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
|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.
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|