Study of the Pan-DAC Inhibitor AR-42 and Pazopanib in Advanced Sarcoma and Kidney Cancer
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|ClinicalTrials.gov Identifier: NCT02795819|
Recruitment Status : Terminated (Study drug no longer being clinically developed by manufacturer)
First Posted : June 10, 2016
Last Update Posted : April 3, 2019
|Condition or disease||Intervention/treatment||Phase|
|Renal Cell Carcinoma Soft Tissue Sarcoma Metastatic Disease||Drug: AR-42 Drug: Pazopanib||Phase 1|
This study is a single-arm, open-label, phase 1 trial to determine the RP2Ds of AR-42 and pazopanib when given in combination to patients with advanced Renal Cell Carcinoma (RCC) or Soft Tissue Sarcoma (STS). Eligible patients will have recurrent, unresectable, or metastatic RCC or STS for which pazopanib is an appropriate therapy.
AR-42 will be taken orally once per day on 3 non-consecutive days each week during the first 3 weeks of each 4-week cycle. Pazopanib will be taken by mouth once daily continuously during each cycle.
A modified 3+3 dose-escalation design will be followed until the maximum tolerated doses (MTDs) have been determined. Additional patients will be enrolled until a total of 12 patients have been treated at the MTDs. The maximum number of patients needed is 51 with an expected sample size of 29-35 patients enrolled over a period of about 15-35 months.
Correlative studies will be conducted using samples of tumor that were archived following the most recent surgery or biopsy.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 1 Study of the Pan-DAC Inhibitor AR-42 and Pazopanib in Advanced Soft Tissue Sarcoma and Renal Cell Carcinoma|
|Study Start Date :||July 8, 2016|
|Actual Primary Completion Date :||November 24, 2016|
|Actual Study Completion Date :||March 14, 2019|
Experimental: Pazopanib + AR42
AR-42 tablets will be taken orally once per day on 3 non-consecutive days during the first 3 weeks of each 4-week cycle. If treatment must be interrupted during the cycle, the cycle may be extended.
Pazopanib tablets will be taken orally once daily continuously during each 4-week treatment cycle. There are no scheduled breaks in pazopanib therapy.
Other Name: Votrient
- The recommended phase 2 doses (RP2Ds) of AR-42 and pazopanib when given in combination. [ Time Frame: 1 month ]To determine the recommended phase 2 doses (RP2Ds) for AR-42 and pazopanib that are the same as or less than the maximum tolerated doses (MTDs). The dose-limiting toxicity (DLT) evaluation period will be the first treatment cycle. Patients must have taken a minimum of 6 AR-42 doses and a minimum of 21 pazopanib doses during cycle 1 to be considered evaluable for DLT, if DLT has not been observed at the delivered dose. Patients' treatment dose level, dose modification, evaluability for DLT, and DLTs will be listed and summarized by basic descriptive statistics such as frequency and proportion. The maximum tolerated dose(MTDs)/recommended phase 2 doses (RP2Ds) will be found based on the criteria in the protocol.
- Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment, AR-42 and pazopanib combination. [ Time Frame: 5 months ]The safety and toxicity of AR-42 and pazopanib when given in combination. Adverse Events (AEs) characterized and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI CTCAE v4.0) to determine the safety and toxicity of the combination of AR-42 and pazopanib. All AEs regardless of grade will be recorded from the beginning of the study procedures through 30 days following the end of study treatment.
- The antitumor effects of the AR-42 and pazopanib treatment regimen in patients with advanced Renal Cell Carcinoma (RCC) or Soft Tissue Sarcoma (STS). [ Time Frame: 5 months ]Tumor response based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). The clinical response (complete response [CR] + partial response[PR]) rate will be calculated along with its 95% confidence interval.
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): NCT02795819
|United States, Virginia|
|Virginia Commonwealth University/Massey Cancer Center|
|Richmond, Virginia, United States, 23298|
|Principal Investigator:||Andrew S Poklepovic, MD||Massey Cancer Center|