Safety, Tolerability and Pharmacokinetics of Quisinostat, a Histone Deacetylase Inhibitor, in Combination With Chemotherapy
Open-label Multicenter Multiple Ascending Dose Study to Evaluate Safety, Tolerability and Pharmacokinetics of Quisinostat, a Histone Deacetylase Inhibitor, in Combination With Gemcitabine + Cisplatin Chemotherapy (Second Line for Patients With Non-small Cell Lung Cancer) or Paclitaxel + Carboplatin Chemotherapy (Second Line for Patients With Non-small-cell Lung Cancer, Second and Subsequent Lines for Patients With Epithelial Ovarian Cancer)
This date has not been verified as actual or estimated.
Primary Completion
December 2015
Actual (reported)
Study Completion
January 2016
Actual (reported)
Brief Summary
Quisinostat besides its own efficacy, which can potentially lead to better results of polychemotherapy and increase the mean time to progression, it may be demonstrated that Quisinostat leads to sustained tumor sensitivity to platinum drugs. In this study safety and tolerability of multiple administrations of Quisinostat in doses ranging from 8 mg to 12 mg combined with standard backbone chemotherapy in patients with non-small cell lung cancer (second line) and ovarian cancer (second and subsequent lines) will be investigated.
Registry Overview
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Recruitment status
completed
Actual enrollment (reported)
51 participants
Study completion date
January 2016
Actual (reported)
Listed locations
1 countries · 6 sites
Trial Relationships
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Related Scientific Literature
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Study Timeline
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
Study Start
August 2013
Date type not reported
This date has not been verified as actual or estimated.
safety and tolerability of Quisinostat based on number of patients with treatment -related AEs assessed by CTCAE v4.0, number of patients with abnormal laboratory values and instrumental tests (ECG) that are related to treatment
22 weeks
Other Outcomes (2)
Peak Plasma Concentration (Cmax) of Quisinostat
Day 1, Day 7
Area under the Quisinostat plasma concentration versus time curve (AUC)
Day 1, Day 7
Study Arms (7)
Quisinostat 8 mg & Paclitaxel & Carboplatin
EXPERIMENTAL
Quisinostat 8 mg capsule every other day and Paclitaxel 175 mg/m2 on Day 7 of every 3-weeks course and Carboplatin (mg/ml х min) х \[GFR (ml/min) + 25\] on Day 7 of every 3-weeks course up to 6 cycles
Quisinostat 10 mg capsule every other day and Paclitaxel 175 mg/m2 on Day 7 of every 3-weeks course and Carboplatin (mg/ml х min) х \[GFR (ml/min) + 25\] on Day 7 of every 3-weeks course up to 6 cycles
Quisinostat 12 mg capsule every other day and Paclitaxel 175 mg/m2 on Day 7 of every 3-weeks course and Carboplatin (mg/ml х min) х \[GFR (ml/min) + 25\] on Day 7 of every 3-weeks course up to 6 cycles
Quisinostat 8 mg capsule every other day and Gemcitabine 1000 mg/m2 on Day 7 and on Day 14 of every 3-weeks course and Cisplatin 75 mg/m2 on Day 7 of every 3-weeks course up to 6 cycles
Quisinostat 10 mg capsule every other day and Gemcitabine 1000 mg/m2 on Day 7 and on Day 14 of every 3-weeks course and Cisplatin 75 mg/m2 on Day 7 of every 3-weeks course up to 6 cycles
Quisinostat 12 mg capsule every other day and Gemcitabine 1000 mg/m2 on Day 7 and on Day 14 of every 3-weeks course and Cisplatin 75 mg/m2 on Day 7 of every 3-weeks course up to 6 cycles
Quisinostat 12 mg capsule every other day and Gemcitabine 1250 mg/m2 on Day 7 and on Day 14 of every 3-weeks course and Cisplatin 75 mg/m2 on Day 7 of every 3-weeks course up to 6 cycles
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The value of left ventricular ejection fraction, as determined by echocardiography data, more than 50%
Patient's ability to carry out visits and study procedures and to comply with the protocol
Requirements to laboratory parameters determined below:
Complete blood count: Absolute neutrophil count:
Platelets:
Haemoglobin: ≥ 1500/mm3 (1.5 x 109 cells/l)
/mm3 (100 x 109 cells/l)
g/dl
Liver function: Total bilirubin:
aspartate aminotransferase (AST) and alanine aminotransferase (ALT): ≤ 1.5-fold of the upper limit of normal (ULN)
≤ 2.5--fold of ULN or ≤ 5.0-fold of ULN in case of metastases in liver Kidney function: GRF (by Cockcroft-Gault equation) \> 50 ml/min
The expected survival time not less than 6 months
Women and men of childbearing potential (not sterile or in menopause less than 2 years) must be practicing an effective method of birth control starting from the screening period, during the study and 6 months after the last administration of the investigational product. Effective methods include use a condom or diaphragm (barrier method) with spermicide.
+6 more criteria
You may not qualify if:
Presence of clinical and/or radiological signs of metastases in the brain and meningeal structures (CNS);
Previous therapy with HDAC inhibitors
Any contraindications to the chemotherapy with Gemcitabine + Cisplatin or Paclitaxel + Carboplatin (in patients with lung cancer); contraindications to chemotherapy according to the standard chemotherapy combination scheme Paclitaxel + Carboplatin (in female patients with ovarian cancer);
Any contraindications to administration of glucocorticosteroids, antihistamine drugs, serotonin 5-HT3 receptor antagonists, aprepitant;
Any contraindications to forced rehydration and/or administration of forced diuresis (in case of lung cancer);
Conditions that require continuous use of oral anticoagulants, or clinically significant changes in blood coagulation parameters at screening (INR \> 1.5, aPTT\> 1.5 х ULN)
Conditions that require admission of prohibited drugs, or impossibility to replace those with allowed drugs in the study
Current infection or other systemic conditions constituting a contraindication to the intended chemotherapy;
Diseases of the digestive system which may infringe absorption of the investigational product (Crohn's disease, nonspecific ulcerative colitis, irritable bowel syndrome)
Myocardial infarction within 12 months before screening
Unstable angina within 12 months before screening
Congestive heart failure Class III or IV according to the New York Heart Association criteria (NYHA)
Clinically significant ventricular arrhythmia including ventricular tachycardia, ventricular fibrillation, history of cardiac arrest, atrioventricular block (Mobitz II or III), use of cardiostimulator
QTc interval \> 450 ms in men or 470 ms in women (ECG) (calculated according to Fredericia formula), or a diagnosis of long QT syndrome
+9 more criteria
Contact the study team to confirm eligibility.
Lung Diseases
Respiratory Tract Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Ovarian Neoplasms
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
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Source: ClinicalTrials.gov.
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