Trial · NCT00669578
CC-4047 in Treating Patients With Myelofibrosis
NCT00669578, Phase 1, Phase 2, Completed, Mayo Clinic; results first posted 2014-05-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. CC-4047 in Treating Patients With Myelofibrosis. Trials, record NCT00669578. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00669578
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- CC-4047 in Treating Patients With Myelofibrosis
- NCT number
- NCT00669578
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 77 participants, actual
- Lead sponsor
- Mayo Clinic
- Conditions
- Chronic Myeloproliferative Disorders, Secondary Myelofibrosis
- Interventions
- CC-4047
- First posted
- 2008-04-30
- Last updated
- 2019-12-30
- Results first posted
- 2014-05-09
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Determine the Maximum Tolerated Dose of CC-4047 | The first 28-day cycle of treatment. | Starting at a dose level of 2.5 mg/d on days 1-21 in every 28 day cycle, participants were accrued in cohorts of three to assess dose limiting toxicities (DLT) and determine the maximum tolerated dose (MTD). Dose escalation at increments of 0.5 mg/d was done if no subject had a DLT (a grade 4 or higher hematologic toxicity or a grade 3 or higher febrile neutropenia or a grade 3 or higher non-hematologic toxicity) in cycle 1. Subsequent cohorts were treated until the maximum tolerated dose (MTD) was reached (dose level before that which results in a DLT in \>1 of 6 subjects). Subsequent participants were treated at the MTD, those without response at the MTD after 3 cycles were lowered to the minimal efficacious dose (MED) of 0.5 mg daily. Here, we are reporting the percentage of participants in Phase I with a DLT at each dose level. |
| Primary | Best Overall Response Over the First 6 Cycles of Treatment | Every cycle of treatment for 6 cycles. Each cycle is 28 days. | Response evaluation: Complete Remission (CR): Neutrophil count between 1 to 10 x 10\^9/L without peripheral blasts in blood or bone marrow. Partial Hematologic Response/Partial Remission (PR): Increase in neutrophil by 50% + above 10\^9/L for neutropenia) Clinical Improvement (CI): Increase in Neutrophil count, hemoglobin, platelet count or reduction in blood/marrow blasts. |
| Secondary | Number of Participants With Treatment Related Adverse Events. | During treatment and every 6 months until 3 years from registration or progression. | Adverse events (AE) that are classified as either possibly, probably, or definitely related to study treatment according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE version 3.0). The maximum grade for each type of AE will be recorded for each patient. The number of participants with grade 3 or higher adverse events at least possibly related to study treatment are reported here. |
| Secondary | Duration of Response Time | Time from response to disease progression, intolerance of study drug, or death. | Duration of response is defined as the date at which the patient's objective status is first noted to be a CR, PR or CI to the date progression is documented (if one has occurred) or to the date of last follow-up(for those patients who have not progressed). |
| Secondary | Time to Response | Time from registration to the first date of response within twelve 28-day cycles of treatment. | The time to response is defined as the time from study registration to the first date at which the patient's objective status was classified as a response (CR, PR or CI). In patients who do not achieve a response, time to response will be censored at the patient's last evaluation date. The distribution for each of these event-time variables (duration of response and time to response) will be estimated by Kaplan-Meier curves. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Determine the Maximum Tolerated Dose of CC-4047 | The first 28-day cycle of treatment. | None of the Phase II participants were evaluable for this endpoint. For the Phase I portion of this study, three participants were accrued at a 2.5 mg/day dose level, six at the 3.0 mg/day dose level, and three at the 3.5 mg/day dose level. | percentage of participants with DLT | NUMBER |
