MedTrace Logo

Study of Intravenous RXDX-107 in Patients With Solid Tumors

NCT02548390 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2019-04-25

No results posted yet for this study

Summary

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)

Conditions

Interventions

DRUG

RXDX-107

Subjects in this study will receive RXDX-107 intravenously at dose levels specified for their respective dose cohorts. Dosing will begin at 25 mg/m2 on Day 1 and Day 2 of a 28-day cycle and will escalate until the maximum tolerated dose (MTD) or (RP2D) is determined. An additional schedule of administration of RXDX-107 on Day 1 of a 28 day cycle may be assessed. Cycles will be repeated in four-week (28 day) intervals for up to 6 cycles or until progression of disease, unacceptable toxicity, or another discontinuation criterion is met.

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2016-09-30
Completion
2016-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT02548390 on ClinicalTrials.gov