Advanced CancerPhase 1/2NCT00214838
An Open-Label Study of the Safety and Efficacy of Atiprimod Treatment for Patients With Advanced Cancer
A Phase 1/2 study testing Atiprimod in people with Advanced Cancer, run by Callisto Pharmaceuticals at 1 site in United States.
Trial summary
The primary objectives of this study are to identify the maximum tolerated dose and to evaluate safety of atiprimod in patients with advanced cancer. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- Atiprimod
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2005to Mar 2007
- 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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- histological proof of advanced cancer and must have failed or relapsed following standard therapy or have no standard therapy available.
- estimated life expectancy of at least 12 weeks.
- must have evaluable disease.
- ECOG(Zubrod) PS of 0 to 2
- sign informed consent.
- age 13 years or more at time of signing informed consent.
Who cannot join
- renal insufficiency
- concomitant radiotherapy, chemotherapy or other investigational therapies.
- peripheral neuropathy grade 3 or greater (NCI CTC version 3 grading)
- evidence of clinically significant mucosal or internal bleeding
- any condition that in the opinion of the investigator, places the patient at unacceptable risk if he/she were to participate in the study.
- clinically relevant active infection or serious co-morbid medical conditions.
- as atiprimod is a potent inhibitor of CYP2D6, patients taking drugs that are substrates of CYP2D6(e.g. beta blockers, antidepressants and antipsychotics will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
The primary objectives of this study are to identify the maximum tolerated dose and to evaluate safety of atiprimod in patients with advanced cancer.
Read the detailed description
The primary objectives of this study are to identify the maximum tolerated dose(MTD) and to evaluate safety of atiprimod in patients with advanced cancer.
The secondary objectives of this study are 1) to measure the pharmacokinetics of atiprimod and 2) to evaluate the efficacy of atiprimod treatment in patients with advanced cancers and 3) to compare the pharmacokinetics of atiprimod tablets and capsules at the starting dose, with the intent of switching to capsules for the dose escalation if the capsules pose no safety issues.
- Conditions
- Advanced Cancer
- Being tested
- Atiprimod
- Keywords
- cancer, atiprimod
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtiprimodDrug
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 identify the maximum tolerated dose
MTD) and to evaluate the safety of atiprimod when given in doses starting at
60 mg/day and ranging to 360 mg/day, or the MTD, whichever is lower, in
patients with advanced cancer.
Secondary outcomes (5)
The secondary objectives of this study are to measure the pharmacokinetics of
atiprimod, to evaluate the efficacy of atiprimod treatment in patients with
advanced cancer, and to compare the pharmacokinetics of atiprimod tablets and
capsules at the starting dose, with the intent of switching to capsules for
the dose escalation if the capsules pose no safety issues.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startMar 2005
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced 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
- 61 participants
Sponsor and investigators
- Lead sponsor
- Callisto Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Donald Picker, PhD, Study director, Callisto Pharmaceuticals Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00214838
- Sponsor's protocol ID
- CP-102
- Status last verified
- Dec 2006
- First submitted
- 14 Sep 2005
- Last updated
- 5 Dec 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study of the Safety and Efficacy of Atiprimod Treatment for Patients With Advanced Cancer
- ClinicalTrials.gov ID
- NCT00214838
- Acronym / sponsor ID
- CP-102
- Conditions
- Advanced Cancer
- Keywords
- cancer, atiprimod
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 61 participants
- Lead sponsor
- Callisto PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2005
- Study completion
- Mar 2007
- First posted
- 22 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.
The primary objectives of this study are to identify the maximum tolerated dose and to evaluate safety of atiprimod in patients with advanced cancer.
Detailed description
The primary objectives of this study are to identify the maximum tolerated dose(MTD) and to evaluate safety of atiprimod in patients with advanced cancer.
The secondary objectives of this study are 1) to measure the pharmacokinetics of atiprimod and 2) to evaluate the efficacy of atiprimod treatment in patients with advanced cancers and 3) to compare the pharmacokinetics of atiprimod tablets and capsules at the starting dose, with the intent of switching to capsules for the dose escalation if the capsules pose no safety issues.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- histological proof of advanced cancer and must have failed or relapsed following standard therapy or have no standard therapy available.
- estimated life expectancy of at least 12 weeks.
- must have evaluable disease.
- ECOG(Zubrod) PS of 0 to 2
- sign informed consent.
Key exclusion criteria (7 listed)
- renal insufficiency
- concomitant radiotherapy, chemotherapy or other investigational therapies.
- peripheral neuropathy grade 3 or greater (NCI CTC version 3 grading)
- evidence of clinically significant mucosal or internal bleeding
- any condition that in the opinion of the investigator, places the patient at unacceptable risk if he/she were to participate in the study.
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 |
|---|---|---|
| Atiprimod | Drug | – |
Primary outcome
The primary objectives of this study are to identify the maximum tolerated dose
MTD) and to evaluate the safety of atiprimod when given in doses starting at
60 mg/day and ranging to 360 mg/day, or the MTD, whichever is lower, in
patients with advanced cancer.
5 secondary outcomes
The secondary objectives of this study are to measure the pharmacokinetics of
atiprimod, to evaluate the efficacy of atiprimod treatment in patients with
advanced cancer, and to compare the pharmacokinetics of atiprimod tablets and
capsules at the starting dose, with the intent of switching to capsules for
the dose escalation if the capsules pose no safety issues.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2006.
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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.
Donald Picker, PhD study director
Callisto Pharmaceuticals Inc
1 site 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 Atiprimod in people with Advanced Cancer, run by Callisto Pharmaceuticals 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 6 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 5 Dec 2006. 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 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?
Results are not available in the source record.
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 to identify the maximum tolerated dose. The study lists 4 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 5 Dec 2006.