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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must have at least 1 RECIST version 1.1 measurable lesion.
Adequate bone marrow, renal, and hepatic functions, as determined by the following laboratory parameters:
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upup to approximately 50 months
Awards & highlights
No Placebo-Only Group
Study Summary
This trial is studying TAK-500 to find out how well it works in treating adults with certain types of solid tumors that have spread or cannot be removed by surgery. TAK-500 will be given alone or with pembrolizumab and will be compared to standard of care.
Eligible Conditions
- Kidney Cancer
- Non-small Cell Lung Cancer (NSCLC)
- Mesothelioma
- Pancreatic Cancer
- Liver Cancer
- Breast Cancer
- Stomach Cancer
- Esophageal Cancer
- Nasopharyngeal Cancer
- Squamous Cell Carcinoma
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You have been diagnosed with advanced or spread-out tumors in certain areas of your body, such as the stomach, pancreas, liver, lung, head and neck, breast, kidney, or nasopharynx. You have already tried all standard treatments for your type of cancer, and either the treatments did not work or you had side effects that made it impossible to continue with them.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 50 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 50 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dose Escalation: Number of Participants Reporting one or More Serious Adverse Event (SAEs)
Dose Escalation: Number of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs)
Dose Escalation: Number of Participants With Dose Limiting Toxicities (DLTs)
+3 moreSecondary outcome measures
Dose Escalation and Dose Expansion: AUCinf: Area Under the Serum Concentration-time Curve From Time 0 to Infinity for TAK-500
Dose Escalation and Dose Expansion: AUCt: Area Under the Serum Concentration-time Curve From Time 0 to Time t for TAK-500
Dose Escalation and Dose Expansion: CL: Total Clearance After Intravenous Administration for TAK-500
+17 moreSide effects data
From 2022 Phase 2 trial • 40 Patients • NCT0301808071%
Fatigue
43%
Peripheral sensory neuropathy
38%
Headache
38%
Alopecia
33%
Nausea
29%
Hypothyroidism
29%
Pain
29%
Cough
29%
Dyspnea
24%
Constipation
24%
Rash maculo-papular
19%
Diarrhea
19%
Pain in extremity
19%
Abdominal pain
19%
Bloating
19%
Anorexia
19%
Dyspepsia
19%
Infusion related reaction
14%
Edema limbs
14%
Nasal congestion
14%
Anemia
14%
Sinusitis
14%
Dehydration
14%
Hyperglycemia
14%
Hypokalemia
14%
Allergic rhinitis
10%
Mucositis oral
10%
Myalgia
10%
Dizziness
10%
Flushing
10%
Aspartate aminotransferase increased
10%
Hyperthyroidism
10%
Vomiting
10%
Chills
10%
Fall
10%
Hoarseness
10%
Restlessness
10%
Alanine aminotransferase increased
10%
Neutrophil count decreased
10%
Dry mouth
10%
Localized edema
10%
Skin infection
10%
Back pain
10%
Pneumonitis
10%
Pruritus
10%
Hot flashes
10%
Lymphedema
10%
Thromboembolic event
5%
Recurrent laryngeal nerve palsy
5%
Flashing lights
5%
Skin hyperpigmentation
5%
Conjunctivitis
5%
Eye disorders - Other
5%
Dysgeusia
5%
Eye disorders - Other, specify
5%
Blood bilirubin increased
5%
Creatinine increased
5%
Platelet count decreased
5%
Hypomagnesemia
5%
Hyponatremia
5%
Atrial flutter
5%
Metabolism and nutrition disorders - Other, specify
5%
Hypoglycemia
5%
Allergic reaction
5%
Syncope
5%
Lung infection
5%
Lymph gland infection
5%
Bruising
5%
Hypoxia
5%
Hepatobiliary disorders - Other, specify
5%
Infections and infestations - Other, specify
5%
Fever
5%
Hepatobiliary disorders - Other
5%
Sneezing
5%
Insomnia
5%
Urinary frequency
5%
Epistaxis
5%
Laryngeal hemorrhage
5%
Sore throat
5%
Hepatic failure
5%
Respiratory failure
5%
Alkaline phosphatase increased
5%
Gastrointestinal disorders - Other
5%
Malaise
5%
Non-cardiac chest pain
5%
Infections and infestations - Other
5%
Mucosal infection
5%
Nail infection
5%
Upper respiratory infection
5%
Urinary tract infection
5%
Hypocalcemia
5%
Hypophosphatemia
5%
Metabolism and nutrition disorders - Other
5%
Bone pain
5%
Urinary incontinence
5%
Urinary tract pain
5%
Urinary urgency
5%
Postnasal drip
5%
Nail loss
5%
Nail ridging
5%
Periorbital edema
5%
Hypertension
5%
Hypotension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm A (Phased Pembrolizumab Regimen)
Arm B (Concurrent Pembrolizumab Regimen)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
9Treatment groups
Experimental Treatment
Group I: Dose Expansion: 3L RCC: TAK-500 + Pembrolizumab (RDE 1)Experimental Treatment2 Interventions
Participants with 3L renal clear cell carcinoma (RCC) will receive TAK-500, infusion, intravenously, in a 42-day treatment cycle (Q2W or Q3W) with pembrolizumab 200 mg infusion, intravenously, in a 42-day treatment cycle (Q3W) for up to 1 year. The recommended dose (RDE 1) and schedule of TAK-500 for expansion will be based on the results of the TAK-500 in combination with pembrolizumab Dose Escalation arm.
