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mTOR Inhibitor

TAK-228 for Kidney Cancer

Q: Has the FDA sanctioned TAK-228 for use?

Given the lack of clinical evidence supporting efficacy, TAK-228 received a score 2 on our team's safety scale.

Q: Are further participants being sought for this study?

Clinicaltrials.gov indicates that this clinical trial is no longer actively recruiting; it was first posted on the 1st of August 2017 and last updated on 16th May 2022. However, there are an abundance of other medical studies currently taking applications from patients- 2582 in total.

Q: Are there multiple sites offering this clinical research opportunity?

The University of <a href="https://www.withpower.com/clinical-trials/colorado">Colorado</a> <a href="https://www.withpower.com/clinical-trials/cancer">Cancer</a> Center in Aurora, the <a href="https://www.withpower.com/clinical-trials/massachusetts">Massachusetts</a> General Hospital located in Chicago, and the Dana Farber Cancer Institute situated in La Jolla are three hubs for this clinical trial. Additionally, eight other locations have been added to the list of participating sites.

Q: What are the expected outcomes of this research trial?

According to the trial sponsor, Calithera Biosciences Inc., the primary objective for this study is Overall Response Rate. Data around secondary outcomes such as Median Progression Free Survival and Median Overall Survival will also be collected by means of Imaging assessments every 8 weeks (2 cycles) over a maximum 14 month period. Additionally, Radiographic progression will be tracked using Response Evaluation Criteria In Solid Tumors Criteria 1.1 which looks at an increase in target lesion size or appearance of new lesions.. Lastly, overall survival (OS) of TAK-228 in previously treated metastatic RCC patients is another key metric

Phase 2

Waitlist Available

Led By Bradley McGregor, MD

Research Sponsored by Bradley A. McGregor, MD

Eligibility Criteria Checklist

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

Must have

Age ≥ 18 years

Documented pathologic diagnosis of RCC. All subtypes eligible including but not limited to clear cell, papillary, chromophobe, collecting duct carcinoma, medullary carcinoma, and unclassified categories. Sarcomatoid and rhabdoid differentiation are allowed

Timeline

Screening 3 weeks

Treatment Varies

Follow Up imaging assessments occurred every eight weeks (2 cycles) for response evaluation. the median number of cycles administered was 2 (range <1-15), thus participants were assessed up to ~14 months.

Awards & highlights

Study Summary

This trial is testing a drug, TAK-228, as a possible treatment for people with metastatic renal cell carcinoma.

Who is the study for?

Adults with metastatic renal cell carcinoma (RCC) who have previously been treated. Clear cell RCC patients must have tried at least one anti-angiogenic and one PD-1 pathway blocker, unless not suitable. Non-clear cell RCC patients need to have had any cancer therapy before. Participants must be in good physical condition, able to understand the study, consent to it, and use contraception if sexually active.Check my eligibility

What is being tested?

The trial is testing TAK-228 as a potential treatment for metastatic renal cell carcinoma. Patients will receive this drug to see how effective it is against their cancer after previous treatments.See study design

What are the potential side effects?

While specific side effects of TAK-228 are not listed here, similar drugs can cause issues like fatigue, nausea, increased risk of infections due to immune system suppression, liver problems, heart complications and possibly allergic reactions.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am 18 years old or older.

Select...

I have been diagnosed with renal cell carcinoma (RCC), regardless of the subtype.

Select...

I have non-clear cell cancer and have been treated with at least one cancer therapy.

Select...

My stored cancer tissue sample is of good quality for testing.

Select...

I can take care of myself and am up and about more than half of the day.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ imaging assessments occurred every eight weeks (2 cycles) for response evaluation. the median number of cycles administered was 2 (range <1-15), thus participants were assessed up to ~14 months.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~imaging assessments occurred every eight weeks (2 cycles) for response evaluation. the median number of cycles administered was 2 (range <1-15), thus participants were assessed up to ~14 months.

This trial's timeline: 3 weeks for screening, Varies for treatment, and imaging assessments occurred every eight weeks (2 cycles) for response evaluation. the median number of cycles administered was 2 (range <1-15), thus participants were assessed up to ~14 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

