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A Phase II Multicentre, Open-Label, Proof-of-Concept Study of Tasquinimod in Hepatocellular, Ovarian, Renal Cell, and Gastric Cancers
- Source :
- Targeted oncology. 12(5)
- Publication Year :
- 2017
-
Abstract
- Background: \ud \ud Tasquinimod is a small molecule with immunomodulatory, anti-angiogenic, and anti-metastatic properties that targets the tumor microenvironment. This study aimed to obtain a clinical proof of concept that tasquinimod was active and tolerable in patients with advanced solid tumors.\ud \ud Patients and Methods: \ud \ud This early stopping design, open-label, proof-of-concept clinical trial evaluated the clinical activity of tasquinimod in four independent cohorts of patients with advanced hepatocellular (n = 53), ovarian (n = 55), renal cell (n = 38), and gastric (n = 21) cancers. Tasquinimod was given orally every day (0.5 mg/day for at least 2 weeks, with dose increase to 1 mg/day) until radiological progression according to Response Evaluation Criteria in Solid Tumor (RECIST) 1.1 criteria, intolerable toxicity, or patient withdrawal. The primary efficacy endpoint was progression-free survival (PFS) rate according to RECIST 1.1 by central assessment.\ud \ud Results: \ud \ud Interim futility analyses at 8 weeks (6 weeks for the gastric cancer cohort) found adequate clinical activity of tasquinimod only in the hepatocellular cohort and recruitment to the other three cohorts was stopped. PFS rates were 26.9% at 16 weeks, 7.3% at 24 weeks, 13.2% at 16 weeks, and 9.5% at 12 weeks, respectively, in hepatocellular, ovarian, renal cell, and gastric cancer cohorts. The pre-defined PFS threshold was not reached in the hepatocellular cancer cohort at the second stage of the trial. The most common treatment-related adverse events were fatigue (48.5%), nausea (34.1%), decreased appetite (31.7%), and vomiting (24.6%).\ud \ud Conclusions: \ud \ud This study failed to demonstrate clinical activity of tasquinimod in heavily pre-treated patients with advanced hepatocellular, ovarian, renal cell, and gastric cancer.\ud \ud Trial registration: \ud \ud NCT01743469.
- Subjects :
- 0301 basic medicine
Oncology
Male
Cancer Research
medicine.medical_specialty
Nausea
Antineoplastic Agents
Kaplan-Meier Estimate
Quinolones
Disease-Free Survival
Tasquinimod
03 medical and health sciences
0302 clinical medicine
Stomach Neoplasms
Internal medicine
Carcinoma
Medicine
Humans
Pharmacology (medical)
Stage (cooking)
Adverse effect
Ovarian Neoplasms
business.industry
Liver Neoplasms
Cancer
medicine.disease
Kidney Neoplasms
Surgery
Clinical trial
030104 developmental biology
030220 oncology & carcinogenesis
Cohort
Female
medicine.symptom
business
Subjects
Details
- ISSN :
- 1776260X and 17762596
- Volume :
- 12
- Issue :
- 5
- Database :
- OpenAIRE
- Journal :
- Targeted oncology
- Accession number :
- edsair.doi.dedup.....d3a84723353a4b7cbb4ad963b2b1c1ba