Prostate CancerPhase 1/2NCT00087854
Study of Individualized Amonafide to Treat Prostate Cancer
A Phase 1/2 study testing Amonafide L-malate (drug) in people with Prostate Cancer, run by Xanthus Pharmaceuticals, Inc. at 8 sites in United States.
Trial summary
The purpose of this study is to assess the safety and efficacy of Amonafide in men with androgen-independent prostate cancer, assigned to individualized doses of Amonafide based on acetylator phenotype information (doses adjusted on individual metabolism). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Amonafide L-malate (drug)
- How many people
- 40 participants
- Where
- 8 sitesUnited States
- Study dates
- Mar 2004to Dec 2005
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men 18 years or older;
- Metastatic androgen-independent prostate cancer with evidence of progression;
- Zero or one prior course of chemotherapy for metastatic disease;
- Up to two prior courses of non-cytotoxic therapies for metastatic disease;
- Progressive measurable or assessable disease;
- Evidence of continued elevation of PSA despite antiandrogen withdrawal;
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- ECOG Performance Status < 2 with an expected survival of at least 6 months;
- Adequate renal function;
- Adequate hepatic function;
- Adequate hematologic status;
- No other prior malignancy is allowed except for the following: adequately-treated basal cell or squamous cell skin cancer, adequately treated Stage I or II bladder cancer from which the subject is currently in complete remission, or any other cancer from which the subject has been disease free for 5 years;
- Subjects must have recovered from all acute toxicities from prior treatment;
- Screening visit phenotyping procedures must have been completed successfully;
- No blood transfusion within the previous 2 weeks of signature of the informed consent;
- Expected cooperation of the subject for the treatment and follow up must be obtained and documented;
- Written informed consent must be obtained and documented.
Who cannot join
- Clinically significant abnormal hematological parameters other than those defined in the inclusion criteria;
- Clinically significant abnormal biochemical parameters other than those defined in the inclusion criteria;
- Subjects who have been receiving bisphosphonates for less than three months prior to the first Amonafide administration;
- Known history of brain metastases;
- Subjects who are HIV positive;
- Subjects who are hepatitis B surface antigen positive or have previously documented hepatitis C infection;
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- Subjects who received treatment with Growth Factors (i.e. G-CSF, GM-CSF) within 2 weeks of the signature of the informed consent form;
- Subjects who had any major surgery within four weeks of first administration of Amonafide;
- Subjects with a history of a psychological illness or condition which may interfere with the subjects ability to understand or comply with the requirements of the study;
- Subjects who received an investigational new drug within 30 days of the first dose of Amonafide;
- Any other known condition, which in the investigator's opinion would not make the subject a good candidate for the trial.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Cancer Center at John Hopkins
Baltimore, Maryland, 21231
The Cleveland Clinic
Cleveland, Ohio, 44195
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
Herbert Irving Cancer Center
New York, New York, 10032-3789
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111-2497
Seattle Cancer Care Alliance
Seattle, Washington, 98109
Barnard Cancer Center
St Louis, Missouri, 63110
About this study
Official title: Dose-Defining Study of a NAT2 Phenotype-Based Dosing Regimen of Intravenous Amonafide L-Malate Administered Weekly in Men With Androgen-Independent Prostate Cancer (AIPC)
The purpose of this study is to assess the safety and efficacy of Amonafide in men with androgen-independent prostate cancer, assigned to individualized doses of Amonafide based on acetylator phenotype information (doses adjusted on individual metabolism).
Read the detailed description
This is an open-label, Phase I/II, multicenter study of Amonafide in subjects with androgen-independent metastatic prostate cancer.
Amonafide is metabolized by N-acetylation to an active metabolite, N-acetyl-Amonafide. Inter-subject differences in N-acetylation can explain the variability in Amonafide-induced myelosuppression. This dose-defining protocol has been designed to assess safety and efficacy of Amonafide in men with androgen-independent prostate cancer, assigned to individualized doses based on acetylator phenotype information.
