Multiple MyelomaPhase 1NCT01199718
Study of CX-4945 in Patients With Relapsed or Refractory Multiple Myeloma
A Phase 1 study testing CX-4945 in people with Multiple Myeloma, run by Cylene Pharmaceuticals at 6 sites in United States.
Trial summary
This Phase 1 study of oral CX-4945 is designed to test the safety, tolerability, and highest safe dose level of this CK2 inhibitor in patients with relapsed or refractory 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?
- CX-4945
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 6 sitesUnited States
- Study dates
- Sep 2010to Sep 2011
- 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
- Males or females at least 18 years of age
- Confirmed relapsed or refractory multiple myeloma after at least two prior lines of therapy.
- Measureable disease.
- Karnofsky Performance Status at least 60%
- Adequate liver and renal function and hematology laboratory values
- Female patients of child-bearing potential must have a negative pregnancy test.
- Signed informed consent.
Who cannot join
- Treatment with systemic cancer therapy within 21 days before screening.
- Major surgery within 4 weeks or minor surgery within 2 weeks of the start of study drug.
- Grade 3 sensory neuropathy or motor neuropathy with pain
- Concurrent severe or uncontrolled medical disease.
- Active systemic fungal, bacterial, and/or viral infection.
- Difficulty with swallowing, or an active malabsorption syndrome.
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- Gastrointestinal diseases including Crohn's disease or hemorrhagic coloproctitis.
- History of gastric or small bowel surgery.
- Pregnant or nursing females.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
Study site
Greenville, South Carolina, 29605
Jan Kueber, RN, jkueber@ghs.org
- Recruiting
Study site
Kettering, Ohio, 45249
Michelle Owens, RN, michelle.owens@khnetwork.org
- Recruiting
Study site
Norfolk, Virginia, 23502
Gabrielle Geho, RN, Gabrielle.Geho@usoncology.com
- Recruiting
Oregon Health Science University
Portland, Oregon, 97239
Farnoush Abar, MD, abarfa@ohsu.edu
- Recruiting
Study site
Springfield, Oregon, 97477
Jeanne Schaffer, RN, jeanne.schaffer@usoncology.com
- Recruiting
Study site
Yakima, Washington, 98902
Jo Cook, jo.cook@yvmh.org
About this study
Official title: A Phase 1, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of CX-4945 Administered Orally to Patients With Relapsed or Refractory Multiple Myeloma
This Phase 1 study of oral CX-4945 is designed to test the safety, tolerability, and highest safe dose level of this CK2 inhibitor in patients with relapsed or refractory multiple myeloma.
Read the detailed description
Elevated CK2 activity has been associated with malignant transformation and aggressive tumor growth. Over expression of CK2 has been documented in multiple types of cancers, including multiple myeloma, and inhibition of CK2 represents a potential therapeutic strategy to target a specific molecular defect perpetuating many cancers. CX-4945 has demonstrated potent inhibition of CK2 enzymatic activity. This study will evaluate the safety, pharmacokinetics, and pharmacodynamic effects of CX-4945 when administered to patients with multiple myeloma.
- Conditions
- Multiple Myeloma
- Being tested
- CX-4945
- Keywords
- Multiple myeloma, Plasmacytoma
- Medical subject headings
- Multiple Myeloma, Plasmacytoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CX-4945Drug
CX-4945 capsules, administered orally,as escalating doses. Dose schedule: four times daily for 21 consecutive days every 28 days.
| Study group | Role | What they receive |
|---|---|---|
| CX-4945 | Experimental | CX-4945 oral formulation Receives: Drug: CX-4945 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Adverse events classified as Dose limiting toxicities. Determination of maximum tolerated dose.
Measured: One year (assessed at Cycle 1).
Secondary outcomes (3)
Pharmacokinetic and pharmacodynamic assessments.
Blood levels of study drug when administered in escalating doses and modulation of biomarkers for CK2.
Measured: One year - assessed throughout all cycles of participation
Assess for efficacy response
Response assessments including M-protein levels as detailed by the International Myeloma Working Group Uniform Response Criteria.
Measured: One year (assessed after each cycle)
Establish the recommended Phase 2 dose
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionJun 2011 (estimated)
- Study completionSep 2011 (estimated)
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cylene Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Study Director, Study director, Cylene Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01199718
- Sponsor's protocol ID
- C4-09-001
- Status last verified
- Jun 2011
- First submitted
- 9 Sep 2010
- Last updated
- 15 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of CX-4945 Administered Orally to Patients With Relapsed or Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT01199718
- Acronym / sponsor ID
- C4-09-001
- Conditions
- Multiple Myeloma
- Keywords
- Multiple myeloma, Plasmacytoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Cylene PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Jun 2011 (estimated)
- Study completion
- Sep 2011 (estimated)
- First posted
- 13 Sep 2010 (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 Phase 1 study of oral CX-4945 is designed to test the safety, tolerability, and highest safe dose level of this CK2 inhibitor in patients with relapsed or refractory multiple myeloma.
Detailed description
Elevated CK2 activity has been associated with malignant transformation and aggressive tumor growth. Over expression of CK2 has been documented in multiple types of cancers, including multiple myeloma, and inhibition of CK2 represents a potential therapeutic strategy to target a specific molecular defect perpetuating many cancers. CX-4945 has demonstrated potent inhibition of CK2 enzymatic activity. This study will evaluate the safety, pharmacokinetics, and pharmacodynamic effects of CX-4945 when administered to patients with multiple myeloma.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CX-4945 | Experimental | Drug: CX-4945CX-4945 oral formulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Males or females at least 18 years of age
- Confirmed relapsed or refractory multiple myeloma after at least two prior lines of therapy.
- Measureable disease.
- Karnofsky Performance Status at least 60%
- Adequate liver and renal function and hematology laboratory values
Key exclusion criteria (9 listed)
- Treatment with systemic cancer therapy within 21 days before screening.
- Major surgery within 4 weeks or minor surgery within 2 weeks of the start of study drug.
- Grade 3 sensory neuropathy or motor neuropathy with pain
- Concurrent severe or uncontrolled medical disease.
- Active systemic fungal, bacterial, and/or viral infection.
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 |
|---|---|---|
| CX-4945CX-4945 capsules, administered orally,as escalating doses. Dose schedule: four times daily for 21 consecutive days every 28 days. | Drug | CX-4945 |
Primary outcome
Safety
Time frame: One year (assessed at Cycle 1).
Adverse events classified as Dose limiting toxicities. Determination of maximum tolerated dose.
3 secondary outcomes
Pharmacokinetic and pharmacodynamic assessments.
Time frame: One year - assessed throughout all cycles of participation
Assess for efficacy response
Time frame: One year (assessed after each cycle)
Establish the recommended Phase 2 dose
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2011.
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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.
Study Director study director
Cylene Pharmaceuticals
6 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 CX-4945 in people with Multiple Myeloma, run by Cylene Pharmaceuticals at 6 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 7 inclusion and 9 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 15 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (time frame: One year (assessed at Cycle 1).). 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 15 Jun 2011.