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Hormone Therapy

AZD4635 for Non-Small Cell Lung Cancer

Phase 1
Waitlist Available
Research Sponsored by AstraZeneca
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 samples will be collected at pre-specified time points for up to one-week following a single-dose of azd4635 (cycle 0). the multiple-dose pk sampling will commence with cycle 1 day 1
Awards & highlights

Study Summary

This trial is testing the safety and effectiveness of a new drug, AZD4635, for treating patients with advanced solid tumors. The maximum tolerated dose will be determined in patients and expansion cohorts will assess safety and preliminary anti-tumor activity.

Eligible Conditions
  • Solid Tumors
  • Non-Small Cell Lung Cancer
  • Prostate Cancer
  • Colorectal Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~tumour response will be assessed 6 weeks after the start of treatment and then every 8 weeks; after 18 months, assessments will be every 12 weeks.
This trial's timeline: 3 weeks for screening, Varies for treatment, and tumour response will be assessed 6 weeks after the start of treatment and then every 8 weeks; after 18 months, assessments will be every 12 weeks. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The incidence of Dose-Limiting Toxicities (DLTs) in patients receiving AZD4635 in combination with durvalumab.
The incidence of Dose-Limiting Toxicities (DLTs) in patients receiving AZD4635 in combination with either abiraterone acetate or enzalutamide.
The incidence of Dose-Limiting Toxicities (DLTs) in patients receiving AZD4635 monotherapy orally.
+1 more
Secondary outcome measures
Amount of AZD4635 excreted unchanged in urine (Ae) after single-dose administration in Cycle 0
Apparent plasma clearance (CL/F) after single-dose administration of AZD4635 in Cycle 0
Apparent plasma clearance at steady state (CLss/F) following multiple-doses on Cycle 1 Day 15 in monotherapy arms and Cycle 1 Day 1 and Cycle 3 Day 15 in combination therapy arms.
+19 more

Side effects data

From 2023 Phase 2 trial • 59 Patients • NCT04089553
45%
Nausea
24%
Fatigue
21%
Decreased appetite
17%
Blood creatinine increased
14%
Urinary tract infection
14%
Constipation
14%
Diarrhoea
14%
Vomiting
14%
Dizziness
10%
Blood alkaline phosphatase increased
10%
Anaemia
10%
Muscular weakness
10%
Oedema peripheral
10%
Insomnia
10%
Abdominal pain
10%
Back pain
7%
Chills
7%
Peripheral sensory neuropathy
7%
Muscle spasms
7%
Confusional state
7%
Hypoxia
7%
Pain
3%
Localised oedema
3%
Skin infection
3%
Tooth infection
3%
Aspartate aminotransferase increased
3%
Infusion site extravasation
3%
Cachexia
3%
Covid-19
3%
Hypertension
3%
Hallucination
3%
Hyperglycaemia
3%
Non-cardiac chest pain
3%
Agitation
3%
Dyspnoea
3%
Lipase increased
3%
Hip fracture
3%
Rash maculo-papular
3%
Procedural pain
3%
Skin laceration
3%
Alanine aminotransferase increased
3%
Amylase increased
3%
Hyperkalaemia
3%
Hyperuricaemia
3%
Hypocalcaemia
3%
Hypokalaemia
3%
Musculoskeletal chest pain
3%
Myalgia
3%
Pain in extremity
3%
Tendonitis
3%
Spinal cord compression
3%
Transient ischaemic attack
3%
Acute kidney injury
3%
Haematuria
3%
Acute respiratory failure
3%
Pneumonitis
3%
Chronic kidney disease
3%
Cough
3%
Dermatitis
3%
Pruritus
3%
Gastrooesophageal reflux disease
3%
Haemorrhoidal haemorrhage
3%
Haemorrhoids
3%
Blood lactate dehydrogenase increased
3%
International normalised ratio increased
3%
Weight decreased
3%
Arthralgia
3%
Sinus tachycardia
3%
Hypoaesthesia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Module 1 (AZD4635 75 mg + Durvalumab 1500 mg)
Module 2 (AZD4635 50 / 75 mg + Oleclumab 1500 mg)

