MelanomaPhase 2NCT00185302
Safety and Efficacy Study of a New Chemotherapy Agent to Treat Metastatic Melanoma
A Phase 2 study testing Histone Deacetylase Inhibitor, MS-275 (BAY 86-5274, ZK 244894) in people with Melanoma, run by Bayer.
Trial summary
Primary objective: To evaluate the efficacy of two different dosing schedules of MS-275 in subjects with metastatic melanoma Secondary objectives: To evaluate the safety and to assess the pharmacokinetic profile of MS-275 in subjects with metastatic melanoma Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- Histone Deacetylase Inhibitor, MS-275 (BAY 86-5274, ZK 244894)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- Dec 2004to Jul 2006
- 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
- Adult subjects with Stage III or IV non-resectable nonuveal (cutaneous or mucosal) metastatic melanoma who had received at least one but no more than two previous systemic therapies (immunotherapy and/or chemotherapy) for metastatic disease and who had not responded to or who had progressed after their most recent therapy were eligible for enrollment
- Presence of at least one lesion fulfilling the minimum Response Evaluation Criteria in Solid Tumors (RECIST) size requirements for a target lesion - Use of highly effective birth control methods in females of child-bearing potential
- Able to undergo either contrast enhanced computed tomography (CT) scan or contrast enhanced magnetic resonance imaging (MRI) scan for tumor assessment
- Life expectancy greater than 3 months
- Adequate organ and bone marrow functions as defined below: absolute neutrophil count ≥ 1500 /µL, platelets ≥ 100,000 /µL, creatinine ≤ 1.5 × upper limit of normal (ULN) or measured creatinine clearance of ≥ 60 mL/min x 1.73 m2 body surface area, total bilirubin ≤ 1.5 times ULN, aspartate aminotransferase or serum glutamic oxalacetic transaminase/alanine aminotransferase or serum glutamic pyruvic transaminase∗ ≤ 2.5 times ULN
- Negative serum pregnancy test within 2 weeks prior to receiving the first dose of study drug in female subjects of childbearing potential. Agreement to use a highly effective method of birth control throughout the study period and 3 months thereafter for sexually active males and females of childbearing potentia
Who cannot join
- Active malignancy in the last five years
- Pregnancy, breast feeding
- HIV infection
- Brain metastasis
- Concomitant use of corticosteroids or valproic acid
- Uncontrolled intercurrent illness
Show all 16Show fewer
- Diagnosis of uveal melanoma
- Eastern Cooperative Oncology Group performance status ≥ 2
- Ongoing effects from previous investigational drug studies or concomitant participation in other investigational drug studies
- Prior use of MS-275 or any other HDAC inhibitor
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to MS-275
- Anticancer therapy
- Active gastrointestinal conditions that might predispose for poor drug absorption
- Major surgery within 4 weeks prior to enrollment
- Hypophosphatemia < 2.5 mg/dL at screening, if not corrected in the screening period
- Medical, psychiatric or other conditions that compromise the patient's ability to understand the patient information, to give informed consent, to comply with the trial protocol, or to complete the study
About this study
Official title: Phase II Study of MS-275, a Histone Deacetylase Inhibitor, Comparing 2 Dosage Schedules in Patients With Metastatic Melanoma
Primary objective: To evaluate the efficacy of two different dosing schedules of MS-275 in subjects with metastatic melanoma Secondary objectives: To evaluate the safety and to assess the pharmacokinetic profile of MS-275 in subjects with metastatic melanoma
Read the detailed description
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.
- Conditions
- Melanoma
- Being tested
- Histone Deacetylase Inhibitor, MS-275 (BAY 86-5274, ZK 244894)
- Keywords
- Non-resectable metastatic melanoma
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Histone Deacetylase Inhibitor, MS-275 (BAY 86-5274, ZK 244894)Drug
MS-275, 3 mg on Days 1 and 15 of a 4-week cycle
Histone Deacetylase Inhibitor, MS-275 (BAY 86-5274, ZK 244894)Drug
MS-275, 7 mg on Days 1, 8 and 15 of a 4-week cycle
| Study group | Role | What they receive |
|---|---|---|
| Histone Deacetylase Inhibitor, 3 mg | Experimental | Subjects received 3 mg MS-275 orally biweekly (Days 1 and 15 of a 4 week cycle) or until disease progression or unacceptable toxicity Receives: Drug: Histone Deacetylase Inhibitor, MS-275 (BAY 86-5274, ZK 244894) |
| Histone Deacetylase Inhibitor, 7 mg | Experimental | Subjects received 7 mg MS-275 orally weekly (Days 1, 8, and 15 of a 4 week cycle) until disease progression or unacceptable toxicity Receives: Drug: Histone Deacetylase Inhibitor, MS-275 (BAY 86-5274, ZK 244894) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall tumor response rate (the proportion of subjects with the best tumor response of PR or CR within the first 6 cycles of treatment)
Measured: Baseline, 8, 16, 24, 32 weeks (cycle 6)
Secondary outcomes (5)
Time to tumor progression
Measured: Baseline, every 8 weeks until progression
Survival
Measured: At 6 months
Tumor response rate at each tumor assessment time point (CR/PR/SD/PD/not assessable)
Measured: At baseline and repeated every 2 cycles until tumor progression between Day 22 of even numbered cycles and Day 1 of subsequent odd numbered cycle and also at EOT and F-up visiit (90 days after the EOT and every 3 months until disease progression)
