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Kinase Inhibitor

Drug Combinations for Colorectal Cancer

Phase 1
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
All patients must have a BRAF V600 mutation confirmed by local assessment.
Patients must have documented disease progression following, or are intolerant to, 1 or 2 lines of chemotherapy for advanced/metastatic disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 34 months
Awards & highlights

Study Summary

This trial is testing the safety and tolerability of different combinations of drugs in order to find the best doses and regimens for future studies.

Who is the study for?
Adults with advanced/metastatic BRAF V600 colorectal cancer who've had disease progression after 1-2 chemotherapy lines or are intolerant to them. Participants must be willing to undergo tumor biopsies and have a confirmed BRAF V600 mutation. Excluded are those with significant heart issues, gastrointestinal conditions affecting drug absorption, certain eye diseases, HIV, other active cancers (with exceptions), lung diseases, or pregnant/breastfeeding women.Check my eligibility
What is being tested?
The trial is testing combinations of drugs LXH254, Dabrafenib, Spartalizumab, Tislelizumab, TNO155, Trametinib and LTT462 in adults with specific colorectal cancer. It's an early-phase study aiming to find out the safest doses for future research by monitoring participants' reactions.See study design
What are the potential side effects?
Potential side effects may include typical reactions seen with cancer treatments such as nausea, fatigue, skin changes and increased risk of infections. Specific side effects will depend on the drug combination received but can also involve risks related to immune system responses or organ inflammation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My cancer has a BRAF V600 mutation.
Select...
My cancer has worsened after 1 or 2 chemotherapy treatments, or I couldn't tolerate the treatment.
Select...
My colon or rectum cancer cannot be surgically removed and has a specific mutation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~34 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 34 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose intensity
Frequency of dose interruptions
Frequency of dose reductions
+2 more
Secondary outcome measures
AUClast derived from Serum/plasma concentration of individual investigational drugs within combination treatments
AUCtau derived from Serum/plasma concentration of individual investigational drugs within combination treatments
Best overall response (BOR)
+7 more

Trial Design

7Treatment groups
Experimental Treatment
Group I: Dabrafenib + trametinib + TNO155 triplet arm 5Experimental Treatment3 Interventions
dose escalation to determine maximum tolerated dose (MTD)/ Recommended dose (RD) in adult patients with advanced or metastatic BRAF V600 colorectal cancer
Group II: Dabrafenib + LTT462 backbone arm 1Experimental Treatment2 Interventions
dose escalation to determine maximum tolerated dose (MTD)/ Recommended dose (RD) in adult patients with advanced or metastatic BRAF V600 colorectal cancer
Group III: Dabrafenib + LTT462 + trametinib triplet arm 1Experimental Treatment3 Interventions
dose escalation to determine maximum tolerated dose (MTD)/ Recommended dose (RD) in adult patients with advanced or metastatic BRAF V600 colorectal cancer
Group IV: Dabrafenib + LTT462 + spartalizumab triplet arm 4Experimental Treatment3 Interventions
dose escalation to determine maximum tolerated dose (MTD)/ Recommended dose (RD) in adult patients with advanced or metastatic BRAF V600 colorectal cancer - Arm is closed for further enrollment.
Group V: Dabrafenib + LTT462 + Tislelizumab triplet arm 6Experimental Treatment3 Interventions
dose escalation to determine maximum tolerated dose (MTD)/ Recommended dose (RD) in adult patients with advanced or metastatic BRAF V600 colorectal cancer
Group VI: Dabrafenib + LTT462 + TNO155 triplet arm 3Experimental Treatment3 Interventions
dose escalation to determine maximum tolerated dose (MTD)/ Recommended dose (RD) in adult patients with advanced or metastatic BRAF V600 colorectal cancer
Group VII: Dabrafenib + LTT462 + LXH254 triplet arm 2Experimental Treatment3 Interventions
dose escalation to determine maximum tolerated dose (MTD)/ Recommended dose (RD) in adult patients with advanced or metastatic BRAF V600 colorectal cancer - Arm is closed for further enrollment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dabrafenib
2011
Completed Phase 3
~4120
Spartalizumab
2020
Completed Phase 2
~280
Tislelizumab
2018
Completed Phase 3
~4260
Trametinib
2014
Completed Phase 2
~1550

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,855 Previous Clinical Trials
4,197,228 Total Patients Enrolled

Media Library

Dabrafenib (Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04294160 — Phase 1
Colorectal Cancer Research Study Groups: Dabrafenib + LTT462 + trametinib triplet arm 1, Dabrafenib + LTT462 + LXH254 triplet arm 2, Dabrafenib + LTT462 + Tislelizumab triplet arm 6, Dabrafenib + LTT462 backbone arm 1, Dabrafenib + trametinib + TNO155 triplet arm 5, Dabrafenib + LTT462 + spartalizumab triplet arm 4, Dabrafenib + LTT462 + TNO155 triplet arm 3
Colorectal Cancer Clinical Trial 2023: Dabrafenib Highlights & Side Effects. Trial Name: NCT04294160 — Phase 1
Dabrafenib (Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04294160 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the main aims of this research endeavor?

"This 30 month long trial is monitoring the frequency of dose interruptions, while also evaluating preliminary anti-tumor activity with Disease control rate (DCR) and Progression free survival (PFS). Additionally, AUClast derived from Serum/plasma concentration will be measured to better understand the pharmacokinetics of each drug."

Answered by AI

What is the current status of Dabrafenib in terms of regulatory approval?

"As this is a preliminary Phase 1 medical trial, the safety of Dabrafenib has been rated a 1 due to its limited clinical data regarding effectiveness and security."

Answered by AI

How many locations are presently conducting this trial?

"This trial is operating out of UCLA Medical Center Santa Monica Location in Los Angeles, California; Sarah Cannon Research Institute SC in Nashville, Tennessee; University of California at Los Angeles Santa Monica Location Boston, Massachusetts and 6 other sites."

Answered by AI

Are there any related investigations that have been conducted utilizing Dabrafenib?

"The inaugural research on dabrafenib was conducted in 2011 by UCLA School of Medicine. There have been 115 concluded studies, with 118 more presently underway; the majority of these experiments are taking place in Los Angeles."

Answered by AI

How many participants are currently involved in this research endeavor?

"To carry out the experiment, Novartis Pharmaceuticals needs to recruit 350 suitable candidates. As such, two participating medical centers have been identified - UCLA Medical Center Santa Monica Site in Los Angeles and Sarah Cannon Research Institute SC in Nashville."

Answered by AI

Is enrollment for this examination still open?

"According to the official clinicaltrials.gov registry, this trial is actively recruiting applicants with a start date of July 22nd 2020 and an amended listing updated on June 7th 2022."

Answered by AI

Is this an original clinical trial?

"Since 2011, Novartis Pharmaceuticals has sponsored research into dabrafenib. The initial investigation included 185 participants and the drug was successfully approved for Phase 1 in 2011. Presently, the medication is being assessed in 118 trials taking place across 1166 cities and 41 nations."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of Select Drug Combinations in Adult Patients With Advanced/Metastatic BRAF V600 Colorectal Cancer
2020. "A Study of Select Drug Combinations in Adult Patients With Advanced/Metastatic BRAF V600 Colorectal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04294160.
All > Colorectal Cancer Los Angeles
~10 spots leftby Sep 2024
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