Best Overall Response Rate

Secondary outcome measures

Median Overall Survival

Median Progression Free Survival

Therapeutic procedure

Side effects data

From 2024 Phase 2 trial • 39 Patients • NCT03097328

68%

Nausea

63%

Fatigue

42%

Anorexia

39%

Constipation

34%

Vomiting

32%

Mucositis oral

26%

Cough

24%

Anemia

24%

Diarrhea

24%

Rash maculo-papular

21%

Back pain

18%

Pain

18%

Dyspnea

18%

Pain in extremity

18%

Hyperkalemia

16%

Creatinine increased

13%

Hyperglycemia

13%

Myalgia

13%

Pruritus

13%

Hypotension

11%

Edema limbs

11%

Headache

11%

Generalized muscle weakness

11%

Dehydration

11%

Hypothyroidism

11%

Sore throat

11%

Renal and urinary disorders - Other, specify

11%

Dry mouth

11%

Gastroesophageal reflux disease

Acute kidney injury

General disorders and administration site conditions - Other, specify

Chills

Non-cardiac chest pain

Insomnia

Gastrointestinal disorders - Other, specify

Urinary frequency

Platelet count decreased

Abdominal pain

Skin and subcutaneous tissue disorders - Other, specify

Hematuria

Hyponatremia

Dizziness

Cardiac disorders - Other, specify

Fever

Sinus tachycardia

Dysgeusia

Dyspepsia

Palmar-plantar erythrodysesthesia syndrome

Aspartate aminotransferase increased

Musculoskeletal and connective tissue disorder - Other, specify

Depression

Colitis

Hyperhidrosis

Hiccups

Proteinuria

Hypercalcemia

Alanine aminotransferase increased

Urinary tract infection

Cholesterol high

Upper respiratory infection

Tremor

Pneumonitis

Bone pain

Hematoma

Atrioventricular block first degree

Anal pain

Watering eyes

Vaginal infection

Investigations - Other, specify

Arthralgia

Hemoglobinuria

Stomach pain

Confusion

Sinusitis

Apnea

Endocrine disorders - Other, specify

Bruising

Tinnitus

Bullous dermatitis

Palpitations

Lymph node pain

Peripheral motor neuropathy

Tracheal fistula

Weight loss

Pleural effusion

Urinary retention

Chest pain - cardiac

Eye pain

Retinal detachment

Abdominal distension

Small intestinal obstruction

Toothache

Gait disturbance

Anxiety

Adrenal insufficiency

Epistaxis

Hyperparathyroidism

Vascular disorders - Other, specify

Memory impairment

Agitation

Delirium

Blood bilirubin increased

Fracture

Nail infection

Hypokalemia

Abdominal soft tissue necrosis

Hyperthyroidism

Bile duct stenosis

Metabolism and nutrition disorders - Other, specify

Hypertriglyceridemia

Dry skin

Nervous system disorders - Other, specify

Suicidal ideation

Urinary tract obstruction

Breast pain

Chronic kidney disease

Lymphocyte count decreased

Pulmonary fibrosis

Sinus bradycardia

Myocardial infarction

Leukocytosis

Duodenal hemorrhage

Buttock pain

Flank pain

Amnesia

Seizure

Surgical and medical procedures - Other, specify

Hypertension

Thromboembolic event

100%

80%

60%

40%

20%

Study treatment Arm

TAK-228

Trial Design

1Treatment groups

Experimental Treatment

Group I: TAK-228Experimental Treatment1 Intervention

TAK-228 will be taken orally on a weekly basis for 4 weeks per cycle Dosage will be determined by the study team

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

TAK-228

2013

Completed Phase 2

~170

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Calithera Biosciences, IncIndustry Sponsor

33 Previous Clinical Trials

1,982 Total Patients Enrolled

Bradley A. McGregor, MDLead Sponsor

2 Previous Clinical Trials

60 Total Patients Enrolled

Bradley A. McGregorLead Sponsor

2 Previous Clinical Trials

60 Total Patients Enrolled

Media Library

Kidney Cancer Clinical Trial 2023: TAK-228 Highlights & Side Effects. Trial Name: NCT03097328 — Phase 2

Frequently Asked Questions

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

Has the FDA sanctioned TAK-228 for use?

"Given the lack of clinical evidence supporting efficacy, TAK-228 received a score 2 on our team's safety scale."

Answered by AI

Are further participants being sought for this study?

"Clinicaltrials.gov indicates that this clinical trial is no longer actively recruiting; it was first posted on the 1st of August 2017 and last updated on 16th May 2022. However, there are an abundance of other medical studies currently taking applications from patients- 2582 in total."

Answered by AI

Are there multiple sites offering this clinical research opportunity?

"The University of Colorado Cancer Center in Aurora, the Massachusetts General Hospital located in Chicago, and the Dana Farber Cancer Institute situated in La Jolla are three hubs for this clinical trial. Additionally, eight other locations have been added to the list of participating sites."

Answered by AI

What are the expected outcomes of this research trial?

"According to the trial sponsor, Calithera Biosciences Inc., the primary objective for this study is Overall Response Rate. Data around secondary outcomes such as Median Progression Free Survival and Median Overall Survival will also be collected by means of Imaging assessments every 8 weeks (2 cycles) over a maximum 14 month period. Additionally, Radiographic progression will be tracked using Response Evaluation Criteria In Solid Tumors Criteria 1.1 which looks at an increase in target lesion size or appearance of new lesions.. Lastly, overall survival (OS) of TAK-228 in previously treated metastatic RCC patients is another key metric"

Answered by AI

Recent research and studies

JCO Precision OncologyJournal

Biomarker-based Phase II Study of Sapanisertib (TAK-228): An Mtorc1/2 Inhibitor in Patients with Refractory Metastatic Renal Cell Carcinoma

McGregor, Bradley A., Wanling Xie, Elio Adib, Walter M. Stadler, Yousef Zakharia, Aijai Alva, M. Dror Michaelson, et al.. 2022. “Biomarker-based Phase II Study of Sapanisertib (TAK-228): An Mtorc1/2 Inhibitor in Patients with Refractory Metastatic Renal Cell Carcinoma”. JCO Precision Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/po.21.00448.

clinicaltrials.govStudy

Study of TAK-228 In Patients With Previously Treated Metastatic Renal Cell Carcinoma

Bradley A. McGregor, MD 2017. "Study of TAK-228 In Patients With Previously Treated Metastatic Renal Cell Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03097328.