Group II: Dose Expansion: 3L NSCLC: TAK-500 (RDE 2) SAExperimental Treatment1 Intervention
Participants with 3L NSCLC will receive TAK-500, infusion, intravenously, in a 42-day treatment cycle (Q2W or Q3W) for up to 1 year. The recommended dose (RDE 2) and schedule of TAK-500 for expansion will be based on the results of the TAK-500 as single agent in Dose Escalation arm.
Group III: Dose Expansion: 3L NSCLC: TAK-500 (RDE 1) SAExperimental Treatment1 Intervention
Participants with third-line (3L) NSCLC will receive TAK-500, infusion, intravenously, in a 42-day treatment cycle (Q2W or Q3W) for up to 1 year. The recommended dose (RDE 1) and schedule of TAK-500 for expansion will be based on the results of the TAK-500 as single agent in Dose Escalation arm.
Group IV: Dose Expansion: 2L Pancreatic Adenocarcinoma: TAK-500 + Pembrolizumab (RDE 1)Experimental Treatment2 Interventions
Participants with 2L Pancreatic Adenocarcinoma will receive TAK-500, infusion, intravenously, in a 42-day treatment cycle (Q2W or Q3W) with pembrolizumab 200 mg infusion, intravenously, in a 42-day treatment cycle (Q3W) for up to 1 year. The recommended dose (RDE 1) and schedule of TAK-500 for expansion will be based on the results of the TAK-500 in combination with pembrolizumab Dose Escalation arm.
Group V: Dose Expansion: 2L Pancreatic Adeno: TAK-500 (RDE 1) SAExperimental Treatment1 Intervention
Participants with 2L Pancreatic Adenocarcinoma will receive TAK-500, infusion, intravenously, in a 42-day treatment cycle (Q2W or Q3W) for up to 1 year. The recommended dose (RDE 1) and schedule of TAK-500 for expansion will be based on the results of the TAK-500 as single agent in Dose Escalation arm.
Group VI: Dose Expansion: 2L NSCLC: TAK-500 + Pembrolizumab (RDE 2)Experimental Treatment2 Interventions
Participants with 2L NSCLC will receive TAK-500, infusion, intravenously, in a 42-day treatment cycle (Q2W or Q3W) with pembrolizumab 200 mg infusion, intravenously, in a 42-day treatment cycle (Q3W) for up to 1 year. The recommended dose (RDE 2) and schedule of TAK-500 for expansion will be based on the results of the TAK-500 in combination with pembrolizumab Dose Escalation arm.
Group VII: Dose Expansion: 2L NSCLC: TAK-500 + Pembrolizumab (RDE 1)Experimental Treatment2 Interventions
Participants with second-line (2L) non-small cell lung cancer (NSCLC) will receive TAK-500, infusion, intravenously, in a 42-day treatment cycle (Q2W or Q3W) with pembrolizumab 200 mg infusion, intravenously, in a 42-day treatment cycle (Q3W) for up to 1 year. The recommended dose (RDE 1) and schedule of TAK-500 for expansion will be based on the results of the TAK-500 in combination with pembrolizumab Dose Escalation arm.
Group VIII: Dose Escalation: TAK-500 Single Agent (SA)Experimental Treatment1 Intervention
TAK-500 dose escalation starting at 8 microgram per kilogram (mcg/kg), infusion, intravenously, once on Day 1 of each 21-day treatment cycle (once every 3 weeks, Q3W) or once on Day 1, 15 and 29 of each 42-day treatment cycle (once every 2 weeks, Q2W), for up to 1 year.
