30 days,
- Previous malignant disease (except for a non-melanoma of the skin and a carcinoma in situ of uterus), unless in complete remission and after the last therapy for at least 5 years,
- Ejection fraction < 40 %,
- Nursing,
- Known allergy against the IMP or drugs with similar chemical structure or additives,
- Active hepatitis B and/or C and HIV-infection
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Germany7 sites
Department of Oncology, Hematology and Palliative Medicine, Marien Hospital Düsseldorf
Düsseldorf, North Rhine-Westphalia, D-40479
Department of Hematology, Hemostaseology, Oncology and Stemm Cell Transplantation, Medical School Hannover
Hanover, Niedersachen, D-30625
Comprehensive Cancer Center North, University Hospital Kiel
Kiel, 24105
Sarcoma Center Mannheim, University Hospital Mannheim
Mannheim, 68167
Department of Hematology, Oncology, Rheumatology and Immunology, University Hospital Tübingen
Tübingen, Baden-Wurttemberg, D-72076
Center for Soft Tissue Sarcoma, University Hospital Tübingen
Tübingen, 72074
Comprehensive Cancer Center Ulm (CCCU)
Ulm, 89081
About this study
Official title: A Phase II Study to Investigate the Efficacy and Tolerability of Vorinostat in Patients Suffering From Advanced, Metastatic Soft Tissue Sarcoma
Primary objective of the study is to investigate the efficacy of vorinostat in patients suffering from selected histological types of soft tissue sarcoma. Further evaluations relate to the safety and tolerability of vorinostat, its pharmacokinetics (course of plasma concentration over time) and pharmacodynamics (mode of action). Only subjects with advanced, metastatic disease will be included in this trail.
Read the detailed description
The treatment with vorinostat will be administered daily over 28 days. This period will be referred to as a therapy cycle. Two consecutive therapy cycles will be separated by a 7-days therapy break. In case of a good response and no relevant side effects, the treatment with vorinostat can be continued for up to 1 year after begin of the treatment. If any relevant side effects or intolerability occur, the dose and/or schedule of administration will be modified according to the pre-defined criteria.
- Conditions
- Soft Tissue Sarcoma
- Being tested
- Vorinostat
- Keywords
- soft tissue sarcoma, metastatic, vorinostat
- Medical subject headings
- Sarcoma, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VorinostatDrug
Daily administration of 400mg vorinostat on 28 days (one therapy cycle). Seven days of therapy break between two consecutive cycles.
| Study group | Role | What they receive |
|---|---|---|
| Vorinostat | Experimental | Daily administration of 400mg vorinostat on 28 days (one therapy cycle). Seven days of therapy break between two consecutive cycles. Receives: Drug: Vorinostat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the efficacy of vorinostat on the basis of progression free survival (PFS) up to 1 year after first administration of the IMP.
Measured: Up to 1 year
Secondary outcomes (1)
Evaluation of the efficacy of vorinostat on the basis of overall survival up to 1 year after first administration of the IMP. Investigation on pharmacokinetics und pharmacodynamics of vorinostat. Evaluation of safety and tolerability of vorinostat.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2009 (estimated)
- Study startMay 2010
- Primary completionSep 2013
- Study completionSep 2013
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 Soft Tissue SarcomaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Gerlinde Egerer, Heidelberg University
- Investigators
- Gerlinde Egerer, MD, Study director, Department of Internal Medicine V, Universtity Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00918489
- Sponsor's protocol ID
- SAHA-I
- Acronym
- SAHA-I
- Status last verified
- Oct 2018
- First submitted
- 10 Jun 2009
- Last updated
- 17 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Schmitt T, Mayer-Steinacker R, Mayer F, Grunwald V, Schutte J, Hartmann JT, Kasper B, Husing J, Hajda J, Ottawa G, Mechtersheimer G, Mikus G, Burhenne J, Lehmann L, Heilig CE, Ho AD, Egerer G. Vorinostat in refractory soft tissue sarcomas - Results of a multi-centre phase II trial of the German Soft Tissue Sarcoma and Bone Tumour Working Group (AIO). Eur J Cancer. 2016 Sep;64:74-82. doi: 10.1016/j.ejca.2016.05.018. Epub 2016 Jun 28.
PubMed 27367154
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study to Investigate the Efficacy and Tolerability of Vorinostat in Patients Suffering From Advanced, Metastatic Soft Tissue Sarcoma
- ClinicalTrials.gov ID
- NCT00918489
- Acronym / sponsor ID
- SAHA-I / SAHA-I
- Conditions
- Soft Tissue Sarcoma
- Keywords
- soft tissue sarcoma, metastatic, vorinostat
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- May 2010
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 11 Jun 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.
