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About
The purpose of this study is to determine the safety and tolerability of XL765. XL765 is a new chemical entity that inhibits the kinases PI3K and mTOR. In preclinical studies, inactivation of PI3K has been shown to inhibit growth and induce apoptosis (programmed cell death) in tumor cells, whereas inactivation of mTOR has been shown to inhibit the growth of tumor cells.
Enrollment
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Inclusion criteria
The subject has a histologically confirmed metastatic or unresectable solid tumor for which standard curative or palliative measures do not exist or are no longer effective, and there are no therapies known to prolong survival.
The subject has disease that is assessable by tumor marker, physical, or radiologic means.
The subject is at least 18 years old.
The subject's weight is at lease 40 kg.
The subject has an Eastern Cooperative Oncology Group performance status of 0 - 2.
The subject has adequate organ and bone marrow function.
The subject has fasting plasma glucose < 120 mg/dL at screening.
for subjects who are to be enrolled into the Expanded MTD Cohort and Lower-Dose Tumor Genetic Alteration Subjects:
The subject is capable of understanding the protocol and has signed the informed consent.
Sexually active subjects (male and female) must use medically acceptable methods of contraception during the course of the study.
Female subjects of childbearing potential must have a negative serum pregnancy test at screening.
If the subject has received more than 3 prior regimens of cytotoxic chemotherapy, more than 2 biologic regimens, or more than 3000 cGy to >25% of his or her bone marrow, the sponsor must determine subject suitability before enrollment.
The subject has had no other diagnosis of malignancy (unless non-melanoma skin cancer, in situ carcinoma of the cervix, or a malignancy diagnosed ≥ 2 years ago, and has had no evidence of disease for 2 years prior to screening for this study.)
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
83 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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