MelanomaPhase 1/2NCT00084214
STA-4783/Paclitaxel or Paclitaxel Alone in Melanoma
A Phase 1/2 study testing STA-4783 and Paclitaxel in people with Melanoma, run by Synta Pharmaceuticals Corp. at 28 sites in United States.
Trial summary
This study is designed to assess the efficacy of a weekly treatment regimen of STA-4783 and paclitaxel in comparison to paclitaxel alone on tumor response in metastatic melanoma patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- STA-4783 and Paclitaxel
- How many people
- 103 participants
- Where
- 28 sitesUnited States
- Study dates
- May 2004to not given
- Phase
- Phase 1/2
- 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
- M or F 18 or older with histologically confirmed metastatic (Stage IV) melanoma of cutaneous origin
- ECOG performance status of greater than or equal to 2
- Measurable disease per RECIST criteria
- Received no more than 1 regimen of prior chemotherapy (unlimited immunotherapy regimens are allowed)
- At least 4 weeks have passed since last chemotherapy or immunotherapy
- At least 2 weeks have passed since last radiotherapy.
- Life expectancy of greater than 12 weeks
- Clinical lab values within protocol parameters
Who cannot join
- Female patients pregnant or lactating
- Female patients of childbearing potential not using or not willing to use effective contraception
- Presence of a second malignancy other than nonmelanoma skin cancer
- Presence of a clinically significant and uncontrolled infection
- Presence of clinically significant arrythmias
- Presence of serious concurrent illness or other conditions that do not permit adequate follow-up and compliance with protocol
- History of severe hypersensitivity reactions to taxanes
- Use of any investigational agents within 4 weeks prior to the first dose of study drug
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
United States28 sites
Emory University - Winship Cancer Institute
Atlanta, Georgia, 30322-1013
Anschutz Cancer Pavillion - Univ Of Colorado
Aurora, Colorado, 80010
Odyssey Research and St. Alexius Medical Center
Bismarck, North Dakota, 58501
Cancer Care Center Of Southern Indiana
Bloomington, Indiana, 47403
Piedmont Oncology Specialists
Charlotte, North Carolina, 28207
Ellis Fischels Cancer Center - Univ Of Missouri
Columbia, Missouri, 65203
Danville Hematology & Oncology, Inc.
Danville, Virginia, 24541-4155
Center For Cancer Care At Goshen Health
Goshen, Indiana, 46527-0139
Research Institute Hawaii Pacific Health
Honolulu, Hawaii, 96813
Genesis Cancer Center
Hot Springs, Arkansas, 71913
Indiana Oncology Hematology Consultants
Iindianapolis, Indiana, 46202
Joliet Oncology-Hematology Associates, Ltd.
Joliet, Illinois, 60435
Univ Of Arkansas/Arkansas Research Center
Little Rock, Arkansas, 72205-7101
James Graham Brown Cancer Center - University Of Louisville
Louisville, Kentucky, 40202
University of Wisconsin Medical School
Madison, Wisconsin, 53792-0001
Cancer Care Center
New Albany, Indiana, 47150-6809
Oncology Specialists
Park Ridge, Illinois, 60068
Providence Cancer Center
Portland, Oregon, 97213-2933
Office of James Stark, MD
Portsmouth, Virginia, 23707
Virginia Cancer Institute
Richmond, Virginia, 23230
Hubert H. Humphrey Cancer Center
Robbinsdale, Minnesota, 55422
Scripps Cancer Center
San Diego, California, 92121
Northern California Melanoma Center
San Francisco, California, 94109
Cancer Institute Medical Group, Inc
Santa Monica, California, 90404
Maine Center for Cancer Medicine & Blood Disorders
Scarborough, Maine, 04074
Mountainside Hospital, Suburban Surgical Associates
St Louis, Missouri, 63131
Hematology Oncology P.C.
Stamford, Connecticut, 06902-3628
Medical Oncology and Hematology, P.C.
Waterbury, Connecticut, 06708
About this study
Official title: A Two-Stage Trial of STA-4783 in Combination With Weekly Paclitaxel for Treatment of Patients With Metastatic Melanoma
This study is designed to assess the efficacy of a weekly treatment regimen of STA-4783 and paclitaxel in comparison to paclitaxel alone on tumor response in metastatic melanoma patients.
Read the detailed description
STA-4783 is a taxane potentiator, enhancing the effect of antitumor response of paclitaxel. In an attempt to improve efficacy, paclitaxel is sometimes used in combination with other anticancer agents. When paclitaxel is combined with other anticancer agents, although response rate is usually increased, side effects are usually increased as well. There is an urgent need for agents that can enhance the antitumor effects of paclitaxel without further increasing undesirable side effects.
- Conditions
- Melanoma
- Being tested
- STA-4783, Paclitaxel
- Keywords
- metastatic, increased antitumor effect
- 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.
STA-4783Drug
PaclitaxelDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2004 (estimated)
- Study startMay 2004
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.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 103 participants
Sponsor and investigators
- Lead sponsor
- Synta Pharmaceuticals Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00084214
- Sponsor's protocol ID
- 4783-03
- Status last verified
- Dec 2008
- First submitted
- 9 Jun 2004
- Last updated
- 6 Mar 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-Stage Trial of STA-4783 in Combination With Weekly Paclitaxel for Treatment of Patients With Metastatic Melanoma
- ClinicalTrials.gov ID
- NCT00084214
- Acronym / sponsor ID
- 4783-03
- Conditions
- Melanoma
- Keywords
- metastatic, increased antitumor effect
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants
- Lead sponsor
- Synta Pharmaceuticals Corp.Industry (pharma, biotech, devices)
- Study start
- May 2004
- First posted
- 10 Jun 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 study is designed to assess the efficacy of a weekly treatment regimen of STA-4783 and paclitaxel in comparison to paclitaxel alone on tumor response in metastatic melanoma patients.
Detailed description
STA-4783 is a taxane potentiator, enhancing the effect of antitumor response of paclitaxel. In an attempt to improve efficacy, paclitaxel is sometimes used in combination with other anticancer agents. When paclitaxel is combined with other anticancer agents, although response rate is usually increased, side effects are usually increased as well. There is an urgent need for agents that can enhance the antitumor effects of paclitaxel without further increasing undesirable side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- M or F 18 or older with histologically confirmed metastatic (Stage IV) melanoma of cutaneous origin
- ECOG performance status of greater than or equal to 2
- Measurable disease per RECIST criteria
- Received no more than 1 regimen of prior chemotherapy (unlimited immunotherapy regimens are allowed)
- At least 4 weeks have passed since last chemotherapy or immunotherapy
Key exclusion criteria (8 listed)
- Female patients pregnant or lactating
- Female patients of childbearing potential not using or not willing to use effective contraception
- Presence of a second malignancy other than nonmelanoma skin cancer
- Presence of a clinically significant and uncontrolled infection
- Presence of clinically significant arrythmias
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 |
|---|---|---|
| STA-4783 | Drug | – |
| Paclitaxel | Drug | – |
Primary outcome
Not reported in the source record.
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 6 Mar 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing STA-4783 and Paclitaxel in people with Melanoma, run by Synta Pharmaceuticals Corp. at 28 sites 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 8 inclusion and 8 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 6 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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.
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 6 Mar 2014.