MelanomaPhase 2NCT00093119
Trial of ABI-007 in Previously Treated Patients With Metastatic Melanoma
A Phase 2 study testing ABI-007 in people with Melanoma and Metastases, run by Celgene at 1 site in United States.
Trial summary
This trial will treat patients previously treated for advanced (metastatic) melanoma (skin cancer) with a new chemotherapeutic medicine. The new chemotherapy will be administered weekly in cycles of three weekly doses followed by one week rest. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma, Metastases
- What is being tested?
- ABI-007
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2003to Feb 2005
- 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
- Confirmed Metastatic Melanoma
- At least 18 years old
- No other active malignancy
- Hemoglobin at least 9
- Platelet Count at least 100,000 cells/mm3
- ANC at least 1500 cells/mm3
Show all 14Show fewer
- AST \& ALT less than 2.5X upper limit of normal
- Total bilirubin less than 1.5mg/dL
- Creatine less than 1.5 mg/dL
- Alkaline phosphatase less than 2.5X upper limit of normal
- Life expectancy of at least 12 weeks
- ECOG performance status of 0-1
- Patient must provide informed consent
- Patient must provide authorization to disclose
Who cannot join
- Evidence of active brain metastases
- The only evidence of metastasis is lytic or blastic bone metastases
- Pre-existing peripheral neuropathy of NCI Toxicity Criteria Scale of grade greater than 2
- Received radiotherapy in last 4wks, except if to a non-target lesion only
- Clinically significant concurrent illness
- Investigator's opinion that patient unlikely to complete study
Show all 9Show fewer
- Cytotoxic chemotherapeutic agent treatment or investigational drug within previous 4wks
- History of allergy/hypersensitivity to study drug
- Serious Medical Risk Factors determine by the investigator
Trial locations and contacts
1 site in 1 country.
United States1 site
Abraxis BioScience Inc.
Durham, North Carolina, 27703
About this study
Official title: A Phase II Trial of ABI-007 in Previously Treated Patients With Metastatic Melanoma
This trial will treat patients previously treated for advanced (metastatic) melanoma (skin cancer) with a new chemotherapeutic medicine. The new chemotherapy will be administered weekly in cycles of three weekly doses followed by one week rest. A minimum of three cycles of therapy will be given to determine the anti-tumor response of the new chemotherapy. Patients may continue to stay on therapy a maximum of 9-12 cycles if treatment shows continuing benefit.
- Conditions
- Melanoma, Metastases
- Being tested
- ABI-007
- Keywords
- Metastatic 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.
ABI-007Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine anti-tumor activity of ABI-007 in patients with metastatic melanoma.
Secondary outcomes (1)
Evaluate number of cycles required before patients achieve maximum response
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2004 (estimated)
- Study startJul 2003
- Primary completionFeb 2005
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 CelgeneThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Hawkins, Study director, Celgene Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00093119
- Sponsor's protocol ID
- CA014
- Status last verified
- Apr 2017
- First submitted
- 1 Oct 2004
- Last updated
- 26 Apr 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of ABI-007 in Previously Treated Patients With Metastatic Melanoma
- ClinicalTrials.gov ID
- NCT00093119
- Acronym / sponsor ID
- CA014
- Conditions
- Melanoma, Metastases
- Keywords
- Metastatic Melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- Jul 2003
- Primary completion
- Feb 2005 (actual)
- First posted
- 4 Oct 2004 (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 trial will treat patients previously treated for advanced (metastatic) melanoma (skin cancer) with a new chemotherapeutic medicine. The new chemotherapy will be administered weekly in cycles of three weekly doses followed by one week rest. A minimum of three cycles of therapy will be given to determine the anti-tumor response of the new chemotherapy. Patients may continue to stay on therapy a maximum of 9-12 cycles if treatment shows continuing benefit.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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 (14 listed)
- Confirmed Metastatic Melanoma
- At least 18 years old
- No other active malignancy
- Hemoglobin at least 9
- Platelet Count at least 100,000 cells/mm3
Key exclusion criteria (9 listed)
- Evidence of active brain metastases
- The only evidence of metastasis is lytic or blastic bone metastases
- Pre-existing peripheral neuropathy of NCI Toxicity Criteria Scale of grade greater than 2
- Received radiotherapy in last 4wks, except if to a non-target lesion only
- Clinically significant concurrent illness
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 |
|---|---|---|
| ABI-007 | Drug | – |
Primary outcome
Determine anti-tumor activity of ABI-007 in patients with metastatic melanoma.
1 secondary outcome
Evaluate number of cycles required before patients achieve maximum response
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 26 Apr 2017.
Related trials for Melanoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 1
IL-17 Blockade to Decrease irAEs (REPLAY)
Metastatic Melanoma
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 1
A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy
Melanoma
Active, not recruitingPhase 1/2
A Study of Dapansutrile Plus Pembrolizumab in Patients With PD-1 Refractory Advanced Melanoma
Melanoma
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.
Michael Hawkins study director
Celgene Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ABI-007 in people with Melanoma and Metastases, run by Celgene at 1 site 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 14 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 26 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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?
Determine anti-tumor activity of ABI-007 in patients with metastatic melanoma.. 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 26 Apr 2017.