A Phase I Study of AR-67 (7-t-butyldimethylsilyl-10-hydroxycamptothecin) Given on Days 1, 4 8, 12 & 15 of an Every 21-day Cycle in Adult Patients With Refractory or Metastatic Solid Malignancies
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|ClinicalTrials.gov Identifier: NCT01202370|
Recruitment Status : Completed
First Posted : September 15, 2010
Last Update Posted : August 14, 2013
|Condition or disease||Intervention/treatment||Phase|
|Solid Malignancies||Drug: 7-t-butyldimethylsilyl-10-hydroxycamptothecin||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of AR-67 (7-t-butyldimethylsilyl-10-hydroxycamptothecin) Given on Days 1, 4 8, 12 & 15 of an Every 21-day Cycle in Adult Patients With Refractory or Metastatic Solid Malignancies|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||July 2011|
|Actual Study Completion Date :||July 2011|
Phase 1 study
IV Over 1 hour Days 1, 4, 8, 12 & 15 of a 21 day cycle (7.5 mg/m^2).
Other Name: AR-67
- To evaluate the feasibility of obtaining two serial tumor biopsies and plasma pharmacokinetics for the determination of AR-67 half life in tumor and plasma during day 1 of AR-67 treatment given on days 1, 4, 8, 12 and 15 of an every 21-day cycle. [ Time Frame: Cycle 1 days 1 and 2 ]
- Toxicities [ Time Frame: Days 1, 4, 8, 12 and 15 of an every 21-day cycle ]To document all toxicities of AR-67 after intravenous (IV) administration on days 1, 4, 8, 12 and 15 of an every 21-day cycle to adults with recurrent or refractory solid tumors in which standard therapies are not effective.
- Feasibility for testing topoisomerase-I and γ-H2AX in tumor tissue [ Time Frame: Cycle 1 days 1 and 2 ]To determine the feasibility for testing the expression of topoisomerase-I and γ-H2AX in tumor tissue biopsies using immunohistochemical techniques and western blot assays.
- Efficacy [ Time Frame: Days 1, 4 , 8, 12 and 15 of a 21 day cycle ]To collect efficacy data for these subjects using radiographic assessment of tumor response by RECIST 1.1.
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): NCT01202370
|United States, Kentucky|
|Markey Cancer Center, University of Kentucky|
|Lexington, Kentucky, United States, 40536|
|Principal Investigator:||Susanne M Arnold, MD||Lucille P. Markey Cancer Center at University of Kentucky|