AT13387 in Adults With Refractory Solid Tumors
Completed · Phase 1
Conditions studied: Solid Tumors, Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT01246102
- Run by
- National Cancer Institute (NCI)
- People needed
- 31
- Starts
- 2010-11-19
- Expected to finish
- 2017-10-27
- Last updated by the study team
- 2018-07-05
Who can join
Age: 18 and older, up to 120. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- Patients with known brain metastases or carcinomatous meningitis are excluded from this clinical trial, with the exception of patients whose brain metastatic disease status has remained stable for greater than or equal to 2 months after treatment of the brain metastases, without steroids or anti-seizure medications. These patients may be enrolled at the discretion of the principal investigator.
- Patients with clinically significant intercurrent illnesses, including but not limited to, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- QTc > 450 msec for men and > 470 msec for women.
- HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for PK interactions with AT13387.
- Pregnant women are ineligible because the effects of AT13387 on the developing human fetus are unknown.
- Exclude patients with active gastrointestinal bleeding or an event of gastrointestinal bleeding within a week of starting treatment.
- INCLUSION OF WOMEN AND MINORITIES:
- Both men and women, and members of all races and ethnic groups, are eligible for this trial.
Where it is running
- National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
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