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Antisense Oligonucleotides

MEDI4736 + AZD9150/AZD5069 for Head & Neck Cancer

Q: In what cases is AZD9150 commonly prescribed?

<p>AZD9150 is applied to combat unresectable stage three non-<a href="https://www.withpower.com/clinical-trials/small-cell-lung-cancer">small cell lung cancer</a>, as well as providing aid for the initial treatment of metastatic ureteral carcinoma and advanced directives.</p>

Phase 1 & 2

Waitlist Available

Led By Dr David Hong, MD

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

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

Must have

Has an Eastern Cooperative Oncology Group (ECOG) PS score of 0 or 1

Arms B1-B6: Has undergone 1-3 previous regimens of cytoreductive chemo-therapies

Timeline

Screening 3 weeks

Treatment Varies

Follow Up throughout the study, up to 3.3 years

Awards & highlights

Study Summary

This trial is designed to study the safety and effectiveness of a new drug in people with a certain medical condition. It is split into two parts, with the first part focusing on safety and the second part focusing on effectiveness.

Who is the study for?

Adults with advanced solid tumors or relapsed metastatic squamous cell carcinoma of the head and neck, who have tried ≤3 previous cancer treatments (or none for certain arms), can join. They must be in good physical condition (ECOG PS 0 or 1) with proper organ function and measurable disease. Women of childbearing age and men with partners of childbearing potential must use effective birth control.Check my eligibility

What is being tested?

The trial is testing MEDI4736 combined with either AZD9150 or AZD5069, plus tremelimumab in some cases, to treat advanced cancers. It's a two-part study: Part A finds safe doses; Part B expands on those doses to further assess safety and effectiveness.See study design

What are the potential side effects?

Potential side effects include immune system reactions that may cause inflammation in various organs, infusion-related reactions, fatigue, digestive issues like diarrhea or colitis, blood disorders such as anemia or clotting problems, increased risk of infections due to immune suppression.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or restricted in physically strenuous activity but can do light work.

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I have had 1 to 3 rounds of chemotherapy to reduce my tumor size.

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I have had 3 or fewer previous cancer treatments.

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My cancer does not respond to standard treatments or no treatment exists.

Select...

My prostate cancer is resistant to hormonal therapy.

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My head or neck cancer cannot be cured with surgery or radiation.

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My cancer can be measured and fits certain size criteria.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ throughout the study, up to 3.3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~throughout the study, up to 3.3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and throughout the study, up to 3.3 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Part A: AZD5069 With Durvalumab MTDs (Maximum Tolerated Dose) or Recommended Doses for Dose-expansion

Part A: Danvatirsen With Durvalumab MTDs (Maximum Tolerated Dose) or Recommended Doses for Dose-expansion

Part A: Safety and Tolerability in Terms of Adverse Events

+1 more

Secondary outcome measures

Part A and B: AZD5069 AUC0-12h at Lead in Day -7

Part A and B: AZD5069 AUCss at Cycle 2 Day 1

Part A and B: AZD5069 Cmax at Lead in Day -7

+20 more

Side effects data

From 2015 Phase 1 trial • 58 Patients • NCT01839604

67%

Aspartate aminotransferase increased

50%

Platelet count decreased

50%

Alanine aminotransferase increased

33%

Rash

33%

Gamma-glutamylytransferase increased

33%

Hypertension

17%

Hypoalbuminaemia

17%

Pyrexia

17%

Dyspepsia

17%

Productive cough

17%

Dysphonia

17%

Decreased apetite

17%

Upper respiratory tract infection

17%

White blod cell count decreased

17%

Dyspnoea

17%

Insomnia

17%

Constipation

17%

Diarrhoea

17%

Haemoptysis

17%

Flank Pain

100%

80%

60%

40%

20%

Study treatment Arm

1.5 mg/kg

2 mg/kg

2.5 mg/kg

3 mg/kg

AZD9150 1mg/kg

Trial Design

15Treatment groups

Experimental Treatment

Group I: Part B8: AZD9150 (every other week)+MEDI4736: naive 1LExperimental Treatment2 Interventions

Patients in Arm B8 will be evaluated for efficacy until disease progression and then followed up for safety and survival

Group II: Part B7: AZD9150+MEDI4736: naiive 1LExperimental Treatment2 Interventions

Patients in Arm B7 will be evaluated for efficacy until disease progression and then followed up for safety and survival

Group III: Part B6:AZD5069 in naiive patientsExperimental Treatment1 Intervention

Patients in arm B6 will be evaluated for efficacy until disease progression and then allowed to receive additional MEDI4736 and followed for safety and survival

Group IV: Part B5: AZD9150 in naiive patientsExperimental Treatment1 Intervention

Patients in arm B5 will be evaluated for efficacy until disease progression and then allowed to receive additional MEDI4736 and followed for safety and survival

Group V: Part B4:AZD5069+MEDI4736:naiive patientsExperimental Treatment2 Interventions

Patients in arm B4 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.

Group VI: Part B3: AZD9150+MED4736:naiive 2LExperimental Treatment2 Interventions

Patients in arm B3 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.

Group VII: Part B2:AZD5069+MEDI4736:PDL1 pretreatedExperimental Treatment2 Interventions

Patients in arm B2 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.

Group VIII: Part B1:AZD9150+MEDI4736:PDL1 pretreatedExperimental Treatment2 Interventions

Patients in arm B1 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.

Group IX: Part A7: AZD5069/MEDI4736Experimental Treatment2 Interventions

Patients allocated in cohort of arm A7 (AZD5069/MEDI4736) will be evaluated for safety, PK and PD.

