Clinical trial · Interventional
CC-4047 in Treating Patients With Advanced Solid Tumors That Did Not Respond to Treatment
A Phase I, Open-Label Study to Determine the Maximum Tolerated Dose (MTD) and to Evaluate the Safety Profile of CC-4047 in Subjects With Advanced Solid Tumors
NCT00482521CI-TRIAL-00007904completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: CC-4047 may stop the growth of tumor cells by blocking blood flow to the tumor. PURPOSE: This phase I trial is studying the side effects and best dose of CC-4047 in treating patients with advanced solid tumors that did not respond to treatment.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CC-4047 | Drug | Pomalidomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CC-4047
- interventionNames
- Drug: CC-4047
Primary outcomes (2)
- measure
- Maximum tolerated dose
- timeFrame
- after initial 28 day cycle
- description
- To determine the maximum tolerated dose (MTD) of daily CC-4047 in an initial 28-day cycle (21 days of CC-4047 followed by 7 days of no therapy) in subjects with advanced solid tumors (Cohort A).
- measure
- Dose-limiting toxicity
- timeFrame
- Courses repeat every 28 days for up to 24 months in the absence of unacceptable toxicity.
Secondary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed advanced solid tumor * Refractory disease * Patients must have been offered and refused OR received and failed prior treatment with all standard or approved therapies for the malignancy * Measurable or evaluable disease as confirmed by radiographic or clinical evidence * No curative therapy available PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Life expectancy ≥ 3 months * ANC \> 1,500/mm³ * Platelet count \> 75,000/mm³ * Hemoglobin ≥ 9.0 g/dL * Creatinine ≤ 2.0 mg/dL * AST and ALT \< 3 times upper limit of normal * Not pregnant * No nursing during and for ≥ 28 days after completion of study treatment * Two negative pregnancy tests required * Fertile women must use effective double-method contraception for ≥ 28 days before, during, and for ≥ 28 days after completion of study treatment * Men must use a latex condom during sexual contact with fertile females during and for ≥ 28 days after completion of study treatment, even if a prior successful vasectomy was performed * Stable neurological exam * No serious medical condition or psychiatric illness that would preclude study participation * No prior desquamating rash or allergic reaction ≥ grade 2 while taking thalidomide, lenalidomide, or structurally related compounds * No peripheral neuropathy ≥ grade 2 * No active infection * No uncontrolled hyper- or hypocalcemia, glycosemia, or thyroidism PRIOR CONCURRENT THERAPY: * No prior CC-4047 * More than 28 days since prior cytotoxic chemotherapy (42 days for nitrosoureas) * At least 14 days since prior therapeutic radiotherapy * More than 14 days since prior thalidomide, lenalidomide, or structurally related compounds * More than 14 days since prior biological response modifier therapy * Concurrent radiotherapy to treat pain associated with existing bone lesions during the extension phase of the study allowed provided \< 10% of bone marrow is irradiated * Concurrent systemic steroids for control of CNS primary tumor and/or metastases symptoms allowed provided dose is stable or decreasing AND patient is also taking low-dose aspirin and/or other platelet-active, anti-thrombotic medication during and for 30 days after completion of study treatment * No other concurrent chemotherapy or immunotherapy * No other concurrent investigational agents * No concurrent hematopoietic growth factors during the treatment phase of the study * No other concurrent anticancer agents
References
Publications (0)
Data not yet available
No reference posted for this study.