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MelanomaPhase 2NCT00492297

A Phase II, Multi-Center, Open-Label, Uncontrolled Study to Evaluate the Efficacy and Safety of Sorafenib Given Daily in Combination With Repeated 21-Day Cycles of Dacarbazine (DTIC) Chemotherapy in Subjects With Advanced Metastatic Melanoma

A Phase 2 study testing Sorafenib (Nexavar, BAY43-9006) + Dacarbazine (DTIC) in people with Melanoma, run by Bayer at 12 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to see whether a new type of anti-cancer drug, known as BAY 43-9006, can be given safely and with good effect in combination with dacarbazine (DTIC). DTIC is the current standard chemotherapy drug given for melanoma that has spread through the body. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Melanoma
What is being tested?
Sorafenib (Nexavar, BAY43-9006) + Dacarbazine (DTIC)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
83 participants
Where
12 sitesin 2 countries
Study dates
Apr 2005to Jul 2008
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Subjects with advanced, metastatic, histologically confirmed melanoma, for whom treatment with dacarbazine is considered medically acceptable
  • Age >= 18 years
  • Subject has measurable and evaluable disease defined as at least one metastatic lesion that can be accurately and serially measured by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) scan as per the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Cutaneous lesions measuring at least 20mm in longest diameter can be considered measurable (and therefore target lesions) via color photography including a ruler
  • Subject has biopsiable disease at baseline and is willing to provide biopsy samples, or does not have biopsiable disease at baseline
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

Who cannot join

  • Primary ocular or mucosal melanoma (cutaneous vulval melanoma is permitted)
  • Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors [Ta, Tis \& T1] or any cancer curatively treated > 3 years prior to study entry
  • (Active coronary artery disease or ischemia (myocardial infarction more than 6 months prior to study entry is allowed)
  • Uncontrolled hypertension (> grade 2 National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 3.0)
  • Active, clinically serious infections (> grade 2 NCI-CTCAE version 3.0)
  • Subjects with seizure disorder requiring medication are excluded
Show all 9Show fewer
  • History of or suspected Human Immunodeficiency Virus (HIV) infection, or chronic hepatitis B or C
  • Symptomatic metastatic brain or meningeal tumors unless the subject is > 6 months from definitive therapy, has a negative imaging study within 4 weeks prior to study entry and is clinically stable with respect to the tumor at the time of study entry. Also the subject must not be undergoing acute steroid therapy or taper (chronic steroid therapy is acceptable provided that the dose is stable for one month prior to and following screening radiographic studies)
  • Pregnant or breast-feeding subjects

Trial locations and contacts

12 sites in 2 countries.

12 sites in 2 countries

United Kingdom8 sites

  • Study site

    Cambridge, Cambridgeshire, CB2 0QQ

  • Study site

    London, London, NW3 2QG

  • Study site

    London, London, SE1 7EH

  • Study site

    London, London, SW3 6JJ

  • Study site

    Manchester, Manchester, M20 4BX

  • Study site

    Northwood, Middlesex, HA6 2RN

  • Study site

    Southampton, Hampshire, SO16 6YD

  • Study site

    Sutton, Surrey, SM2 5PT

Other trials in United Kingdom

France4 sites

  • Study site

    Bordeaux, 33000

  • Study site

    Lyon, 39373

  • Study site

    Toulouse, 31052

  • Study site

    Villejuif, 94805

Other trials in France

About this study

Official title: A Phase II, Multi-center, Open-label, Uncontrolled Study to Evaluate the Efficacy and Safety of BAY 43-9006 Given Daily in Combination With Repeated 21-Day Cycles of Dacarbazine (DTIC) Chemotherapy in Subjects With Advanced Metastatic Melanoma.

The purpose of this study is to see whether a new type of anti-cancer drug, known as BAY 43-9006, can be given safely and with good effect in combination with dacarbazine (DTIC). DTIC is the current standard chemotherapy drug given for melanoma that has spread through the body. Although this drug can be effective on its own and is generally well tolerated, not all patients will benefit, so there is a need to test new drugs and drug combinations for treating melanoma.

Read the detailed description

Issues on "Safety" outcomes are addressed in the Adverse Event section.

Conditions
Melanoma
Being tested
Sorafenib (Nexavar, BAY43-9006) + Dacarbazine (DTIC)
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sorafenib (Nexavar, BAY43-9006) + Dacarbazine (DTIC)Drug

    Dacarbazine 1000 mg/m^2 on day one of repeated 21 day cycles, in combination with daily continuous oral sorafenib (Nexavar, BAY 43-9006), 400 mg twice a day (bid)

Study groups in NCT00492297
Study groupRoleWhat they receive
Sorafenib + DacarbazineExperimentalDacarbazine 1000 mg/m^2 on day one of repeated 21 day cycles, in combination with daily continuous oral sorafenib (Nexavar, BAY 43-9006), 400 mg twice a day (bid)
Receives: Drug: Sorafenib (Nexavar, BAY43-9006) + Dacarbazine (DTIC)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Best Response

    Best Overall Response (BOR): Best tumor response achieved during or within 30 days after active therapy confirmed according to the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR): The disappearance of all target and non-target lesions. Partial response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. SD was defined as steady state of disease, PD was defined as an increase of at least 20% increase in the sum of the LD of target lesions or appearance of new lesions.