Time to death
Measured: Baseline, every 8 weeks until death
Number of participants with adverse events
Measured: Approximately 8-64 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startDec 2004
- Primary completionJul 2006
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00185302
- Sponsor's protocol ID
- 91410
- Other IDs
- 2004-002395-41, 309100, 2004
- Status last verified
- Dec 2015
- First submitted
- 12 Sep 2005
- Last updated
- 14 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of MS-275, a Histone Deacetylase Inhibitor, Comparing 2 Dosage Schedules in Patients With Metastatic Melanoma
- ClinicalTrials.gov ID
- NCT00185302
- Acronym / sponsor ID
- 91410
- Conditions
- Melanoma
- Keywords
- Non-resectable metastatic melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Dec 2004
- Primary completion
- Jul 2006 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 16 Sep 2005 (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: To evaluate the efficacy of two different dosing schedules of MS-275 in subjects with metastatic melanoma Secondary objectives: To evaluate the safety and to assess the pharmacokinetic profile of MS-275 in subjects with metastatic melanoma
Detailed description
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Histone Deacetylase Inhibitor, 3 mg | Experimental | Drug: Histone Deacetylase Inhibitor, MS-275 (BAY 86-5274, ZK 244894)Subjects received 3 mg MS-275 orally biweekly (Days 1 and 15 of a 4 week cycle) or until disease progression or unacceptable toxicity |
| Histone Deacetylase Inhibitor, 7 mg | Experimental | Drug: Histone Deacetylase Inhibitor, MS-275 (BAY 86-5274, ZK 244894)Subjects received 7 mg MS-275 orally weekly (Days 1, 8, and 15 of a 4 week cycle) until disease progression or unacceptable toxicity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult subjects with Stage III or IV non-resectable nonuveal (cutaneous or mucosal) metastatic melanoma who had received at least one but no more than two previous systemic therapies (immunotherapy and/or chemotherapy) for metastatic disease and who had not responded to or who had progressed after their most recent therapy were eligible for enrollment
- Presence of at least one lesion fulfilling the minimum Response Evaluation Criteria in Solid Tumors (RECIST) size requirements for a target lesion - Use of highly effective birth control methods in females of child-bearing potential
- Able to undergo either contrast enhanced computed tomography (CT) scan or contrast enhanced magnetic resonance imaging (MRI) scan for tumor assessment
- Life expectancy greater than 3 months
- Adequate organ and bone marrow functions as defined below: absolute neutrophil count ≥ 1500 /µL, platelets ≥ 100,000 /µL, creatinine ≤ 1.5 × upper limit of normal (ULN) or measured creatinine clearance of ≥ 60 mL/min x 1.73 m2 body surface area, total bilirubin ≤ 1.5 times ULN, aspartate aminotransferase or serum glutamic oxalacetic transaminase/alanine aminotransferase or serum glutamic pyruvic transaminase∗ ≤ 2.5 times ULN
Key exclusion criteria (16 listed)
- Active malignancy in the last five years
- Pregnancy, breast feeding
- HIV infection
- Brain metastasis
- Concomitant use of corticosteroids or valproic acid
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 |
|---|---|---|
| Histone Deacetylase Inhibitor, MS-275 (BAY 86-5274, ZK 244894)MS-275, 3 mg on Days 1 and 15 of a 4-week cycle | Drug | Histone Deacetylase Inhibitor, 3 mg |
| Histone Deacetylase Inhibitor, MS-275 (BAY 86-5274, ZK 244894)MS-275, 7 mg on Days 1, 8 and 15 of a 4-week cycle | Drug | Histone Deacetylase Inhibitor, 7 mg |
Primary outcome
Overall tumor response rate (the proportion of subjects with the best tumor response of PR or CR within the first 6 cycles of treatment)
Time frame: Baseline, 8, 16, 24, 32 weeks (cycle 6)
5 secondary outcomes
Time to tumor progression
Time frame: Baseline, every 8 weeks until progression
Survival
Time frame: At 6 months
Tumor response rate at each tumor assessment time point (CR/PR/SD/PD/not assessable)
Time frame: At baseline and repeated every 2 cycles until tumor progression between Day 22 of even numbered cycles and Day 1 of subsequent odd numbered cycle and also at EOT and F-up visiit (90 days after the EOT and every 3 months until disease progression)
Time to death
Time frame: Baseline, every 8 weeks until death
Number of participants with adverse events
Time frame: Approximately 8-64 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 14 Dec 2015.
- Click here to find information about studies related to Bayer Healthcare products conducted in Europe.Link provided by the sponsor.
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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.
Bayer Study Director study director
Bayer
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Histone Deacetylase Inhibitor, MS-275 (BAY 86-5274, ZK 244894) in people with Melanoma, run by Bayer.
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 6 inclusion and 16 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 14 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Overall tumor response rate (the proportion of subjects with the best tumor response of PR or CR within the first 6 cycles of treatment) (time frame: Baseline, 8, 16, 24, 32 weeks (cycle 6)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Dec 2015.