← Back to Search

Small Molecule Drug

Adagrasib + Palbociclib for Solid Tumors

Phase 1
Waitlist Available
Research Sponsored by Mirati Therapeutics Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Unresectable or metastatic disease.
Histologically confirmed diagnosis of a solid tumor malignancy with KRAS G12C mutation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

Study Summary

This trial will study a new KRAS cancer treatment to see if it is safe and effective.

Who is the study for?
This trial is for adults with advanced solid tumors that have a specific mutation called KRAS G12C. Participants must not have any curative treatment options available and should have adequate organ function. They can't join if they have another active cancer, had severe side effects from similar treatments before, or conditions affecting drug absorption.Check my eligibility
What is being tested?
The study tests the combination of two drugs: Adagrasib (MRTX849) and Palbociclib on patients with advanced solid tumors harboring the KRAS G12C mutation to assess safety and effectiveness.See study design
What are the potential side effects?
Potential side effects may include digestive issues, liver problems due to altered organ function, fatigue, blood cell count changes leading to increased infection risk or bleeding complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My cancer cannot be removed by surgery or has spread.
Select...
My cancer has a specific KRAS G12C mutation.
Select...
There are no treatments that can cure my condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 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
Characterize the number of patients with treatment emergent adverse events of the combination regimen in patients with advanced solid tumor malignancies with KRAS G12C mutation.
Establish Maximum Tolerated Dose
Evaluate Pharmacokinetics of the combination regimen
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Dose ExpansionExperimental Treatment2 Interventions
Expansion cohorts may be implemented to ensure sufficient safety experience, pharmacokinetic data and early evidence of clinical activity of MRTX in combination with palbociclib.
Group II: Dose EscalationExperimental Treatment2 Interventions
Dose escalation of MRTX849 and palbociclib to determine maximum tolerated dose in combination.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MRTX849
2021
Completed Phase 1
~10
Palbociclib
2017
Completed Phase 3
~3760

Find a Location

Who is running the clinical trial?

Mirati Therapeutics Inc.Lead Sponsor
70 Previous Clinical Trials
8,244 Total Patients Enrolled

Media Library

Solid Tumors Clinical Trial 2023: MRTX849 Highlights & Side Effects. Trial Name: NCT05178888 — Phase 1

Frequently Asked Questions

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

Are there any vacant positions available for participants in this experiment?

"This medical trial is no longer recruiting participants. It was initially posted on February 1st, 2022 and the most recent update came out on October 26th, 2022. For those seeking other studies in this field, there are currently 2502 trials actively recruiting patients with cancer and 138 related to MRTX849 that need volunteers."

Answered by AI

How many participants is the clinical trial currently accommodating?

"Unfortunately, this experiment is not open for recruitment at the moment. It was initially published on February 1st 2022 and underwent its last amendment on October 26th 2022. If you're looking to join other clinical trials, there are currently 2502 studies actively recruiting cancer patients and 138 research projects searching for participants of MRTX849 treatments."

Answered by AI

What therapeutic uses has MRTX849 been approved for?

"MRTX849 is a common treatment for breast cancer and can be used to also address malignant neoplasms, postmenopausal conditions, as well as advanced directives."

Answered by AI

Has MRTX849 been given the stamp of approval by the U.S. Food and Drug Administration?

"Our team at Power graded MRTX849's safety a 1 due to the limited information available about both its efficacy and risk profile - this is only a Phase 1 trial."

Answered by AI

How many facilities are currently overseeing this clinical trial?

"At present, this medical research is recruiting from a total of 4 sites. These are located in Orlando, San Antonio and Houston as well as other nearby centres. To reduce the burden on participants, we recommend selecting the site closest to your residence when enrolling."

Answered by AI

Can you please provide information on prior research projects involving MRTX849?

"MRTX849 was initially researched at Unimed Medical Institute in 2012, with a total of 75 trials concluded. Presently, 138 additional clinical studies are underway that mainly take place in the city of Orlando, Florida."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Adagrasib in Combination With Palbociclib in Patients With Advanced Solid Tumors (KRYSTAL-16)
2022. "Adagrasib in Combination With Palbociclib in Patients With Advanced Solid Tumors (KRYSTAL-16)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05178888.
~3 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top