The total duration of this study will be approximately 12 - 16 months: approximately 6 - 10 months for enrollment, and approximately 6 months for subject screening, treatment, and follow up per protocol. Subjects will be treated until PSA progression, disease progression, or unacceptable toxicity.
Subjects may continue participation in the study after Cycle 5 at the investigator's discretion if PSA progression, disease progression, or unacceptable toxicities are not reported. If a subject fulfills a criterion of PSA progression or disease progression, yet in the opinion of the investigator, the subject appears to be deriving clinical benefit from the study medication, a request may be made to the Xanthus medical monitor to allow that subject to continue study participation on a compassionate basis.
A follow-up evaluation for all subjects will be done 30 - 35 days after receiving the last dose of Amonafide. Subjects will be contacted every 3 months for survival after completion of the active phase of the study, until death.
PSA response will be reported for all subjects receiving Amonafide treatment. PSA levels will be measured at Screening and once per treatment cycle thereafter (at Day 1 of each cycle). A PSA responder will be defined as a subject experiencing a 50% decrease in PSA level, confirmed four or more weeks later, with no demonstration of clinical or radiographic evidence of disease progression prior to the second PSA measurement. Duration PSA response and time to PSA progression will also be reported.
In addition to PSA endpoints, traditional response criteria such as overall tumor response rate (complete + partial tumor response), duration of tumor response, and time to tumor progression will be captured for all subjects with measurable lesions. All complete and partial responses must be confirmed by repeat assessments that should be performed no less than 4 weeks after the criteria for response are met.
Subsequently, in order to evaluate safety, all subjects will be assessed for signs of adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3 dated June 10, 2003.
All serious adverse events (SAEs) and grade ¾ toxicities will be reviewed by the Sponsor's medical monitor. Appropriate action may be taken to terminate or put the study on hold if warranted by unanticipated toxicity.
- Conditions
- Prostate Cancer
- Being tested
- Amonafide L-malate (drug)
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amonafide L-malate (drug)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
The Primary Objectives of this study are:
To define and validate the safety of a NAT2 pheontypically driven dosing regimen;
To define the pharmacokinetic and pharmacodynamic profile of Amonafide with a weekly intravenous administration schedule.
Secondary outcomes (3)
The Secondary Objectives of this study are:
To determine the efficacy of weekly intravenous Amonafide for all enrolled subjects as defined by PSA response (decrease in PSA of 50% or greater), duration of PSA response, and time to PSA progression;
To determine the overall tumor response (e.g., complete response or partial response), duration of tumor response, and time to tumor progression among subjects with measurable lesions using standard (RECIST) criteria.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2004 (estimated)
- Study startMar 2004
- Primary completionDec 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Xanthus Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Michel Drouin, MD, Study chair, Xanthus Life Sciences-Medical MonitorMonique Champagne, BPharm, MSc, Study director, Xanthus Pharmaceuticals, Inc.Mario Eisenberger, MD, Principal investigator, Johns Hopkins University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00087854
- Sponsor's protocol ID
- 0001A2-200-US
- Status last verified
- Apr 2008
- First submitted
- 14 Jul 2004
- Last updated
- 23 Apr 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-Defining Study of a NAT2 Phenotype-Based Dosing Regimen of Intravenous Amonafide L-Malate Administered Weekly in Men With Androgen-Independent Prostate Cancer (AIPC)
- ClinicalTrials.gov ID
- NCT00087854
- Acronym / sponsor ID
- 0001A2-200-US
- Conditions
- Prostate Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- Xanthus Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2004
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 16 Jul 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.
The purpose of this study is to assess the safety and efficacy of Amonafide in men with androgen-independent prostate cancer, assigned to individualized doses of Amonafide based on acetylator phenotype information (doses adjusted on individual metabolism).
Detailed description
This is an open-label, Phase I/II, multicenter study of Amonafide in subjects with androgen-independent metastatic prostate cancer.
Amonafide is metabolized by N-acetylation to an active metabolite, N-acetyl-Amonafide. Inter-subject differences in N-acetylation can explain the variability in Amonafide-induced myelosuppression. This dose-defining protocol has been designed to assess safety and efficacy of Amonafide in men with androgen-independent prostate cancer, assigned to individualized doses based on acetylator phenotype information.
