Multiple MyelomaPhase 1/2NCT00086216
Safety and Efficacy of Atiprimod for Patients With Refractory Multiple Myeloma
A Phase 1/2 study testing Atiprimod in people with Multiple Myeloma, run by Callisto Pharmaceuticals at 1 site in United States.
Trial summary
This is a Phase I/IIa clinical trial to identify the maximum tolerated dose of atiprimod and to evaluate the safety of atiprimod in patients with refractory or relapsed multiple myeloma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Atiprimod
- Type of treatment
- Pill or oral medicine
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- May 2004to Nov 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- documented history of multiple myeloma,
- failed at least two prior regimens for multiple myeloma,
- 18 years of age or older,
- ECOG(Zubrod)PS of 0 to 2,
- screening evaluation for determining eligibility prior to enrollment,
- signed informed consent form,
Who cannot join
- concomitant therapy medications including corticosteroids or other chemotherapy that is or may be active against myeloma ,
- renal insufficiency (serum creatinine levels of > 2mg/dL),
- mucosal bleeding,
- any condition which 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 co-morbid medical conditions.
- prior malignancy(within the last 3 years) except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient is has been disease-free for at least 3 years.
- patients with non-secretory myeloma.
- as atiprimod is a potent inhibitor or 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
Official title: An Open-Label Study of the Safety and Efficacy of Atiprimod Treatment for Patients With Refractory or Relapsed Multiple Myeloma
This is a Phase I/IIa clinical trial to identify the maximum tolerated dose of atiprimod and to evaluate the safety of atiprimod in patients with refractory or relapsed multiple myeloma.
Read the detailed description
This is a multi-center, open-label, dose escalation study intended to identify the MTD of atiprimod alone and the MTD of atiprimod when given in combination with ursodiol. The atiprimod dose will be escalated in sequential cohorts. Ten dose levels of atiprimod are planned for the atiprimod alone dose escalation: 30, 60, 90, 120, 180, 240, 300, 360, 420, and 480 mg/day to be given orally. Six dose levels of atiprimod are planned for the atiprimod in combination with ursodiol dose escalation: 180, 240, 300, 360, 420, and 480 mg/day to be given orally. The dose of ursodiol will remain constant for all cohorts (300 mg ursodiol orally three times a day everyday). Up to 105 patients will participate depending on the level at which toxicity is observed. Patients will be assigned to dose level in the order of study entry.
- Conditions
- Multiple Myeloma
- Being tested
- Atiprimod
- Keywords
- Multiple myeloma
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtiprimodDrug
Oral, once a day, 14 days on 14 days off
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of this study is to identify the maximum tolerated dose
Measured: 1 year
Secondary outcomes (1)
The secondary objective of this study is to measure the pharmacokinetics of
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2004 (estimated)
- Study startMay 2004
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Callisto Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Gary Jacob, PhD, Study director, Callisto Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00086216
- Sponsor's protocol ID
- CP-101
- Other IDs
- efficacy, pharmacokinetics, research markers
- Status last verified
- Dec 2007
- First submitted
- 28 Jun 2004
- Last updated
- 21 Dec 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2007. 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 Refractory or Relapsed Multiple Myeloma
- ClinicalTrials.gov ID
- NCT00086216
- Acronym / sponsor ID
- CP-101
- Conditions
- Multiple Myeloma
- Keywords
- Multiple myeloma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Callisto PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- May 2004
- Study completion
- Nov 2007 (actual)
- First posted
- 30 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 is a Phase I/IIa clinical trial to identify the maximum tolerated dose of atiprimod and to evaluate the safety of atiprimod in patients with refractory or relapsed multiple myeloma.
Detailed description
This is a multi-center, open-label, dose escalation study intended to identify the MTD of atiprimod alone and the MTD of atiprimod when given in combination with ursodiol. The atiprimod dose will be escalated in sequential cohorts. Ten dose levels of atiprimod are planned for the atiprimod alone dose escalation: 30, 60, 90, 120, 180, 240, 300, 360, 420, and 480 mg/day to be given orally. Six dose levels of atiprimod are planned for the atiprimod in combination with ursodiol dose escalation: 180, 240, 300, 360, 420, and 480 mg/day to be given orally. The dose of ursodiol will remain constant for all cohorts (300 mg ursodiol orally three times a day everyday). Up to 105 patients will participate depending on the level at which toxicity is observed. Patients will be assigned to dose level in the order of study entry.
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 (6 listed)
- documented history of multiple myeloma,
- failed at least two prior regimens for multiple myeloma,
- 18 years of age or older,
- ECOG(Zubrod)PS of 0 to 2,
- screening evaluation for determining eligibility prior to enrollment,
Key exclusion criteria (8 listed)
- concomitant therapy medications including corticosteroids or other chemotherapy that is or may be active against myeloma ,
- renal insufficiency (serum creatinine levels of > 2mg/dL),
- mucosal bleeding,
- any condition which 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 co-morbid medical conditions.
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 |
|---|---|---|
| AtiprimodOral, once a day, 14 days on 14 days off | Drug | – |
Primary outcome
The primary objective of this study is to identify the maximum tolerated dose
Time frame: 1 year
1 secondary outcome
The secondary objective of this study is to measure the pharmacokinetics of
Time frame: 1 year
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 21 Dec 2007.
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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.
Gary Jacob, PhD study director
Callisto Pharmaceuticals
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 Multiple Myeloma, 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 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 21 Dec 2007. 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?
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 objective of this study is to identify the maximum tolerated dose (time frame: 1 year). 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 21 Dec 2007.