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EGFR Inhibitor

Ixazomib for Solid Tumors

Phase 1

Waitlist Available

Led By David S. Hong, MD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 28 days

Awards & highlights

Study Summary

This trial is studying the combination of ixazomib and erlotinib to find the highest tolerable dose and to study the safety of the drugs in patients with advanced solid tumors.

Eligible Conditions

Solid Tumors

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 28 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~28 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Maximum Tolerated Dose (MTD) of Ixazomib and Erlotinib in Advanced Cancer Participants

Secondary outcome measures

Tumor Response of Ixazomib and Erlotinib in Participants with Non Small Cell Lung Cancer

Erlotinib

Side effects data

From 2021 Phase 4 trial • 45 Patients • NCT03416374

26%

Diarrhoea

23%

White blood cell count decreased

21%

Platelet count decreased

15%

Neutrophil count decreased

13%

Pneumonia

Rash

Anaemia

Constipation

Malaise

Pyrexia

Acute kidney injury

Nasopharyngitis

Influenza

Pneumonia bacterial

Tumour lysis syndrome

Febrile neutropenia

Prinzmetal angina

Bile duct stone

Gastroenteritis

Interstitial lung disease

Taste disorder

Enterocolitis

Duodenal ulcer

100%

80%

60%

40%

20%

Study treatment Arm

[KRd]; Carfilzomib + Lenalidomide + Dexamethasone Therapy

[Overall]; Combination Therapy + Ixazomib Therapy

[VRd]; Bortezomib + Lenalidomide + Dexamethasone Therapy

Trial Design

3Treatment groups

Experimental Treatment

Group I: Dose Expansion Group - Pancreatic Ductal AdenocarcinomaExperimental Treatment2 Interventions

Dose Expansion Phase : Participants take Ixazomib capsules by mouth on Days 1, 8, and 15 of each 28 day cycle at the maximum tolerated dose from Dose Escalation Phase. Participants take Erlotinib tablets by mouth on Days 1 - 28 of each 28 day cycle.

Group II: Dose Expansion Group - Non Small Cell Lung CancerExperimental Treatment2 Interventions

Group III: Dose Escalation Group - Ixazomib + ErlotinibExperimental Treatment2 Interventions

Dose Escalation Phase: Participants take Ixazomib capsules by mouth on Days 1, 8, and 15 of each 28 day cycle starting with Dose Level 1. Participants take Erlotinib tablets by mouth on Days 1 - 28 of each 28 day cycle.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ixazomib

2017

Completed Phase 4

~3370

Erlotinib

2011

Completed Phase 4

~2290

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,972 Previous Clinical Trials

1,787,312 Total Patients Enrolled

Millennium: The Takeda Oncology CompanyIndustry Sponsor

7 Previous Clinical Trials

185 Total Patients Enrolled

David S. Hong, MDPrincipal InvestigatorM.D. Anderson Cancer Center

14 Previous Clinical Trials

552 Total Patients Enrolled

Frequently Asked Questions

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

Are any new participants currently being accepted into this research initiative?

"Unfortunately, this study is not presently searching for candidates. First posted on March 6th 2017 and last updated October 20 2022, the trial has concluded its recruitment process for now. However, there are still over 2700 other clinical trials that need participants to join them right away."

Answered by AI

Has the Food and Drug Administration validated Ixazomib as a viable treatment?

"Due to a lack of data regarding safety and efficacy, Ixazomib is rated at 1 on our team's scale. This acknowledges the fact that this trial is still in its initial Phase 1 stage."

Answered by AI

In what type of ailments has Ixazomib shown to be particularly efficacious?

"Ixazomib is predominantly used to treat metastatic pancreatic cancer, but can also be prescribed as a primary therapy for pancreatic carcinoma and multiple myeloma."

Answered by AI

How many participants are being accepted into this medical research program?

"This clinical trial is not presently open for recruitment. The study was first listed on March 6th, 2017 and the latest update occured on October 20th of 2022. For those interested in alternative trials, 2584 unrelated studies are accepting patients with solid tumors while 117 other research projects have opened up to enrollees taking Ixazomib treatments."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of Ixazomib and Erlotinib in Solid Tumors

2017. "Study of Ixazomib and Erlotinib in Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02942095.