Group IX: Dose Escalation: TAK-500 + PembrolizumabExperimental Treatment2 Interventions
TAK-500, infusion, intravenously, once on Day 1 of each 21-day treatment cycle (once every 3 weeks, Q3W) or once on Day 1, 15 and 29 of each 42-day treatment cycle (once every 2 weeks, Q2W), for up to 1 year, along with pembrolizumab 200 milligram (mg) infusion, intravenously, once on Day 1 of each 21-day treatment cycle or on Days 1 and 22 in a 42-day cycle (Q3W) for up to 1 year. The exact starting dose of TAK-500 will be determined from the results of the TAK-500 SA arm dose escalation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 3
~2030
Find a Location
Who is running the clinical trial?
TakedaLead Sponsor
1,180 Previous Clinical Trials
4,176,428 Total Patients Enrolled
Study DirectorStudy DirectorTakeda
1,172 Previous Clinical Trials
485,284 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been using e-cigarettes or vaping within the past 90 days before starting the study drug.You are currently a smoker.You have taken certain medications that affect the immune system in the past 6 months.You have been diagnosed with serious lung conditions such as pneumonitis, interstitial lung disease, chronic obstructive pulmonary disease (COPD), or pulmonary fibrosis. You also have severe pleural effusion (fluid around the lungs) that is not controlled by tapping or requires a catheter.You are using corticosteroids that are applied to the skin, nose, eyes, joints, or inhaled, but not taken by mouth or injected into your veins.You are taking a low dose of steroid medication to replace what your body doesn't make enough of. The dose should not be more than 10 mg of prednisone per day.You have been diagnosed with advanced or spread-out tumors in certain areas of your body, such as the stomach, pancreas, liver, lung, head and neck, breast, kidney, or nasopharynx. You have already tried all standard treatments for your type of cancer, and either the treatments did not work or you had side effects that made it impossible to continue with them.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Expansion: 2L NSCLC: TAK-500 + Pembrolizumab (RDE 2)
- Group 2: Dose Expansion: 3L NSCLC: TAK-500 (RDE 2) SA
- Group 3: Dose Expansion: 2L Pancreatic Adenocarcinoma: TAK-500 + Pembrolizumab (RDE 1)
- Group 4: Dose Expansion: 3L NSCLC: TAK-500 (RDE 1) SA
- Group 5: Dose Expansion: 2L NSCLC: TAK-500 + Pembrolizumab (RDE 1)
- Group 6: Dose Escalation: TAK-500 Single Agent (SA)
- Group 7: Dose Expansion: 3L RCC: TAK-500 + Pembrolizumab (RDE 1)
- Group 8: Dose Escalation: TAK-500 + Pembrolizumab
- Group 9: Dose Expansion: 2L Pancreatic Adeno: TAK-500 (RDE 1) SA
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How secure is the application of TAK-500 for human health?
"Due to the limited safety and efficacy data surrounding TAK-500, it received a score of 1."
Answered by AI
In what geographic locations is this trial carrying out its research?
"Besides the University of Colorado - Anschutz Medical Campus - PPDS in Aurora, Dana Farber Cancer Institute in Boston, and Cancer Clinical Trials Office (CCTO) University of Colorado Anschutz Medical Campus in Denver, this trial is also recruiting patients from 8 other medical centres."
Answered by AI
Is there still the opportunity to join this clinical exploration?
"According to clinicaltrials.gov, this medical trial is actively seeking participants after first being posted on April 26th 2022 and most recently updated on August 3rd of the same year."
Answered by AI
For what medical conditions is TAK-500 commonly employed?
"TAK-500 is frequently utilized to treat malignancies. It can also be beneficial in the management of unresectable melanoma, microsatellite instability high, and as a response to chemotherapy failure."
Answered by AI
How extensive is the scope of participants in this particular research study?
"In order to proceed with the clinical trial, a total of 106 qualified participants are required. The sponsor for this study, Takeda Pharmaceuticals, is recruiting patients from two sites - University of Colorado - Anschutz Medical Campus- PPDS in Aurora and Dana Farber Cancer Institute in Boston."
Answered by AI
What other exploratory trials have been conducted with TAK-500?
"At the moment, there are 961 clinical trials for TAK-500. Of those active studies, 122 have progressed to Phase 3. Many of these experiments take place in Houston, Texas; however, it should be noted that 35731 sites around the world offer this medication as part of a research study."
Answered by AI
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