A Randomized Discontinuation Study of XL184 in Subjects With Advanced Solid Tumors
The purpose of this study is to determine whether or not XL184 demonstrates anti-tumor activity in selected tumor types under a randomized discontinuation trial (RDT) design. Subjects who have responded to study drug after 12 weeks of open-label XL184 administration will continue to take XL184. Subjects who are clearly progressing will discontinue study treatment and subjects who demonstrate stable disease will be randomized to either XL184 or placebo. For individual patients, once disease progression is observed, the blind will be broken and subjects who were randomized to placebo will be offered the option to receive open-label XL184. Subjects who progressed while taking XL184 will discontinue study treatment. Emerging data may support enrollment in an open-label, non-randomized expansion cohort (NRE). There will be NRE cohorts for prostate and ovarian cancers.
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- drug : Placebo
- drug : XL184
Phase: Phase 2
Ages Eligible For Study:
- The subject has a cytologically or histologically and radiologically confirmed, advanced, recurrent, or metastatic solid tumor of the nine types listed below: - Pancreatic Cancer - Castration-Resistant Prostate Cancer (CRPC) - Hepatocellular Carcinoma (HCC) - Gastric or Gastroesophageal Junction Cancer - Melanoma - Small Cell Lung Cancer (SCLC) - Ovarian cancer, primary peritoneal or fallopian tube carcinoma - Breast cancer that is one of the following subtypes: estrogen receptor positive breast cancer, estrogen receptor/progesterone receptor/HER2-negative (triple-negative), or inflammatory (regardless of receptor status) disease histology - Non-Small Cell Lung Cancer (NSCLC) - Certain requirements for prior therapies may apply - The subject has documented progressive disease at screening - Subjects having any tumor type of other than CRPC must have at least one lesion that is not within a previously irradiated field and is measurable on CT or MRI scan - The subject has recovered to baseline or CTCAE ? Grade 1 from toxicities related to prior treatment (some exceptions apply) - The subject is ? 18 years old on the day of consent - Tissue samples from archival or fresh tissue, or a tissue block of the subject's tumor - The subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - The subject has adequate organ function - The subject is capable of understanding and complying with the protocol requirements and has signed the informed consent document - Sexually active fertile subjects (male and female), and their partners, must agree to use medically accepted methods of contraception during the course of the study and for 3 months after the last dose of the study drug(s) - Female subjects of childbearing potential must have a negative pregnancy test at screening