NCT01877811

An Open-Label, Phase 1/1b, Single-Agent Study of RXDX-105 in Patients With Advanced Solid Tumors

Completed Phase 1 Last updated 24 April 2019

What this trial tests

Phase 1 trial testing RXDX-105 in Solid Tumors in 143 participants. Completed in 1 February 2019.

Timeline

1 June 2013

Primary endpoint
1 December 2018

1 February 2019

Quick facts

Lead sponsor	Hoffmann-La Roche
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	143
Start date	1 June 2013
Primary completion	1 December 2018
Estimated completion	1 February 2019
Sites	14 locations across United States

Drugs / interventions tested

• RXDX-105 — full drug profile →

Conditions studied

• Solid Tumors — all drugs for Solid Tumors →

Sponsor

Hoffmann-La Roche — full company profile →

Who can join

18 and older, any sex, with Solid Tumors. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Phase 1: Dose Limiting Toxicities
  Time frame: Approximately 12 months
  From signing of the informed consent up to approximately 12 months
• Phase 1: Occurrence of Adverse Events
  Time frame: Approximately 12 months
  From signing of the informed consent up to approximately 12 months
• Phase 1b: Occurrence of Adverse Events
  Time frame: Approximately 12 months
  To further assess the safety profile and tolerability of RXDX-105 at the RP2D

Sponsor's own description

This is a first-in-human, multicenter, open-label study consisting of 2 phases. Phase 1 is a dose escalation study of RXDX-105 (formerly known as CEP-32496) in patients with advanced solid tumors aimed at defining the recommended Phase 2 dose (RP2D) and schedule for administration. Phase 1b is a dose expansion in approximately 90 patients with advanced solid tumors with specific histologies and/or molecular alterations of interest. Patients in Phase 1b will be treated at the RP2D determined in Phase 1.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. New perspectives for targeting RAF kinase in human cancer.
   Karoulia Z, Gavathiotis E, Poulikakos PI. · · 2017 · cited 332× · PMID 28984291 · DOI 10.1038/nrc.2017.79
2. Targeting RET-driven cancers: lessons from evolving preclinical and clinical landscapes.
   Drilon A, Hu ZI, Lai GGY, Tan DSW. · · 2018 · cited 259× · PMID 29134959 · DOI 10.1038/nrclinonc.2017.175
3. Small molecule inhibitors targeting the cancers.
   Liu GH, Chen T, Zhang X, Ma XL, et al · · 2022 · cited 127× · PMID 36254250 · DOI 10.1002/mco2.181
4. A Phase I/Ib Trial of the VEGFR-Sparing Multikinase RET Inhibitor RXDX-105.
   Drilon A, Fu S, Patel MR, Fakih M, et al · · 2019 · cited 97× · PMID 30487236 · DOI 10.1158/2159-8290.cd-18-0839
5. RET fusions in a small subset of advanced colorectal cancers at risk of being neglected.
   Pietrantonio F, Di Nicolantonio F, Schrock AB, Lee J, et al · · 2018 · cited 84× · PMID 29538669 · DOI 10.1093/annonc/mdy090
6. Effects of BRAF mutations and BRAF inhibition on immune responses to melanoma.
   Ilieva KM, Correa I, Josephs DH, Karagiannis P, et al · · 2014 · cited 72× · PMID 25385327 · DOI 10.1158/1535-7163.mct-14-0290
7. RET signaling pathway and RET inhibitors in human cancer.
   Regua AT, Najjar M, Lo HW. · · 2022 · cited 68× · PMID 35957881 · DOI 10.3389/fonc.2022.932353
8. Analysis of Cell-Free DNA from 32,989 Advanced Cancers Reveals Novel Co-occurring Activating <i>RET</i> Alterations and Oncogenic Signaling Pathway Aberrations.
   Rich TA, Reckamp KL, Chae YK, Doebele RC, et al · · 2019 · cited 66× · PMID 31300450 · DOI 10.1158/1078-0432.ccr-18-4049