Refractory Multiple MyelomaPhase 1NCT00912899
A Study of Noscapine HCl (CB3304 ) in Patients With Relapsed or Refractory Multiple Myeloma
A Phase 1 study testing Noscapine HCl in people with Refractory Multiple Myeloma, run by Cougar Biotechnology, Inc. at 4 sites in United States.
Trial summary
This is a phase 1 study to evaluate the safety and determine maximum tolerated dose, safety \& tolerability of noscapine HCl in patients with advanced multiple myeloma Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractory Multiple Myeloma
- What is being tested?
- Noscapine HCl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 4 sitesUnited States
- Study dates
- Dec 2007to Jul 2010
- Phase
- Phase 1
- 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 Multiple Myeloma.
- Progression after ≥ 2 lines of prior therapy, including at least one steroid, one immunomodulatory agent (iMID), one alkylator, and bortezomib (VELCADE®).
- ECOG performance status of either 0 or 1.
Who cannot join
- Prior chemotherapy with antimicrotubule agents
- Metastasis involving the brain or spinal cord
- Clinically significant lung or heart disease
- Abnormal electrocardiogram
- Please note that there are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.
- Site personnel will explain the trial in detail and answer any question you may have if you do qualify for the study. You can then decide whether or not you wish to participate. If you do not qualify for the trial, site personnel will explain the reasons.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
UCLA
Los Angeles, California, 90024
St. Vincent's Comprehensive Cancer Center
New York, New York, 10011
Weill Medical College of Cornell University
New York, New York, 10021
Columbia Presbyterian Hospital
New York, New York, 10032
About this study
Official title: A Phase I Open Label Study of Noscapine HCl (CB3304 ) in Patients With Relapsed or Refractory Multiple Myeloma
This is a phase 1 study to evaluate the safety and determine maximum tolerated dose, safety \& tolerability of noscapine HCl in patients with advanced multiple myeloma
- Conditions
- Refractory Multiple Myeloma
- Being tested
- Noscapine HCl
- Keywords
- Refractory Multiple Myeloma, CB3304, Noscapine HCl, 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.
Noscapine HClDrug
Also called Noscapine HCl (CB3304)
Escalating doses given twice per day
| Study group | Role | What they receive |
|---|---|---|
| One | Experimental | Noscapine HCl Receives: Drug: Noscapine HCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the maximum tolerated dose
Measured: During the first 28 day treatment cycle
Secondary outcomes (3)
To determine the safety and tolerability in the study population
Measured: End of the study treatment
To evaluate the pharmacokinetics of study drug
Measured: End of the study treatment
To assess anti-tumor effects as classified by International Uniform Response Criteria for Multiple Myeloma
Measured: End of the study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2009 (estimated)
- Study startDec 2007
- Primary completionJul 2010
- Study completionJul 2010
Why it stopped: Terminated early due to lack of clinical response.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cougar Biotechnology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00912899
- Sponsor's protocol ID
- COU-NOS-001
- Status last verified
- Sep 2016
- First submitted
- 2 Jun 2009
- Last updated
- 7 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Open Label Study of Noscapine HCl (CB3304 ) in Patients With Relapsed or Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT00912899
- Acronym / sponsor ID
- COU-NOS-001
- Conditions
- Refractory Multiple Myeloma
- Keywords
- Refractory Multiple Myeloma, CB3304, Noscapine HCl, Multiple Myeloma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated early due to lack of clinical response.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Cougar Biotechnology, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 3 Jun 2009 (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 1 study to evaluate the safety and determine maximum tolerated dose, safety \& tolerability of noscapine HCl in patients with advanced multiple myeloma
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| One | Experimental | Drug: Noscapine HClNoscapine HCl |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Advanced Multiple Myeloma.
- Progression after ≥ 2 lines of prior therapy, including at least one steroid, one immunomodulatory agent (iMID), one alkylator, and bortezomib (VELCADE®).
- ECOG performance status of either 0 or 1.
Key exclusion criteria (6 listed)
- Prior chemotherapy with antimicrotubule agents
- Metastasis involving the brain or spinal cord
- Clinically significant lung or heart disease
- Abnormal electrocardiogram
- Please note that there are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.
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 |
|---|---|---|
| Noscapine HClAlso: Noscapine HCl (CB3304)Escalating doses given twice per day | Drug | One |
Primary outcome
To determine the maximum tolerated dose
Time frame: During the first 28 day treatment cycle
3 secondary outcomes
To determine the safety and tolerability in the study population
Time frame: End of the study treatment
To evaluate the pharmacokinetics of study drug
Time frame: End of the study treatment
To assess anti-tumor effects as classified by International Uniform Response Criteria for Multiple Myeloma
Time frame: End of the study treatment
Results and safety
The study was stopped early (reason given: Terminated early due to lack of clinical response.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2016.
- COUGAR BIOTECHNOLOGYLink provided by the sponsor.
- NATIONAL CANCER INSTITUTELink provided by the sponsor.
- MEDLINE PLUSLink provided by the sponsor.
- MULTIPLE MYELOMALink provided by the sponsor.
Related trials for Refractory Multiple Myeloma
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Testing GDC-0032 (Taselisib) as a Potential Targeted Treatment in Cancers With PIK3CA Genetic Changes (MATCH-Subprotocol I)
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Noscapine HCl in people with Refractory Multiple Myeloma, run by Cougar Biotechnology, Inc. at 4 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 3 inclusion and 6 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: stopped early, as of the sponsor's last update on 7 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 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.
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 was stopped early (reason given: Terminated early due to lack of clinical response.). 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?
To determine the maximum tolerated dose (time frame: During the first 28 day treatment cycle). 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 7 Oct 2016.