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Hydroxychloroquine for Cancer
Phase 1
Waitlist Available
Led By Sukeshi Patel Arora, MD
Research Sponsored by Sukeshi Patel
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This study is an open label non randomized study of hydroxychloroquine (HCQ) with histone deacetylase (HDAC) inhibitor Vorinostat in patients with advanced solid tumors to determine the maximum tolerated dose (MTD) and to evaluate the safety and antitumor activity of this drug combination.
Eligible Conditions
- Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum tolerated dose (MTD) of Hydroxychloroquine (HCQ) in combination with Vorinostat in patients with advanced solid tumors
Secondary outcome measures
To evaluate the antitumor activity of HCQ in combination with Vorinostat as determined by response rate and progression free survival (exploratory)
To evaluate the safety and tolerability of HCQ in combination with Vorinostat in this patient population as determined by toxicity profile, incidence and rating according to NCI/CTC v3.0 criteria.
Side effects data
From 2016 Phase 3 trial • 217 Patients • NCT0205725013%
Upper respiratory tract infection
6%
Neutropenia
6%
Sinusitis
5%
Alanine aminotransferase increased
5%
Urinary tract infection
4%
Injection site erythema
4%
Accidental overdose
4%
Bronchitis
3%
Injection site pruritus
2%
Thrombocytopenia
2%
Nasopharyngitis
2%
Contusion
1%
Arthralgia
1%
Anaemia
1%
Lumbar spinal stenosis
1%
Leukopenia
1%
Coronary artery occlusion
1%
Wolff-Parkinson-White syndrome
1%
Transient ischaemic attack
1%
Vertebrobasilar insufficiency
1%
Chronic obstructive pulmonary disease
1%
Small intestinal obstruction
1%
Nephrolithiasis
1%
Cataract
1%
Thrombophlebitis superficial
1%
Vomiting
1%
Endometrial hyperplasia
1%
Traumatic arthritis
1%
Hypertension
1%
Pneumonia
1%
Pancreatic carcinoma metastatic
1%
Osteoarthritis
1%
Rheumatoid lung
1%
Pharyngitis
1%
Femoral neck fracture
100%
80%
60%
40%
20%
0%
Study treatment Arm
Sarilumab 150 mg by PFS (Extension Phase)
Sarilumab 150 mg by AID (AID Assessment Phase)
Sarilumab 150 mg by PFS (AID Assessment Phase)
Sarilumab 200 mg by PFS (AID Assessment Phase)
Sarilumab 200 mg by AID (AID Assessment Phase)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Hydroxychloroquine and VorinostatExperimental Treatment2 Interventions
Oral administration of Vorinostat will be begin on Cycle 1 Day 1 at 300mg and will be continued daily and HCQ will be administered starting on Day 2 of Cycle 1 and both will be continued daily thereafter until progression of disease or unacceptable toxicity develops.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hydroxychloroquine
2017
Completed Phase 4
~5360
Vorinostat
2014
Completed Phase 3
~1600
Find a Location
Who is running the clinical trial?
Sukeshi PatelLead Sponsor
The University of Texas Health Science Center at San AntonioLead Sponsor
452 Previous Clinical Trials
91,338 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,891 Previous Clinical Trials
5,060,349 Total Patients Enrolled
Frequently Asked Questions
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