Clinical trial · Interventional
CC-5013 in Treating Patients With Cancer That Has Not Responded to Previous Therapy
A Multidose Phase I Study of Oral CC5013, a Thalidomide Derivative, in Patients With Refractory Metastatic Cancer
- 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-5013 may stop the growth of cancer by stopping blood flow to the tumor. PURPOSE: Phase I trial to study the effectiveness of CC-5013 in treating patients who have solid tumors and/or lymphoma that did not respond to previous therapy.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Small Intestine Cancer | Small Intestinal Carcinoma | ALIAS | 0.90 |
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| lenalidomide | Drug | Lenalidomide | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed refractory solid tumor and/or lymphoma * No brain metastases or primary CNS malignancies PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * More than 3 months Hematopoietic: * Granulocyte count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin normal * ALT and AST less than 2.5 times normal Renal: * Creatinine no greater than 1.5 mg/dL OR * Creatinine clearance greater than 60 mL/min Cardiovascular: * No unstable or newly diagnosed angina pectoris * No myocardial infarction within the past 6 months * No New York Heart Association class II, III, or IV congestive heart failure Pulmonary: * No chronic obstructive lung disease requiring oxygen therapy Other: * No uncontrolled seizures * No concurrent acute critical illness * No serious untreated infection * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 2 months after study participation PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 4 weeks since prior biologic therapy Chemotherapy: * At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas, mitomycin, or carboplatin) * No concurrent cytotoxic chemotherapy Endocrine therapy: * At least 4 weeks since prior hormonal therapy * Concurrent luteinizing hormone-releasing hormone agonist required in patients with prostate cancer unless prior orchiectomy has been performed Radiotherapy: * At least 4 weeks since prior radiotherapy Surgery: * See Endocrine therapy * Prior surgery allowed Other: * Recovered from prior therapy * No concurrent anticonvulsants (e.g., phenobarbital, phenytoin, or carbamazepine) * No concurrent rifampin * No concurrent grapefruit juice
References
Publications (2)
- BACKGROUNDTohnya TM, Hwang K, Lepper ER, Fine HA, Dahut WL, Venitz J, Sparreboom A, Figg WD. Determination of CC-5013, an analogue of thalidomide, in human plasma by liquid chromatography-mass spectrometry. J Chromatogr B Analyt Technol Biomed Life Sci. 2004 Nov 25;811(2):135-41. doi: 10.1016/j.jchromb.2004.08.022. PMID 15522712
- RESULTDahut WL, Aragon-Ching JB, Woo S, Tohnya TM, Gulley JL, Arlen PM, Wright JJ, Ventiz J, Figg WD. Phase I study of oral lenalidomide in patients with refractory metastatic cancer. J Clin Pharmacol. 2009 Jun;49(6):650-60. doi: 10.1177/0091270009335001. PMID 19451403