Metastatic Urothelial CancerPhase 1NCT03070990
A Study of Enfortumab Vedotin in Japanese Subjects With Locally Advanced or Metastatic Urothelial Carcinoma
A Phase 1 study testing Enfortumab vedotin in people with Metastatic Urothelial Cancer, run by Astellas Pharma Inc at 8 sites in Japan.
Trial summary
The objective of this study is to assess the safety, tolerability and pharmacokinetics of enfortumab vedotin (ASG-22CE) when administered intravenously to Japanese subjects with locally advanced or metastatic urothelial carcinoma. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Metastatic Urothelial Cancer
- What is being tested?
- Enfortumab vedotin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 8 sitesJapan
- Study dates
- 24 Apr 2017to 25 Feb 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject must have histologically confirmed, locally advanced (TNM classification T3b and any N; or T and N2-3) or metastatic Transitional Cell Carcinoma of the Urothelium (TCCU) (i.e., cancer of the bladder, renal pelvis, ureter, or urethra). Subjects with Urothelial Carcinoma with squamous differentiation or mixed cell types are eligible.
- Subject must be able to submit a tumor tissue samples for Nectin-4 expression analysis at central laboratory.
- Subject must have failed at least one prior chemotherapy regimen for advanced disease. Urothelial and bladder cancer subjects are not required to have failed prior chemotherapy regimen if considered unfit for cisplatin-based chemotherapy.
- Subject must have measurable disease according to Response Evaluation Criteria in Solid Tumor (RECIST) (version 1.1).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Who cannot join
- Preexisting sensory neuropathy Grade ≥ 2.
- Preexisting motor neuropathy Grade ≥ 2.
- Uncontrolled central nervous system metastasis that requires active treatment.
- Any anticancer therapy within 14 days prior to the first dose of study drug.
- Subjects with pre-existing immunotherapy-related adverse events requiring high doses of systemic steroids are not eligible.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Japan8 sites
Site JP00004
Chuo-ku, Tokyo
Site JP00006
Fukuoka
Site JP00007
Koto-ku, Tokyo
Site JP00001
Niigata
Site JP00002
Okayama
Site JP00005
Sendai, Miyagi
Site JP00008
Suita, Osaka
Site JP00003
Tsukuba, Ibaraki
About this study
Official title: An Open-label, Randomized, Phase 1 Safety and Pharmacokinetic Study of Enfortumab Vedotin (ASG-22CE) in Japanese Patients With Locally Advanced or Metastatic Urothelial Carcinoma
The objective of this study is to assess the safety, tolerability and pharmacokinetics of enfortumab vedotin (ASG-22CE) when administered intravenously to Japanese subjects with locally advanced or metastatic urothelial carcinoma. This study will also assess the immunogenicity as defined by the incidence of anti-drug antibody (ADA) and anti-tumor activity of enfortumab vedotin (ASG-22CE) when administered intravenously to Japanese subjects with locally advanced or metastatic urothelial carcinoma.
Read the detailed description
All subjects will receive a single 30 minute intravenous (IV) infusion of enfortumab vedotin (ASG-22CE) once weekly for 3 weeks of every 4 weeks (i.e., on Days 1, 8, and 15). A cycle is 28 days.
- Conditions
- Metastatic Urothelial Cancer
- Being tested
- Enfortumab vedotin
- Keywords
- Urothelial Carcinoma, Enfortumab vedotin, ASG-22CE, Padcev, ASG-22ME, Metastatic Urothelial Cancer
- Medical subject headings
- Carcinoma, Transitional Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enfortumab vedotinDrug
Also called ASG-22CE, Padcev
All subjects assigned will receive a single 30 minute intravenous infusion of enfortumab vedotin (ASG-22CE) once weekly for 3 weeks of every 4 weeks (i.e., on Days 1, 8, and 15). A cycle is 28 days.
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Enfortumab vedotin 1.0 mg/kg | Experimental | All subjects assigned will receive a single 30 minute intravenous infusion of enfortumab vedotin (ASG-22CE) once weekly for 3 weeks of every 4 weeks (i.e., on Days 1, 8, and 15). A cycle is 28 days. Receives: Drug: Enfortumab vedotin |
| Arm B: Enfortumab vedotin 1.25 mg/kg | Experimental | All subjects assigned will receive a single 30 minute intravenous infusion of enfortumab vedotin (ASG-22CE) once weekly for 3 weeks of every 4 weeks (i.e., on Days 1, 8, and 15). A cycle is 28 days. Receives: Drug: Enfortumab vedotin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety assessed by incidence of adverse events
Adverse events will be coded using MedDRA. Adverse events collection begins after signing informed consent and collected until 28 days after the last dose of study drug.
Measured: Up to 12 months
Safety assessed by laboratory tests: Hematology
Descriptive statistics will be used to summarize results.
Measured: Up to 12 months
Safety assessed by laboratory tests: Biochemistry
Descriptive statistics will be used to summarize results.
Measured: Up to 12 months
Safety assessed by laboratory tests: Urinalysis
Descriptive statistics will be used to summarize results.
Measured: Up to 12 months
Safety assessed by laboratory tests: Coagulation studies
Descriptive statistics will be used to summarize results.
Measured: Up to 12 months
Number of participants with vital sign abnormalities and/or adverse events
Number of participants with potentially clinically significant vital sign values.
Measured: Up to 12 months
Safety assessed by electrocardiogram (ECG)
Before measurement of ECGs, the participant should be resting in a supine position for at least 5 minutes. The investigator will assess the ECG charts as "normal", "abnormal (not clinically significant)" or "abnormal (clinically significant)". "Abnormal (not clinically significant)" and "abnormal (clinically significant)" findings will be recorded.
