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Hydroxychloroquine

Phase 4FDA approved

Malignant Solid Tumour | Small molecule | Oncology |Merck & Company, Inc.|Trials Updated: Feb 13, 2023

Hydroxychloroquine development status

FDA approval on record Jan 14, 2022 as Sovuna
Approval holderNovitium Pharma
ApplicationNDA214581
Highest phase Phase 4 run by University of Alabama at Birmingham (NCT00259610)
Phase scored for MRKPhase 1
Registered trials 22 across 19 sponsors since Mar 2008

Hydroxychloroquine target and mechanism

ModalitySmall molecule

Also known as HCQ

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment72

FDA Designations

No designations recorded

Hydroxychloroquine clinical trials

Hydroxychloroquine · 1 trial · 1 indication

Phase 1 1
NCT01023737Hydroxychloroquine + Vorinostat in Advanced Solid TumorsMalignant Solid Tumour
COMPLETED72 Analytics
PHASE1COMPLETED
Hydroxychloroquine + Vorinostat in Advanced Solid Tumors
Malignant Solid Tumour
NCT0102373772
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Study Endpoints

Primary Endpoints

Maximum tolerated dose (MTD) of Hydroxychloroquine (HCQ) in combination with Vorinostat in patients with advanced solid tumors
6+ months, MTD is assessed during the 1st cycle

Secondary Endpoints

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.
1 year
To evaluate the antitumor activity of HCQ in combination with Vorinostat as determined by response rate and progression free survival (exploratory)
1 year
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Hydroxychloroquine and VorinostatEXPERIMENTALOral 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.

Interventions

NameTypeDescription
HydroxychloroquineDRUGThe HCQ study dose levels are defined as 400mg/day, 600mg/day, 800mg/day and 1000mg/day (oral dosing)during the phase I MTD determination. HCQ will be administered starting on Day 2 of Cycle 1 and will be continued daily thereafter until progression of disease or unacceptable toxicity develops.
VorinostatDRUGOral administration of Vorinostat will be begin on Cycle 1 Day 1 at 300mg and will be continued daily thereafter until progression of disease or unacceptable toxicity develops.
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Eligibility Criteria

Age Range16 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Patients must be at least 16 years of age * Patients must have a histologically confirmed non-hematological malignancy. Patients must have received and failed standard treatment for their malignancy; patients for whom no standard treatment is available will also be eligible. *...

Countries:United States
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