MyelomaPhase 2NCT00242827
Efficacy and Safety of Oral CEP-701 for the Treatment of Patients With Advanced Multiple Myeloma
A Phase 2 study testing Oral CEP-701 in people with Myeloma, run by Cephalon at 5 sites in United States.
Trial summary
An Open-Label Study of the Efficacy and Safety of Oral CEP-701 for the Treatment of Patients with Advanced Multiple Myeloma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myeloma
- What is being tested?
- Oral CEP-701
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- 5 sitesUnited States
- Study dates
- Apr 2006to May 2007
- Phase
- Phase 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
- Patients are included in the study if all of the following criteria are met:
- Histological and cytological confirmation of stage II or III multiple myeloma.
- Relapsed or primary refractory multiple myeloma, after 1 or more courses of standard therapy, and progressive disease.
- ECOG performance status of 0-1.
- Measurable disease as defined by serum M protein of more than 1.0 gm/dl, serum light chain of more than 200 mg/dL, or Bence-Jones proteinuria of more than 200mg/24 hours.
- At least 18 years of age.
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- Normal marrow function: ANC>1.0x10 9/L, platelets>50X10 9/L An exception is allowed if myelosuppression or thrombocytopenia is secondary to bone marrow plasmacytosis. Growth factor support is allowed.
- Normal organ function: bilirubin <1.5XULN, AST and ALT<2XULN, serum creatinine <2.0 mg/dL.
- Contraceptive measures during participation as appropriate.
- Willing to be able to comply with study procedures and restrictions.
- Signed written informed consent.
Who cannot join
- Patients are excluded from participating in this study if 1 or more of the following criteria are met:
- Nonsecretory disease or plasma cell leukemia (defined as >2000 circulating plasma cells/uL).
- More than 4 prior courses if anticancer therapy (bisphosphonates are not considered anticancer therapy for this criterion)
- Chemotherapy or radiotherapy within 4 weeks prior to enrollment
- Unresolved adverse events or uncontrolled illness that would be likely to interfere with the objectives of the study.
- Treatment with an investigational drug within 4 weeks of first day of study treatment
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- History of second cancer (except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease free more than 5 years).
- Treatment with potent CYP3A4 inhibitors including cyclosporine, clotrimazole, fluconazole, itraconazole, ketoconazole, voriconazole, erythromycin, clarithromycin, and troleandomycin, human immunodeficiency virus (HIV), protease inhibitors, or nefazodone within 1 week (7 days) of the planned 1st day of study treatment.
- Currently receiving warfarin.
- Clinical diagnosis of active gastrointestinal ulceration of melena or hematemesis in the previous 4 weeks.
- Hypersensitivity to CEP701 or any component of CEP701.
- Intolerance of dexamethasone.
- Requirement for HIV protease inhibitor treatment.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Emory University Winship Cancer Institute
Atlanta, Georgia, 30302
The Cancer Center Hackensack University Medical Center
Hackensack, New Jersey, 07601
Indiana Univeristy Cancer Research Center
Indianapolis, Indiana, 46202
New York Presbyterian Hospital
New York, New York, 10021
Abramson Cancer Center Of University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: An Open-Label Study of the Efficacy and Safety of Oral CEP-701 for the Treatment of Patients With Advanced Multiple Myeloma
An Open-Label Study of the Efficacy and Safety of Oral CEP-701 for the Treatment of Patients with Advanced Multiple Myeloma.
Read the detailed description
An Open-Label Study of the Efficacy and Safety of Oral CEP-701 for the Treatment of Patients with Advanced Multiple Myeloma.
- Conditions
- Myeloma
- Being tested
- Oral CEP-701
- Medical subject headings
- Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral CEP-701Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2005 (estimated)
- Study startApr 2006
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Cephalon
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Peter Brown, Study director, Cephalon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00242827
- Sponsor's protocol ID
- C0701/2025/ON/US
- Status last verified
- Sep 2006
- First submitted
- 27 Sep 2005
- Last updated
- 23 Aug 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study of the Efficacy and Safety of Oral CEP-701 for the Treatment of Patients With Advanced Multiple Myeloma
- ClinicalTrials.gov ID
- NCT00242827
- Acronym / sponsor ID
- C0701/2025/ON/US
- Conditions
- Myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Lead sponsor
- CephalonIndustry (pharma, biotech, devices)
- Study start
- Apr 2006
- Study completion
- May 2007
- First posted
- 21 Oct 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.
An Open-Label Study of the Efficacy and Safety of Oral CEP-701 for the Treatment of Patients with Advanced Multiple Myeloma.
Detailed description
An Open-Label Study of the Efficacy and Safety of Oral CEP-701 for the Treatment of Patients with Advanced Multiple Myeloma.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- 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 (11 listed)
- Histological and cytological confirmation of stage II or III multiple myeloma.
- Relapsed or primary refractory multiple myeloma, after 1 or more courses of standard therapy, and progressive disease.
- ECOG performance status of 0-1.
- Measurable disease as defined by serum M protein of more than 1.0 gm/dl, serum light chain of more than 200 mg/dL, or Bence-Jones proteinuria of more than 200mg/24 hours.
- At least 18 years of age.
Key exclusion criteria (13 listed)
- Patients are excluded from participating in this study if 1 or more of the following criteria are met:
- Nonsecretory disease or plasma cell leukemia (defined as >2000 circulating plasma cells/uL).
- More than 4 prior courses if anticancer therapy (bisphosphonates are not considered anticancer therapy for this criterion)
- Chemotherapy or radiotherapy within 4 weeks prior to enrollment
- Unresolved adverse events or uncontrolled illness that would be likely to interfere with the objectives of 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 |
|---|---|---|
| Oral CEP-701 | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2012.
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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.
Peter Brown study director
Cephalon
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oral CEP-701 in people with Myeloma, run by Cephalon at 5 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 11 inclusion and 13 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 23 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 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 was stopped early. 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.
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 Aug 2012.