Primary objective of the study is to investigate the efficacy of vorinostat in patients suffering from selected histological types of soft tissue sarcoma. Further evaluations relate to the safety and tolerability of vorinostat, its pharmacokinetics (course of plasma concentration over time) and pharmacodynamics (mode of action). Only subjects with advanced, metastatic disease will be included in this trail.
Detailed description
The treatment with vorinostat will be administered daily over 28 days. This period will be referred to as a therapy cycle. Two consecutive therapy cycles will be separated by a 7-days therapy break. In case of a good response and no relevant side effects, the treatment with vorinostat can be continued for up to 1 year after begin of the treatment. If any relevant side effects or intolerability occur, the dose and/or schedule of administration will be modified according to the pre-defined criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vorinostat | Experimental | Drug: VorinostatDaily administration of 400mg vorinostat on 28 days (one therapy cycle). Seven days of therapy break between two consecutive cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (33 listed)
- Patients with verified, metastatic soft tissue sarcoma of the following histologies:
- Verified relapse or disease progression at study inclusion, i.e. therapeutic failure of the first line therapy with anthracyclines,
- Measurable disease according to the RECIST criteria,
- Previous systemic therapy of advanced and/or metastatic disease,
- An interval of at least 4 weeks since the last surgery, chemotherapy or radiation,
Key exclusion criteria (15 listed)
- Proof of the following histologies:
- Concurrent radio- or chemotherapy,
- Participation in another interventional trial within 4 weeks prior to the inclusion,
- Previous therapy with another HDAC-inhibitor (e.g. depsipeptide, MS-275, LAQ-824, PXD-101 und valproic acid). Patients, who underwent a therapy with valproic acid for treatment of seizures, can be included after a wash-out period of at least 30 days,
- Symptomatic brain metastases, that have not been treated by radiotherapy. The interval between the last radiation and the study inclusion must not be shorter than 30 days,
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 |
|---|---|---|
| VorinostatDaily administration of 400mg vorinostat on 28 days (one therapy cycle). Seven days of therapy break between two consecutive cycles. | Drug | Vorinostat |
Primary outcome
Evaluation of the efficacy of vorinostat on the basis of progression free survival (PFS) up to 1 year after first administration of the IMP.
Time frame: Up to 1 year
1 secondary outcome
Evaluation of the efficacy of vorinostat on the basis of overall survival up to 1 year after first administration of the IMP. Investigation on pharmacokinetics und pharmacodynamics of vorinostat. Evaluation of safety and tolerability of vorinostat.
Time frame: Up to 1 year
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 17 Oct 2018.
- Derived from this study: PubMed 27367154Schmitt T, Mayer-Steinacker R, Mayer F, Grunwald V, Schutte J, Hartmann JT, Kasper B, Husing J, Hajda J, Ottawa G, Mechtersheimer G, Mikus G, Burhenne J, Lehmann L, Heilig CE, Ho AD, Egerer G. Vorinostat in refractory soft tissue sarcomas - Results of a multi-centre phase II trial of the German Soft Tissue Sarcoma and Bone Tumour Working Group (AIO). Eur J Cancer. 2016 Sep;64:74-82. doi: 10.1016/j.ejca.2016.05.018. Epub 2016 Jun 28.
Related trials for Soft Tissue Sarcoma
RecruitingPhase 2
A Multicenter Phase II Clinical Trial Evaluating 68Ga-HX01 Injection for PET/CT Imaging
Soft Tissue Sarcoma
RecruitingPhase 3
Measuring if Immunotherapy Plus Chemotherapy is Better Than Chemotherapy Alone for Patients With Aggressive Poorly Differentiated Sarcomas
Metastatic Dedifferentiated Liposarcoma, Metastatic Undifferentiated Pleomorphic Sarcoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 1/2
Dose Escalation and Dose Expansion Study of MDX2003 in Patients With Different Types of Lymphoma
Lymphoma, Waldenström Macroglobulinemia (WM)
Enrolling by invitationPhase 1
Evaluation of the I-phase Clinical Trial of 177Lu-HX02 Injection in Patients With Advanced Malignant Solid Tumors
Soft Tissue Sarcoma, Non-small Cell Lung Cancer
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.
Gerlinde Egerer, MD study director
Department of Internal Medicine V, Universtity Hospital Heidelberg
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vorinostat in people with Soft Tissue Sarcoma, run by Heidelberg University at 7 sites in Germany.
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 33 inclusion and 15 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 17 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Germany. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Evaluation of the efficacy of vorinostat on the basis of progression free survival (PFS) up to 1 year after first administration of the IMP. (time frame: Up to 1 year). 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 NCT00918489, 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 17 Oct 2018.