Study of Intravenous RXDX-107 in Patients With Solid Tumors

Stopped early · Phase 1

Conditions studied: Solid Tumor

In brief

This is an open-label, Phase I/Ib, dose escalation study of intravenous RXDX-107 administered to subjects with advanced solid tumors. The study is designed to explore the safety, maximum tolerated dose (MTD), pharmacokinetics, pharmacodynamics, and preliminary clinical activity of RXDX-107 and to define a recommended Phase 2 dose (RP2D)

Key facts

Study ID

NCT02548390

Run by

Hoffmann-La Roche

People needed

70

Starts

2015-09-01

Expected to finish

2016-09-01

Last updated by the study team

2019-04-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Confirmed relapsed or refractory locally advanced or metastatic solid cancer for whom no standard therapy is considered appropriate, or for whom standard therapy is considered intolerable.
• >18 years of age.
• ECOG performance status of 0 or 1.
• Life expectancy of at least 3 months.
• Received the last dose of previous treatment / therapy before Day 1 of cycle 1:
• 28 days for cytotoxic chemotherapy, immunotherapy, whole brain radiotherapy, anticonvulsive therapy, stereotactic radiosurgery and major surgery
• 42 days for nitrosureas, mitomycin C, and liposomal anthracycline
• 14 days for non-cytotoxic cancer therapies and radiotherapy
• Recovered from all toxic effects (excluding alopecia) of any prior anti-cancer therapy to Grade ≤ 1 or to the baseline laboratory values.
• Adequate organ function and baseline laboratory values
• Women of childbearing potential must have a negative serum pregnancy
• Phase 1b: Patient must have measurable disease

You may not qualify if…

• Receiving other experimental therapy
• Known symptomatic brain mets or leptomeningeal involvement
• Myocardial infarction in the previous 12 weeks. Active ischemia or any other uncontrolled cardiac condition such as angina pectoris, significant cardiac arrhythmia requiring therapy, uncontrolled hypertension, or CHF.
• Another concurrent illness which would preclude study conduct and assessment, uncontrolled: medical condition, active infection, risk of bleeding, diabetes mellitus, or pulmonary disease, or alcoholic liver disease, or primary biliary cirrhosis.
• Malignancy within 3 years or active disease requiring treatment other than the target cancer. The exceptions are prostate cancer (Gleason grade < 6 with normalized PSA levels), treated in situ cervical, breast carcinoma, squamous or basal cell skin cancer.
• Any condition that may compromise the ability to give written informed consent or to comply with the study protocol.

Where it is running

• Florida Cancer Specialists — Sarasota, Florida, United States
• Johns Hopkins Medical Institute — Baltimore, Maryland, United States
• Tennessee Oncology, LLC — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.