    Measured: during or within 30 days after active therapy

Secondary outcomes (10)

  1. Progression-free Survival

    Progression-free Survival (PFS) was the time from the first dose of combination therapy to disease progression (radiological or clinical, whichever is earlier) or death (if death occurs before progression is documented). PFS for subjects without tumor progression or death at the time of analysis were censored at the date of last tumor evaluation.

    Measured: from start of treatment until progression or death before progression (median 259 days)

  2. Percentage of Subjects With Progression-free Survival at Specific Time-points

    Progression-free Survival (PFS) was the time from the first dose of combination therapy to disease progression (radiological or clinical, whichever is earlier) or death (if death occurs before progression is documented). PFS for subjects without tumor progression or death at the time of analysis were censored at the date of last tumor evaluation.

    Measured: from start of treatment until progression or death before progression after 3, 6 and 12 months

  3. Overall Survival

    Overall Survival was the number of days from the date that combination treatment started until the date of death.

    Measured: from start of treatment until death (median 259 days)

  4. Duration of Response

    Duration of Response was assessed in subjects who showed a Partial Response (PR) or Complete Response (CR). It was defined as the time from the first documented objective response to Progressive Disease (PD), or death if before documented progression. Duration of response for subjects who have not progressed or died at the time of analysis was censored at the date of last tumor assessment.

    Measured: from confirmed Complete Response (CR) or Partial Response (PR) until Progressive Disease (PD) (median 259 days)

  5. Duration of Complete Response

    Duration of complete response was the number of days from the date that a complete response was first documented to the date that recurrent or progressive disease was first objectively documented (if patient progressed then censored=no) or to last observation (if patient did not progress then censored=yes).

    Measured: from confirmed CR until PD (median 259 days)

  6. Duration of Partial Response

    Duration of partial response was the number of days from the date that a partial response was first documented to the date that recurrent or progressive disease was first objectively documented (if patient progressed then censored=no) or to last observation (if patient did not progress then censored=yes).

    Measured: from confirmed PR until PD (median 259 days)

  7. Disease Control (DC)

    DC was defined as the total number of subjects whose best response was not progressive disease (PD) (total number of CRs + total number of PRs + total number of Stable Diseases (SD)). The DC at specific time points could also be calculated as the total number of subjects whose response was not PD at that time point.

    Measured: after start of treatment, at 6 months and 12 months

  8. Duration of Stable Disease

    Duration of Stable Disease (DSD), defined as the time from the first documented objective evidence of Stable Disease (SD) to disease progression (DP) or death if death occurred before DP, was assessed in subjects who showed SD as best response. DSD for subjects who had not progressed or died was censored at the date of last tumor assessment.

    Measured: from start of therapy to PD, only in non-responders (median 259 days)

  9. Time to Response

    Time to Response in subjects who achieved an objective response (PR or CR with confirmation) was measured from the date of starting study combination treatment until the earliest date that the response was first documented.

    Measured: start of therapy to confirmed CR or PR (median 259 days)

  10. Time to Progression

    Time to Progression was the number of days from the start of therapy to progression (if patient progressed then censored=no) or to the last observation at which the patient was known to have not progressed, that is, the last observation with a best response of CR, PR, or SD.

    Measured: From start of treatment until progression (median 259 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2007 (estimated)
  2. Study startApr 2005
  3. Primary completionJun 2008
  4. Study completionJul 2008

Resources

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
83 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00492297
Sponsor's protocol ID
11538
Other IDs
2004-000725-30, 2004
Status last verified
Oct 2014
First submitted
26 Jun 2007
Last updated
31 Oct 2014
Data monitoring committee
No

Publications

  • Eisen T, Marais R, Affolter A, Lorigan P, Robert C, Corrie P, Ottensmeier C, Chevreau C, Chao D, Nathan PD, Jouary T, Harries M, Negrier S, Montegriffo E, Ahmad T, Gibbens I, James MG, Strauss UP, Prendergast S, Gore ME. Sorafenib and dacarbazine as first-line therapy for advanced melanoma: phase I and open-label phase II studies. Br J Cancer. 2011 Jul 26;105(3):353-9. doi: 10.1038/bjc.2011.257. Epub 2011 Jul 12.

    PubMed 21750549

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sorafenib (Nexavar, BAY43-9006) + Dacarbazine (DTIC) in people with Melanoma, run by Bayer at 12 sites in 2 countries.

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 5 inclusion and 9 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 31 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United Kingdom, France. 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?

Yes. Results are posted in the registry (first posted 25 Jan 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Best Response (time frame: during or within 30 days after active therapy). 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 NCT00492297, 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 31 Oct 2014; AzTrials last refreshed its copy on 29 Oct 2026.

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