Trial Design

18Treatment groups
Experimental Treatment
Group I: Arm LExperimental Treatment1 Intervention
AZD4635 monotherapy as nanoparticle suspension in immunotherapy naïve patients with other solid tumours.
Group II: Arm KDExperimental Treatment2 Interventions
AZD4635 as nanoparticle suspension plus durvalumab in immunotherapy-naïve patients with colorectal carcinoma.
Group III: Arm KExperimental Treatment1 Intervention
AZD4635 monotherapy as nanoparticle suspension in immunotherapy naïve patients with colorectal carcinoma.
Group IV: Arm JExperimental Treatment1 Intervention
AZD4635 monotherapy as nanoparticle suspension in immunotherapy naïve patients with metastatic castration resistant prostate cancer. Patients will be allocated randomly (1:1) between Arms I and J.
Group V: Arm IExperimental Treatment2 Interventions
AZD4635 as nanoparticle suspension plus durvalumab in immunotherapy naïve patients with metastatic castration resistant prostate cancer. Patients will be allocated randomly (1:1) between Arms I and J.
Group VI: Arm HExperimental Treatment1 Intervention
AZD4635 monotherapy as nanoparticle suspension in patients post immunotherapy with other solid tumours.
Group VII: Arm GExperimental Treatment1 Intervention
AZD4635 monotherapy as nanoparticle suspension in patients post immunotherapy with non-small cell lung cancer. Patients will be allocated randomly (1:1) between Arms F and G.
Group VIII: Arm FExperimental Treatment2 Interventions
AZD4635 as nanoparticle suspension plus durvaluamb in patients post immunotherapy with non-small cell lung cancer. Patients will be allocated randomly (1:1) between Arms F and G.
Group IX: Arm EAExperimental Treatment2 Interventions
AZD4635 as nanoparticle suspension plus enzalutamide
Group X: Arm EExperimental Treatment2 Interventions
AZD4635 as nanoparticle suspension 100 mg QD plus durvalumab
Group XI: Arm DExperimental Treatment2 Interventions
AZD4635 as nanoparticle suspension 75 mg QD plus durvalumab
Group XII: Arm CCExperimental Treatment2 Interventions
AZD4635 capsule formulation 50 mg QD or 75 mg QD plus docetaxel. The pharmacokinetics of the single dose AZD4635 capsule formulation will be characterized on Cycle 1 Day 1 in Arm CC. Steady-state pharmacokinetics will be assessed on Cycle 1 Day 15. Cycles will be administered in 3-week cycles to assess the safety and dose-limiting toxicity (DLT). After Cycle 1, PKs will be collected on Day 1 of every even numbered cycle (Cycles 2, 4, and 6).
Group XIII: Arm CBExperimental Treatment3 Interventions
AZD4635 capsule formulation 50 mg QD or 75 mg QD plus durvalumab and oleclumab. The pharmacokinetics of AZD4635 capsule formulation will be characterized on Cycle 1, 2, and 4 (Day 1) in Arm CB. Steady-state pharmacokinetics will be assessed on Cycle 2 Day 15. Cycle 1 will be administered in a 3-week cycle to assess the safety and dose-limiting toxicity (DLT). PKs will also be collected on Day 1 of Cycles 3 and 5.
Group XIV: Arm CAExperimental Treatment1 Intervention
AZD4635 capsule formulation monotherapy 75 mg, 150 mg, and 200 mg QD. A lower dose of 125 mg or 100 mg may be given. The pharmacokinetics of the single dose AZD4635 capsule formulation will be characterized on Cycle 1 Day 1 in Arm CA. Steady-state pharmacokinetics will be assessed on Cycle 1 Day 15. Cycle 1 and Cycle 2 will be administered in 3-week cycles to assess the safety and dose-limiting toxicity (DLT). After Cycle 1, PKs will be collected on Day 1 of every even numbered cycle (Cycles 2, 4, and 6).
Group XV: Arm CExperimental Treatment1 Intervention
AZD4635 monotherapy as nanoparticle suspension 100 mg QD
Group XVI: Arm BExperimental Treatment1 Intervention
AZD4635 monotherapy as nanoparticle suspension 75 mg QD
Group XVII: Arm AAExperimental Treatment2 Interventions
AZD4635 as nanoparticle suspension plus abiraterone acetate
Group XVIII: Arm AExperimental Treatment1 Intervention
AZD4635 monotherapy as nanoparticle suspension 125 mg BID
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oleclumab
2015
Completed Phase 2
~880
Docetaxel
1995
Completed Phase 4
~5620
Enzalutamide
2014
Completed Phase 4
~2760
AZD4635
2016
Completed Phase 2
~440
Abiraterone Acetate
2015
Completed Phase 4
~1880
Durvalumab
2017
Completed Phase 2
~3870

