Malignant MelanomaPhase 2NCT00232726
Clinical Study of Previously Untreated Patients With Malignant Melanoma
A Phase 2 study testing CP-4055 (ELACYT) in people with Malignant Melanoma and Neoplasm Metastasis, run by Clavis Pharma at 3 sites in 3 countries.
Trial summary
Previously untreated patients with malignant melanoma receive a new chemotherapy drug currently under development. CP-4055 is given intravenously on days 1-5 every four weeks until complete response or disease progression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Melanoma, Neoplasm Metastasis
- What is being tested?
- CP-4055 (ELACYT)
- How many people
- 42 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Sep 2005to Jul 2007
- 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 histologically or cytologically confirmed stage IV or unresectable stage III non-ocular malignant melanoma who have not undergone prior chemotherapy for the treatment of melanoma (chemotherapy-naïve)
- Measurable disease according to Response Criteria in Solid Tumours (RECIST)
- Performance Status 0 - 2 according to ECOG (Eastern Cooperative Oncology Group) Performance Status
- Age 18 years or more
- Life expectancy > 3 months
- Signed informed consent
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- Adequate haematological and biological functions:
- Bone marrow function:
- Neutrophils ≥ 1.5 x 10^9/L
- Platelets ≥ 100 x 10^9/L
- Hemoglobin (Hb) ≥ 10 g/dL
- Hepatic function:
- AST/ALT ≤ 2.5 times institutional upper limit of normal (ULN). If liver metastases, ≤ 5 times institutional ULN.
- Serum bilirubin and alkaline phosphatase ≤ 1.5 times institutional ULN
- Renal function:
- Creatinine ≤ 1.5 times institutional ULN
Who cannot join
- Known brain metastases
- Diagnosis of ocular malignant melanoma
- Radiotherapy to more than 30% of bone marrow
- Participation in another therapeutic clinical study within 30 days of enrolment or during this clinical study
- Prior immunotherapy and/or chemotherapy for the treatment of melanoma
- Requirement of concomitant treatment with a non-permitted medication:
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- Alternative drugs
- High doses of vitamins
- History of allergic reactions to Ara-C or egg
- Presence of any serious concomitant systemic disorders incompatible with the clinical study (e.g. uncontrolled intercurrent illness including ongoing or active infection)
- Presence of any significant central nervous system or psychiatric disorder(s) that would hamper the patient's compliance
- Pregnancy, breastfeeding, or absence of adequate contraception for both male and female fertile patients
- Known positive status for HIV and/or hepatitis B or C
- Drug and/or alcohol abuse
- Any reason why, in the Investigator's opinion, the patient should not participate
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213-2584
About this study
Official title: A Non-Randomised, Multicentre, Phase II Clinical Study of CP-4055 in Chemotherapy-Naïve Patients With Metastatic Malignant Melanoma
Previously untreated patients with malignant melanoma receive a new chemotherapy drug currently under development. CP-4055 is given intravenously on days 1-5 every four weeks until complete response or disease progression.
Read the detailed description
This is an international multicentre phase II clinical study conducted in the USA and Europe. Previously untreated patients over 18 years, with metastatic malignant melanoma are eligible for inclusion if they fulfil all inclusion- and exclusion criteria. 16 or 42 patients will be enrolled in Pittsburgh USA, Lund Sweden and Oslo Norway.
The new development drug CP-4055 is administered for five consecutive days (Day 1 to 5) in a 4 week schedule (one cycle). The dose is 200 mg/m2/day.
A patient will continue treatment until complete response or until (s)he is withdrawn from the Clinical Study because of disease progression, unacceptable toxicity or any other reason described in the clinical study protocol.
Efficacy is assessed at baseline and end of every second cycle with CT or MRI.
Safety assessments are done at each visit. Blood samples are taken and haematological and biochemical parameters are assessed for safety.
Any adverse events are recorded and reported.
The clinical study has been approved by the relevant Independent Ethical Committees/Institutional Review Boards and Concerned Regulatory Authority as appropriate. It is conducted according to ICH Good Clinical Practice, the Declaration of Helsinki, and applicable national law and regulations.
