Hydroxychloroquine + Vorinostat in Advanced Solid Tumors
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|ClinicalTrials.gov Identifier: NCT01023737|
Recruitment Status : Active, not recruiting
First Posted : December 2, 2009
Last Update Posted : August 14, 2018
|Condition or disease||Intervention/treatment||Phase|
|Malignant Solid Tumour||Drug: Hydroxychloroquine Drug: Vorinostat||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||72 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Inhibition of Autophagy in Solid Tumors: A Phase I Pharmacokinetic and Pharmacodynamic Study of Hydroxychloroquine in Combination With the HDAC Inhibitor Vorinostat for the Treatment of Patients With Advanced Solid Tumors With an Expansion Study in Advanced Renal and Colorectal Cancer|
|Study Start Date :||November 2009|
|Estimated Primary Completion Date :||July 2019|
|Estimated Study Completion Date :||September 2020|
Experimental: Hydroxychloroquine and Vorinostat
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.
The 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.
Other Name: HCQ
Oral 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.
Other Name: Suberoylanilide Hydroxamic Acid
- Maximum tolerated dose (MTD) of Hydroxychloroquine (HCQ) in combination with Vorinostat in patients with advanced solid tumors [ Time Frame: 6+ months, MTD is assessed during the 1st cycle ]
- 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. [ Time Frame: 1 year ]
- To evaluate the antitumor activity of HCQ in combination with Vorinostat as determined by response rate and progression free survival (exploratory) [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01023737
|United States, Texas|
|Cancer Therapy & Research Center University of Texas Health Science Center San Antonio|
|San Antonio, Texas, United States, 78229|
|Principal Investigator:||Sukeshi Patel Arora, MD||University of Texas Health Science Center San Antonio|