The total duration of this study will be approximately 12 - 16 months: approximately 6 - 10 months for enrollment, and approximately 6 months for subject screening, treatment, and follow up per protocol. Subjects will be treated until PSA progression, disease progression, or unacceptable toxicity.
Subjects may continue participation in the study after Cycle 5 at the investigator's discretion if PSA progression, disease progression, or unacceptable toxicities are not reported. If a subject fulfills a criterion of PSA progression or disease progression, yet in the opinion of the investigator, the subject appears to be deriving clinical benefit from the study medication, a request may be made to the Xanthus medical monitor to allow that subject to continue study participation on a compassionate basis.
A follow-up evaluation for all subjects will be done 30 - 35 days after receiving the last dose of Amonafide. Subjects will be contacted every 3 months for survival after completion of the active phase of the study, until death.
PSA response will be reported for all subjects receiving Amonafide treatment. PSA levels will be measured at Screening and once per treatment cycle thereafter (at Day 1 of each cycle). A PSA responder will be defined as a subject experiencing a 50% decrease in PSA level, confirmed four or more weeks later, with no demonstration of clinical or radiographic evidence of disease progression prior to the second PSA measurement. Duration PSA response and time to PSA progression will also be reported.
In addition to PSA endpoints, traditional response criteria such as overall tumor response rate (complete + partial tumor response), duration of tumor response, and time to tumor progression will be captured for all subjects with measurable lesions. All complete and partial responses must be confirmed by repeat assessments that should be performed no less than 4 weeks after the criteria for response are met.
Subsequently, in order to evaluate safety, all subjects will be assessed for signs of adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3 dated June 10, 2003.
All serious adverse events (SAEs) and grade ¾ toxicities will be reviewed by the Sponsor's medical monitor. Appropriate action may be taken to terminate or put the study on hold if warranted by unanticipated toxicity.
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
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Men 18 years or older;
- Metastatic androgen-independent prostate cancer with evidence of progression;
- Zero or one prior course of chemotherapy for metastatic disease;
- Up to two prior courses of non-cytotoxic therapies for metastatic disease;
- Progressive measurable or assessable disease;
Key exclusion criteria (11 listed)
- Clinically significant abnormal hematological parameters other than those defined in the inclusion criteria;
- Clinically significant abnormal biochemical parameters other than those defined in the inclusion criteria;
- Subjects who have been receiving bisphosphonates for less than three months prior to the first Amonafide administration;
- Known history of brain metastases;
- Subjects who are HIV positive;
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 |
|---|---|---|
| Amonafide L-malate (drug) | Drug | – |
Primary outcome
The Primary Objectives of this study are:
To define and validate the safety of a NAT2 pheontypically driven dosing regimen;
To define the pharmacokinetic and pharmacodynamic profile of Amonafide with a weekly intravenous administration schedule.
3 secondary outcomes
The Secondary Objectives of this study are:
To determine the efficacy of weekly intravenous Amonafide for all enrolled subjects as defined by PSA response (decrease in PSA of 50% or greater), duration of PSA response, and time to PSA progression;
To determine the overall tumor response (e.g., complete response or partial response), duration of tumor response, and time to tumor progression among subjects with measurable lesions using standard (RECIST) criteria.
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 23 Apr 2008.
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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.
Michel Drouin, MD study chair
Xanthus Life Sciences-Medical Monitor
Monique Champagne, BPharm, MSc study director
Xanthus Pharmaceuticals, Inc.
Mario Eisenberger, MD principal investigator
Johns Hopkins University Hospital
8 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 Amonafide L-malate (drug) in people with Prostate Cancer, run by Xanthus Pharmaceuticals, Inc. at 8 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 16 inclusion and 11 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 23 Apr 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 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.
What does the primary outcome measure?
The Primary Objectives of this study are:. The study lists 3 primary outcomes in all. 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 23 Apr 2008.