Abstract | OBJECTIVES: METHODS: Patients with rMPC received 175 mg/m ganetespib intravenously once weekly for 3 weeks in 4-week cycles. Primary endpoint was disease control rate at 8 weeks, with a goal of 70%. Secondary endpoints were progression-free survival, overall survival, and safety. Simon's 2-stage design was used to assess futility and efficacy. Ganetespib was considered inactive if ≤8 patients among the first 15 treated had disease control after 8 weeks of treatment. RESULTS: Fourteen patients were treated on study. Grade 3 treatment-related toxicities were diarrhea, abdominal pain, fatigue, nausea, vomiting, and hyponatremia. Disease control rate at 8 weeks was 28.6%, and median progression-free survival and overall survival were 1.58 months and 4.57 months, respectively. Early stopping rules for lack of clinical efficacy led to study closure. CONCLUSIONS:
|
Authors | Dana B Cardin, Ramya Thota, Laura W Goff, Jordan D Berlin, Clyde M Jones, Gregory D Ayers, Jennifer G Whisenant, Emily Chan |
Journal | American journal of clinical oncology
(Am J Clin Oncol)
Vol. 41
Issue 8
Pg. 772-776
(08 2018)
ISSN: 1537-453X [Electronic] United States |
PMID | 28301350
(Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)
|
Chemical References |
|
Topics |
- Adult
- Aged
- Carcinoma, Pancreatic Ductal
(drug therapy, secondary)
- Drug Resistance, Neoplasm
- Female
- Follow-Up Studies
- Humans
- Lymphatic Metastasis
- Male
- Middle Aged
- Pancreatic Neoplasms
(drug therapy, pathology)
- Prognosis
- Salvage Therapy
- Survival Rate
- Triazoles
(therapeutic use)
|