Abstract | BACKGROUND: METHODS: During the escalation phase, lenalidomide (days 1-21) and sorafenib (days 1-28) were given orally once daily at the following respective doses: level 1 (10 mg, 200 mg); level 2 (10 mg, 400 mg); level 3 (20 mg, 400 mg); and level 4 (25 mg, 400 mg) (1 cycle = 28 days). A "3 + 3" study design was used. RESULTS: Forty-one patients were treated (median age: 50 years). The most common diagnoses were adenoid cystic carcinoma (N = 9), ovarian adenocarcinoma (N = 7), and melanoma (N = 6); 142 cycles (median: 3) were administered. No dose-limiting toxicities were noted. The maximum tested dose (dose level 4) was used in the expansion phase. Grade 3-4 treatment-related toxicities were neutropenia, thrombocytopenia, skin rash, and thromboembolism. Of 38 patients who were evaluable for response, stable disease (SD) was noted in 53 % of patients (SD ≥6 months: 16 %). Tumor types with SD ≥ 6 months were as follows: ocular melanoma, 2/2 (100 %); other melanoma, 1/4 (25 %); adenoid cystic carcinoma, 2/9 (22 %); and ovarian cancer, 1/6 (17 %). The median progression-free survival duration was 3.5 months (95 % CI, 1.9-5.0), and the median overall survival duration was 12.3 months (95 % CI, 10.1-14.5). CONCLUSIONS:
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Authors | Prasanth Ganesan, Sarina Piha-Paul, Aung Naing, Gerald Falchook, Jennifer Wheler, Siqing Fu, David S Hong, Razelle Kurzrock, Filip Janku, Shell Laday, Agop Y Bedikian, Merrill Kies, Robert A Wolff, Apostolia M Tsimberidou |
Journal | Investigational new drugs
(Invest New Drugs)
Vol. 32
Issue 2
Pg. 279-86
(Apr 2014)
ISSN: 1573-0646 [Electronic] United States |
PMID | 23756764
(Publication Type: Clinical Trial, Phase I, Journal Article, Research Support, Non-U.S. Gov't)
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Chemical References |
- Angiogenesis Inhibitors
- Immunologic Factors
- Phenylurea Compounds
- Protein Kinase Inhibitors
- Niacinamide
- Thalidomide
- Sorafenib
- raf Kinases
- Lenalidomide
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Topics |
- Adult
- Aged
- Angiogenesis Inhibitors
(administration & dosage, adverse effects)
- Antineoplastic Combined Chemotherapy Protocols
(administration & dosage, adverse effects)
- Disease-Free Survival
- Female
- Humans
- Immunologic Factors
(administration & dosage, adverse effects)
- Lenalidomide
- Male
- Maximum Tolerated Dose
- Middle Aged
- Neoplasms
(drug therapy)
- Niacinamide
(administration & dosage, adverse effects, analogs & derivatives)
- Phenylurea Compounds
(administration & dosage, adverse effects)
- Protein Kinase Inhibitors
(administration & dosage, adverse effects)
- Sorafenib
- Thalidomide
(administration & dosage, adverse effects, analogs & derivatives)
- Young Adult
- raf Kinases
(antagonists & inhibitors)
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