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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02137564
Other study ID # AMC-089
Secondary ID NCI-2014-00638AM
Status Withdrawn
Phase Phase 2
First received May 9, 2014
Last updated July 21, 2015
Start date July 2015
Est. completion date July 2015

Study information

Verified date July 2015
Source AIDS Malignancy Consortium
Contact n/a
Is FDA regulated No
Health authority United States: Federal GovernmentUnited States: Food and Drug AdministrationUnited States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

This phase II trial studies the effects, good and bad, of gamma secretase inhibitor PF-03084014 and to see how well it works in treating patients with acquired immune deficiency virus (AIDS)-associated Kaposi sarcoma. Gamma secretase inhibitor PF-03084014 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and may shrink the tumor.


Description:

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Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
gamma secretase inhibitor PF-03084014
Given PO
Other:
pharmacological study
Correlative studies
laboratory biomarker analysis
Correlative studies

Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
AIDS Malignancy Consortium National Cancer Institute (NCI), The EMMES Corporation

Outcome

Type Measure Description Time frame Safety issue
Primary Overall clinical response (PR and CR) The results of tumor evaluations will be tabulated. Binomial probabilities and their 95% confidence intervals will be used to estimate the response rates (i.e., overall response rate, partial response rate, complete response rate). Up to 28 days after completion of study treatment No
Primary Incidence of adverse events, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0) The results of the safety evaluation will be tabulated. The frequency of adverse events (AEs) and their severity will be tabulated to evaluated tolerance. Up to 28 days after completion of study treatment Yes
Secondary Levels of HIV virus load in plasma The log10 of the level measured at the end of therapy and the log10 of the level obtained at baseline will be calculated for each patient. Descriptive statistics (e.g., mean, standard deviation, minimum and maximum) will be calculated. If sufficient data are available, a paired t-test will be used to test the log10 virus load difference between the end of therapy and baseline. Up to 168 days No
Secondary CD4+ cell number The log10 of the level measured at day 22, at the end of therapy, and baseline will be calculated for each patient. Descriptive statistics (e.g., mean, standard deviation, minimum and maximum) will be calculated. If sufficient data are available, a paired t-test will be used to test the log10 CD4+ cell number difference between the end of therapy and baseline. Up to day 168 days No
Secondary Change in gene expression in tumor samples measured via reverse transcriptase polymerase chain reaction (RT-PCR) Latent and lytic gene expression values will be computed compared to housekeeping genes (e.g. glyceraldehyde-3-phosphate dehydrogenase [GAPDH]), and the ratio of values for each gene at day 8 compared to that at baseline computed for each patient. The median and range will be determined for these ratios. Wilcoxon signed rank test will be used to determine if the ratio is significantly different from 1.0. Baseline to up to day 8 No
Secondary Activation of Notch target genes in tumor samples, measured via RT-PCR Levels of expression of each gene at baseline and day 8 will be computed compared to housekeeping genes (e.g. GAPDH), and the ratio of values for each gene at day 8 compared to that at baseline computed for each patient. The median and range will be determined for these ratios. Wilcoxon signed rank test will be used to determine if the ratio is significantly different from 1.0. Baseline to up to day 8 No
Secondary Trough gamma secretase inhibitor PF-03084014 drug levels Analysis of variance will be used to assess the relationship between trough drug levels and the likelihood of response, the response duration, and time to progression. Analysis of variance will be used to assess the relationship between trough drug levels and the likelihood of grade 3 or higher toxicity. Up to day 22 No
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