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AT13387 in Adults With Refractory Solid Tumors

NCT01246102 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2018-07-05

No results posted yet for this study

Summary

Background:

\- The experimental drug AT13387 has been shown to have some anticancer effects against tumor cells by blocking a protein that affects other proteins inside certain cancer cells, and helps to prevent the cancer cells from reproducing and spreading. AT13387 has not been tested in humans, and researchers are interested in investigating whether it can be used to treat solid tumors that have not responded to standard treatments.

Objectives:

\- To investigate the safety and effectiveness of AT13387 in individuals with solid tumors.

Eligibility:

\- Individuals at least 18 years of age who have solid tumors that have not responded to standard treatments.

Design:

* Participants will be screened with a physical examination and medical history, as well as blood tests and tumor imaging studies.
* AT13387 will be given in 28-day cycles of treatment. Participants will receive AT13387 twice a week (2 days in a row) for the first 3 weeks of the cycle, followed by a fourth week without the drug.
* Participants will have regular blood and urine samples, imaging studies, eye examinations, and tumor biopsies to monitor the effects of the treatment.
* Participants will continue treatment with AT13387 unless serious side effects develop or the tumor stops responding to treatment.

Conditions

Interventions

DRUG

AT13387

Treatment will be administered as a 1-hour IV infusion on 2 consecutive days of every week for 3 weeks, followed by a 1-week period without drug administration.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Alice P Chen, M.D. · National Cancer Institute (NCI)

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-19
Primary Completion
2013-12-30
Completion
2017-10-27

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01246102 on ClinicalTrials.gov