MelanomaPhase 2NCT00189332
Use of 852A in Metastatic Cutaneous Melanoma.
A Phase 2 study testing 852A in people with Melanoma and Unresectable Metatstatic Cutaneous Melanoma, run by Pfizer at 8 sites in 3 countries.
Trial summary
Pilot study to test the efficacy of 852A administered intravenously up to 3 times per week for 12 weeks in subjects with inoperable metastatic cutaneous melanoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma, Unresectable Metatstatic Cutaneous Melanoma
- What is being tested?
- 852A
- How many people
- 28 participants
- Where
- 8 sitesin 3 countries
- Study dates
- Feb 2005to Aug 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
- Advanced melanoma not responding to 1st line chemotherapy
- Histological evidence of melanoma
- Measurable disease according to RECIST criteria
- ECOG performance status less than or equal to 2
- Life expectancy 6 months or more
- Normal organ and bone marrow function as defined by hematological and serum chemistry limits
- Adequate contraception for females of childbearing potential
Who cannot join
- Stage IV disease which has previously progressed during interferon treatment.
- Restriction of some therapies/medications for a certain timeframe prior to enrollment and during the study including: investigational drugs, high dose corticosteroids, immunotherapy, immunosuppressive medications, radiotherapy and drugs known to prolong QT interval and/or induce Torsades De Pointes
- History of uncontrolled seizure disorders
- Uncontrolled coagulation disorders.
- History or evidence of myocardial ischemia, congestive heart failure or arrythmias requiring treatment in the past 6 months
- History of uncontrolled intercurrent or chronic illness
Show all 12Show fewer
- Concurrent malignancies.
- Brain metastases.
- HIV positive.
- Prolonged QTc interval
- Uncontrolled intercurrent or chronic illnesses.
- Pregnant or lactating women
Trial locations and contacts
8 sites in 3 countries.
8 sites in 3 countries
Germany5 sites
Hautklinik, Medizinische Einrichtungen der Heinrich-Heine - Universität Düsseldorf
Düsseldorf
Klinik und Poliklinik für Dermatologie und Venerologie Universitätsklinikum Essen
Essen
Universitätsklinikum Schleswig-Holstein Campus Kiel
Kiel
(DKFZ) an der Universitäts-Hautklinik Mannheim
Mannheim
Universitätsklinik und Poliklinik für Hautkrankheiten
Würzburg
France2 sites
Hôpital Hotel Dieu, 1, Pace de l' Hôpital,
Lyon
Hôpital Ste Marguerite,Service de Dermatologie
Marseille
About this study
Official title: Pilot Phase II, Open Label, Multicenter, Efficacy and Safety Study of 852A Administered Intravenously to Subjects With Unresectable Metastatic Cutaneous Melanoma.
Pilot study to test the efficacy of 852A administered intravenously up to 3 times per week for 12 weeks in subjects with inoperable metastatic cutaneous melanoma.
- Being tested
- 852A
- Keywords
- Oncology, Melanoma
- Medical subject headings
- Melanoma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
852ADrug
What is being measured
The primary outcome is the main question the study is designed to answer.
assessing antitumor activity of 852A intravenous bolus injection administered 3 times a week for 12 weeks
Secondary outcomes (2)
to assess the safety of the dosage regiment over 12 weeks
to obtain preliminary data regarding the safety and long term efficacy of 852A in subjects treated with the drug for more than 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startFeb 2005
- Primary completionAug 2006
- Study completionAug 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 PfizerThe 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
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00189332
- Sponsor's protocol ID
- 1527-852A
- Status last verified
- Oct 2008
- First submitted
- 13 Sep 2005
- Last updated
- 27 Oct 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Phase II, Open Label, Multicenter, Efficacy and Safety Study of 852A Administered Intravenously to Subjects With Unresectable Metastatic Cutaneous Melanoma.
- ClinicalTrials.gov ID
- NCT00189332
- Acronym / sponsor ID
- 1527-852A
- Keywords
- Oncology, Melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Feb 2005
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 19 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.
Pilot study to test the efficacy of 852A administered intravenously up to 3 times per week for 12 weeks in subjects with inoperable metastatic cutaneous melanoma.
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 (7 listed)
- Advanced melanoma not responding to 1st line chemotherapy
- Histological evidence of melanoma
- Measurable disease according to RECIST criteria
- ECOG performance status less than or equal to 2
- Life expectancy 6 months or more
Key exclusion criteria (12 listed)
- Stage IV disease which has previously progressed during interferon treatment.
- Restriction of some therapies/medications for a certain timeframe prior to enrollment and during the study including: investigational drugs, high dose corticosteroids, immunotherapy, immunosuppressive medications, radiotherapy and drugs known to prolong QT interval and/or induce Torsades De Pointes
- History of uncontrolled seizure disorders
- Uncontrolled coagulation disorders.
- History or evidence of myocardial ischemia, congestive heart failure or arrythmias requiring treatment in the past 6 months
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 |
|---|---|---|
| 852A | Drug | – |
Primary outcome
assessing antitumor activity of 852A intravenous bolus injection administered 3 times a week for 12 weeks
2 secondary outcomes
to assess the safety of the dosage regiment over 12 weeks
to obtain preliminary data regarding the safety and long term efficacy of 852A in subjects treated with the drug for more than 12 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 27 Oct 2008.
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.
The record lists no contact. Use the official record to reach the sponsor.
8 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 852A in people with Melanoma and Unresectable Metatstatic Cutaneous Melanoma, run by Pfizer at 8 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 7 inclusion and 12 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 27 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Germany, France, Switzerland. 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?
assessing antitumor activity of 852A intravenous bolus injection administered 3 times a week for 12 weeks. 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 27 Oct 2008.