Patients who give an additional consent will have two additional, and not mandatory, procedures performed:
- Biopsy (tissue sample) from particular tumours (taken only at baseline for identification of tumour genes)
- Serum samples (from blood drawn at baseline and at end of the cycle 2 for protein sequences analyses, proteomics)
- Conditions
- Malignant Melanoma, Neoplasm Metastasis
- Being tested
- CP-4055 (ELACYT)
- Keywords
- Malignant melanoma, CP-4055, Chemotherapy-naïve patients, Phase II, Chemotherapy-naive patients, Metastatic malignant melanoma
- Medical subject headings
- Melanoma, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CP-4055 (ELACYT)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective tumour response
Secondary outcomes (3)
Time to progression
Duration of tumour response
Safety and tolerability of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2005 (estimated)
- Study startSep 2005
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant MelanomaStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clavis Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Svein Dueland, MD, Ph.D, Principal investigator, The Norwegian Radium Hospital, Montebello, NO-0310 Oslo, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00232726
- Sponsor's protocol ID
- CP4055-201
- Status last verified
- Jul 2007
- First submitted
- 4 Oct 2005
- Last updated
- 10 Jul 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-Randomised, Multicentre, Phase II Clinical Study of CP-4055 in Chemotherapy-Naïve Patients With Metastatic Malignant Melanoma
- ClinicalTrials.gov ID
- NCT00232726
- Acronym / sponsor ID
- CP4055-201
- Conditions
- Malignant Melanoma, Neoplasm Metastasis
- Keywords
- Malignant melanoma, CP-4055, Chemotherapy-naïve patients, Phase II, Chemotherapy-naive patients, Metastatic malignant melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Clavis PharmaIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- Study completion
- Jul 2007 (actual)
- First posted
- 5 Oct 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.
Previously untreated patients with malignant melanoma receive a new chemotherapy drug currently under development. CP-4055 is given intravenously on days 1-5 every four weeks until complete response or disease progression.
Detailed description
This is an international multicentre phase II clinical study conducted in the USA and Europe. Previously untreated patients over 18 years, with metastatic malignant melanoma are eligible for inclusion if they fulfil all inclusion- and exclusion criteria. 16 or 42 patients will be enrolled in Pittsburgh USA, Lund Sweden and Oslo Norway.
The new development drug CP-4055 is administered for five consecutive days (Day 1 to 5) in a 4 week schedule (one cycle). The dose is 200 mg/m2/day.
A patient will continue treatment until complete response or until (s)he is withdrawn from the Clinical Study because of disease progression, unacceptable toxicity or any other reason described in the clinical study protocol.
Efficacy is assessed at baseline and end of every second cycle with CT or MRI.
Safety assessments are done at each visit. Blood samples are taken and haematological and biochemical parameters are assessed for safety.
Any adverse events are recorded and reported.
The clinical study has been approved by the relevant Independent Ethical Committees/Institutional Review Boards and Concerned Regulatory Authority as appropriate. It is conducted according to ICH Good Clinical Practice, the Declaration of Helsinki, and applicable national law and regulations.
Patients who give an additional consent will have two additional, and not mandatory, procedures performed:
- Biopsy (tissue sample) from particular tumours (taken only at baseline for identification of tumour genes)
- Serum samples (from blood drawn at baseline and at end of the cycle 2 for protein sequences analyses, proteomics)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Patients with histologically or cytologically confirmed stage IV or unresectable stage III non-ocular malignant melanoma who have not undergone prior chemotherapy for the treatment of melanoma (chemotherapy-naïve)
- Measurable disease according to Response Criteria in Solid Tumours (RECIST)
- Performance Status 0 - 2 according to ECOG (Eastern Cooperative Oncology Group) Performance Status
- Age 18 years or more
- Life expectancy > 3 months
Key exclusion criteria (15 listed)
- Known brain metastases
- Diagnosis of ocular malignant melanoma
- Radiotherapy to more than 30% of bone marrow
- Participation in another therapeutic clinical study within 30 days of enrolment or during this clinical study
- Prior immunotherapy and/or chemotherapy for the treatment of melanoma
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 |
|---|---|---|
| CP-4055 (ELACYT) | Drug | – |
Primary outcome
Objective tumour response
3 secondary outcomes
Time to progression
Duration of tumour response
Safety and tolerability of treatment
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 10 Jul 2007.
- Sponsor's home pageLink 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.
Svein Dueland, MD, Ph.D principal investigator
The Norwegian Radium Hospital, Montebello, NO-0310 Oslo, Norway
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CP-4055 (ELACYT) in people with Malignant Melanoma and Neoplasm Metastasis, run by Clavis Pharma at 3 sites in 3 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 16 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 10 Jul 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Norway, Sweden. 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?
Objective tumour response. 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 10 Jul 2007.