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,265 Previous Clinical Trials
288,604,969 Total Patients Enrolled
Johanna Bendell, MDStudy ChairSCRI Development Innovations, LLC
10 Previous Clinical Trials
837 Total Patients Enrolled

Frequently Asked Questions

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

Could you elaborate on the protective measures for those utilizing AZD4635?

"There is restricted clinical data concerning AZD4635's efficacy and safety, earning it a score of 1."

Answered by AI

What are the desired outcomes of this experiment?

"The primary outcome of this 7 week-long clinical trial is the measurement of Dose Limiting Toxicities (DLTs) in patients administered AZD4635 combined with either abiraterone acetate or enzalutamide. Time to peak plasma concentration, extent of accumulation, and tumour response will serve as secondary measurements. To achieve these objectives intensive pharmacokinetic sampling alongside ECG matching are required for certain cohorts whilst sparse sample collection may be sufficient for others."

Answered by AI

What medical afflictions can be assuaged through the use of AZD4635?

"AZD4635 is mainly used to address malignant esophageal neoplasms, but can also be deployed for conditions like unresectable stage III non-small cell lung cancer and castration treatment."

Answered by AI

Who meets the criteria to be a viable participant in this clinical research?

"To take part in this research project, candidates must have a diagnosis of colorectal carcinoma and be aged between 18 and 130. Currently, the team is actively seeking 313 individuals to join their trial."

Answered by AI

Is this medical trial being conducted at multiple sites across the United States?

"Seventeen medical sites are currently enrolling patients in this clinical trial, including three hubs located in New york, Decatur and Lecanto. In order to reduce travel time, it is advised that prospective participants select the site closest to them."

Answered by AI

Is the age criteria for this clinical research including individuals over 50?

"This clinical trial welcomes participants aged 18 or older up to the age of 130."

Answered by AI

Could you please elucidate what past experiments have explored AZD4635?

"Currently, the clinical landscape of AZD4635 involves 798 different ongoing studies with a large portion (215) in Phase 3. The majority are located in Germantown, Tennessee; however, there are 44301 sites participating worldwide."

Answered by AI

What is the capacity of this clinical experiment in terms of recruited participants?

"Unfortunately, this research is no longer actively searching for participants. Initially posted on June 17th 2016 and last edited on November 10th 2022, the study has since closed its recruitment window. As an alternative, there are currently 7858 clinical trials recruiting patients with colorectal carcinoma and 798 studies looking for volunteers to take part in AZD4635 investigations."

Answered by AI

Are there any open slots to participate in the current research project?

"The data hosted on clinicaltrials.gov suggests that this research is no longer actively seeking patient involvement. Initially posted in June of 2016, it was last modified 11/10/2022; however, there are 8656 substitute studies currently enrolling participants."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Phase 1 Clinical Study of AZD4635 in Patients With Advanced Solid Malignancies
2016. "A Phase 1 Clinical Study of AZD4635 in Patients With Advanced Solid Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02740985.
~35 spots leftby Apr 2025
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