MedTrace Logo

Oral Immunomodulatory Tyrosine Kinase Inhibitor in Patients With Locally Advanced or Metastatic Solid Tumors

NCT03454243 · Status: TERMINATED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2019-04-25

No results posted yet for this study

Summary

This is a first-in-human, open label, multicenter, dose escalation study of RXDX-106 in patients with locally advanced or metastatic solid tumors, who have no available therapy likely to convey clinical benefit.

This study will examine the safety, tolerability, pharmacokinetics (PK), pharmacodynamics and preliminary efficacy of RXDX 106.

Conditions

  • Advanced or Metastatic Solid Tumors

Interventions

DRUG

RXDX-106

Patients will receive continuous daily oral doses of RXDX-106 in 21 day cycles. To determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D), study drug will be administered in an escalated fashion starting at dose of 10 mg/day and will proceed at the dose levels prespecified by the dose escalation schema. Once daily dosing for RXDX-106 will initially be tested. However, other dosing schedules (eg, every other day, weight based, etc) may be tested based on safety and PK data to optimize drug exposure.

Sponsors & Collaborators

Principal Investigators

  • Pratik S. Multani, MD, MS · Chief Medical Officer, Ignyta, Inc.

  • Sandra Pierina D'Angelo, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-15
Primary Completion
2018-06-05
Completion
2018-06-05
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT03454243 on ClinicalTrials.gov