| SECONDARY | Number of Participants With Treatment Related Adverse Events. | During treatment and every 6 months until 3 years from registration or progression. | None of the Phase I participants were used for this primary endpoint. All 65 Phase II participants were evaluable for this endpoint. | participants | NUMBER |
| SECONDARY | Duration of Response Time | Time from response to disease progression, intolerance of study drug, or death. | None of the Phase I participants were evaluable for this endpoint. Sixty-five (65) participants were recruited for the Phase II portion. Results presented here are on the 9 Phase II patients who responded to treatment. | Months | MEDIAN |
| SECONDARY | Time to Response | Time from registration to the first date of response within twelve 28-day cycles of treatment. | None of the Phase I participants were evaluable for this endpoint. Sixty-five (65) patients were recruited for the Phase II portion. Only 9 of the 65 patients achieved a response. Thus, the median of time to response and the upper limit of 95% confidence interval are not attainable. | ||
| PRIMARY | Best Overall Response Over the First 6 Cycles of Treatment | Every cycle of treatment for 6 cycles. Each cycle is 28 days. | None of the participants from the Phase I cohort were analyzed for this endpoint. All 65 Phase II participants were evaluable for this endpoint and included in the analysis. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Determine the Maximum Tolerated Dose of CC-4047 | Phase I | 2.5 mg/day | 0 | percentage of participants with DLT | |
| Determine the Maximum Tolerated Dose of CC-4047 | Phase I | 3.0 mg/day | 0 | percentage of participants with DLT | |
| Determine the Maximum Tolerated Dose of CC-4047 | Phase I | 3.5 mg/day | 66 | percentage of participants with DLT | |
| Number of Participants With Treatment Related Adverse Events. | Phase II | Grade 3 or Higher | 6 | participants | |
| Number of Participants With Treatment Related Adverse Events. | Phase II | Grade 4 or Higher | 3 | participants | |
| Number of Participants With Treatment Related Adverse Events. | Phase II | Grade 5 | 0 | participants | |
| Duration of Response Time | Phase II | 5.6 | 95% Confidence Interval 1.9 to 13.8 | Months | |
| Best Overall Response Over the First 6 Cycles of Treatment | Phase II | Complete Remission | 0 | participants | |
| Best Overall Response Over the First 6 Cycles of Treatment | Phase II | Partial Remission | 0 | participants | |
| Best Overall Response Over the First 6 Cycles of Treatment | Phase II | Clinical Improvement | 9 | participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Phase I | 12 | |
| Overall Study | STARTED | Phase II | 65 | |
| Overall Study | COMPLETED | Phase I | 12 | |
| Overall Study | COMPLETED | Phase II | 65 | |
| Overall Study | NOT COMPLETED | Phase I | 0 | |
| Overall Study | NOT COMPLETED | Phase II | 0 |
Source ClinicalTrials.gov
Adverse events52
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Hemoglobin decreased | Blood and lymphatic system disorders | Phase II | 53 | 65 | 214 |
| other | Left ventricular dysfunction | Cardiac disorders | Phase II | 1 | 65 | 1 |
| other | Hypothyroidism | Endocrine disorders | Phase II | 1 | 65 | 1 |
| other | Constipation | Gastrointestinal disorders | Phase II | 1 | 65 | 1 |
| other | Diarrhea | Gastrointestinal disorders | Phase II | 10 | 65 | 19 |
| other | Nausea | Gastrointestinal disorders | Phase II | 9 | 65 | 16 |
| other | Vomiting | Gastrointestinal disorders | Phase II | 3 | 65 | 4 |
| other | Edema limbs | General disorders | Phase II | 1 | 65 | 1 |
| other | Fatigue | General disorders | Phase II | 65 | 65 | 477 |
| other | Localized edema | General disorders | Phase II | 1 | 65 | 1 |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase II | ||
| Total, other adverse events | Phase II | 65 | 65 |
| Total, serious adverse events | Phase II | 19 | 65 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA015083 | Mayo Clinic Comprehensive Cancer Center Support Grant | WILLMAN, CHERYL LYNN | MAYO CLINIC ROCHESTER | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00669578
GET https://conductscience.org/api/trials/v1/NCT00669578/events?page=2