Group X: Part A6: AZD9150/MEDI4736Experimental Treatment2 Interventions

Patients allocated in cohort of arm A6 (AZD9150/MEDI4736) will be evaluated for safety, PK and PD.

Group XI: Part A5: AZD5069/Treme/MEDI4736Experimental Treatment3 Interventions

Patients allocated in cohort of arm A5 (AZD5069/treme/MEDI4736) will be evaluated for DLT and MTD.

Group XII: Part A4: AZD9150/Treme/MEDI4736Experimental Treatment3 Interventions

Patients allocated in cohort of arm A4 (AZD9150/treme/MEDI4736) will be evaluated for DLT and MTD

Group XIII: Part A3: AZD5069/MEDI4736Experimental Treatment2 Interventions

Patients allocated in cohort of arm A3 (AZD5069/MEDI4736) will be evaluated for DLT and viability as alternate dosing option for Phase 2 studies

Group XIV: Part A2: AZD5069 / MEDI4736Experimental Treatment2 Interventions

Patients allocated in cohort of arm A2 (AZD5069/MEDI4736 will be evaluated for DLT until an MTD is achieved.

Group XV: Part A1: AZD9150 / MEDI4736Experimental Treatment2 Interventions

Patients allocated in cohort of arm A1 (AZD9150/MEDI4736 will be evaluated for DLT until an MTD is achieved.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

AZD9150

2018

Completed Phase 1

~120

MEDI4736

2016

Completed Phase 3

~5560

AZD5069

2010

Completed Phase 2

~1640

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor

4,259 Previous Clinical Trials

288,593,562 Total Patients Enrolled

MedImmune LLCIndustry Sponsor

347 Previous Clinical Trials

793,569 Total Patients Enrolled

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

Media Library

AZD5069 (Antisense Oligonucleotides) Clinical Trial Eligibility Overview. Trial Name: NCT02499328 — Phase 1 & 2

Squamous Cell Carcinoma Research Study Groups: Part B7: AZD9150+MEDI4736: naiive 1L, Part B6:AZD5069 in naiive patients, Part A2: AZD5069 / MEDI4736, Part B2:AZD5069+MEDI4736:PDL1 pretreated, Part A4: AZD9150/Treme/MEDI4736, Part A3: AZD5069/MEDI4736, Part A6: AZD9150/MEDI4736, Part B8: AZD9150 (every other week)+MEDI4736: naive 1L, Part B4:AZD5069+MEDI4736:naiive patients, Part B5: AZD9150 in naiive patients, Part A5: AZD5069/Treme/MEDI4736, Part A7: AZD5069/MEDI4736, Part B1:AZD9150+MEDI4736:PDL1 pretreated, Part B3: AZD9150+MED4736:naiive 2L, Part A1: AZD9150 / MEDI4736

Squamous Cell Carcinoma Clinical Trial 2023: AZD5069 Highlights & Side Effects. Trial Name: NCT02499328 — Phase 1 & 2

AZD5069 (Antisense Oligonucleotides) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02499328 — Phase 1 & 2

Frequently Asked Questions

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

Is this medical research open to those over 35 years of age?

"This trial is open to those aged between 18 and 130. For minors, there are 85 trials they can participate in while the elderly (65+) can apply for 2993 studies."

Answered by AI

How many healthcare facilities are currently conducting this research program?

"The patient recruitment process is live across 21 sites, ranging from Fort Wayne to Whittier and Los Angeles. To reduce travel demands associated with the trial, please select the location closest to you when enrolling."

Answered by AI

Is enrollment being actively pursued for this clinical trial?

"Clinicaltrials.gov confirms that this particular trial, initially posted on August 6th 2015, is not presently recruiting participants. On the other hand, there are 3016 clinical trials actively enrolling patients right now."

Answered by AI

Has this sort of investigation been conducted previously or is it a pioneering effort?

"Presently, there are 340 trials for the drug AZD9150 spanning across 1327 cities in 58 countries. The earliest survey concerning this medication was held by AstraZeneca back in 2007 with 37 participants and concluded Phase 2 of its clinical trial phase. Following that initial study, 134 more studies have been conducted since then."

Answered by AI

In what cases is AZD9150 commonly prescribed?

"AZD9150 is applied to combat unresectable stage three non-small cell lung cancer, as well as providing aid for the initial treatment of metastatic ureteral carcinoma and advanced directives."

Answered by AI

Is it possible to partake in this exploration?

"This clinical trial is searching for approximately 340 volunteers between the ages of 18 and 130 that have carcinoma."

Answered by AI

Are there any additional research projects involving AZD9150?

"The pharmaceutical AZD9150 was initially evaluated in 2007 at Research Site. To date, 134 experiments have been concluded and 340 are currently ongoing—especially within the city of Fort Wayne, Indiana."

Answered by AI

What is the ultimate capacity of participants for this clinical trial?

"At present, this clinical trial is not recruiting patients. Although it was initially posted on August 6th 2015 and last edited October 3rd 2022, other studies are available for those seeking a medical study - of which there are 2676 trials currently enrolling participants with carcinoma and 340 trials admitting individuals to AZD9150."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study to Assess MEDI4736 With Either AZD9150 or AZD5069 in Advanced Solid Tumors & Relapsed Metastatic Squamous Cell Carcinoma of Head & Neck

2015. "Study to Assess MEDI4736 With Either AZD9150 or AZD5069 in Advanced Solid Tumors & Relapsed Metastatic Squamous Cell Carcinoma of Head & Neck". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02499328.

All > Squamous Cell Carcinoma