Measured: Up to 12 months
Pharmacokinetics (PK) parameter for total antibody (TAb): Concentration at the end of infusion (CEOI)
CEOI will be derived from the PK blood samples collected.
Measured: Days 1-4, 8, 15-18, 22 of Cycle 1, Day 1 of Cycle 2 and 3, and subsequent cycles up to an average of 12 months
Pharmacokinetics (PK) parameter for antibody drug conjugate (ADC): CEOI
CEOI will be derived from the PK blood samples collected.
Measured: Days 1-4, 8, 15-18, 22 of Cycle 1, Day 1 of Cycle 2 and 3, and subsequent cycles up to an average of 12 months
Pharmacokinetics (PK) parameter for Monomethyl Auristatin E (MMAE): CEOI
CEOI will be derived from the PK blood samples collected.
Measured: Days 1-4, 8, 15-18, 22 of Cycle 1, Day 1 of Cycle 2 and 3, and subsequent cycles up to an average of 12 months
PK parameter for TAb: Maximum observed concentration (Cmax)
Cmax will be derived from the PK blood samples collected.
Measured: Days 1-4, 8, 15-18, 22 of Cycle 1, Day 1 of Cycle 2 and 3, and subsequent cycles up to an average of 12 months
PK parameter for ADC: Cmax
Cmax will be derived from the PK blood samples collected.
Measured: Days 1-4, 8, 15-18, 22 of Cycle 1, Day 1 of Cycle 2 and 3, and subsequent cycles up to an average of 12 months
PK parameter for MMAE: Cmax
Cmax will be derived from the PK blood samples collected.
Measured: Days 1-4, 8, 15-18, 22 of Cycle 1, Day 1 of Cycle 2 and 3, and subsequent cycles up to an average of 12 months
PK parameter for TAb: Trough concentration (Ctrough)
Ctrough will be derived from the PK blood samples collected.
Measured: Days 1-4, 8, 15-18, 22 of Cycle 1, Day 1 of Cycle 2 and 3, and subsequent cycles up to an average of 12 months
PK parameter for ADC: Ctrough
Ctrough will be derived from the PK blood samples collected.
Measured: Days 1-4, 8, 15-18, 22 of Cycle 1, Day 1 of Cycle 2 and 3, and subsequent cycles up to an average of 12 months
PK parameter for MMAE: Ctrough
Ctrough will be derived from the PK blood samples collected.
Measured: Days 1-4, 8, 15-18, 22 of Cycle 1, Day 1 of Cycle 2 and 3, and subsequent cycles up to an average of 12 months
PK parameter for TAb: Time to maximum concentration (Tmax)
Tmax will be derived from the PK blood samples collected.
Measured: Days 1-4, 8, 15-18, 22 of Cycle 1, Day 1 of Cycle 2 and 3, and subsequent cycles up to an average of 12 months
PK parameter for ADC: Tmax
Tmax will be derived from the PK blood samples collected.
Measured: Days 1-4, 8, 15-18, 22 of Cycle 1, Day 1 of Cycle 2 and 3, and subsequent cycles up to an average of 12 months
PK parameter for MMAE: Tmax
Tmax will be derived from the PK blood samples collected.
Measured: Days 1-4, 8, 15-18, 22 of Cycle 1, Day 1 of Cycle 2 and 3, and subsequent cycles up to an average of 12 months
PK parameter for TAb: Partial area under the serum concentration-time curve after first dose and as appropriate (AUC0-7)
AUC0-7 will be derived from the PK blood samples collected.
Measured: Days 1-4, 8, 15-18, 22 of Cycle 1, Day 1 of Cycle 2 and 3, and subsequent cycles up to an average of 12 months
PK parameter for ADC: AUC0-7
AUC0-7 will be derived from the PK blood samples collected.
Measured: Days 1-4, 8, 15-18, 22 of Cycle 1, Day 1 of Cycle 2 and 3, and subsequent cycles up to an average of 12 months
PK parameter for MMAE: AUC0-7
AUC0-7 will be derived from the PK blood samples collected.
Measured: Days 1-4, 8, 15-18, 22 of Cycle 1, Day 1 of Cycle 2 and 3, and subsequent cycles up to an average of 12 months
PK parameter for TAb: Terminal or apparent terminal half-life (t1/2)
T1/2 will be derived from the PK blood samples collected.
Measured: Days 1-4, 8, 15-18, 22 of Cycle 1, Day 1 of Cycle 2 and 3, and subsequent cycles up to an average of 12 months
PK parameter for ADC: t1/2
T1/2 will be derived from the PK blood samples collected.
Measured: Days 1-4, 8, 15-18, 22 of Cycle 1, Day 1 of Cycle 2 and 3, and subsequent cycles up to an average of 12 months
PK parameter for MMAE: t1/2
T1/2 will be derived from the PK blood samples collected.
Measured: Days 1-4, 8, 15-18, 22 of Cycle 1, Day 1 of Cycle 2 and 3, and subsequent cycles up to an average of 12 months
Secondary outcomes (3)
Incidence of Anti-Drug Antibody (ADA)
Blood samples for anti-drug antibody (ADA) analysis will be collected.
Measured: Up to 12 months
Overall Response Rate
Defined as the proportion of subjects whose best overall response is rated as complete response (CR) or partial response (PR)
Measured: Up to 12 months
Disease Control Rate
Defined as the proportion of subjects whose best overall response is rated as CR, PR, or stable disease (SD)
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2017
- Study start24 Apr 2017
- Primary completion25 Feb 2019
- Study completion25 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Urothelial CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Seagen Inc.
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03070990
- Sponsor's protocol ID
- 7465-CL-0101
- Status last verified
- Oct 2024
- First submitted
- 1 Mar 2017
- Last updated
- 18 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Publications
Takahashi S, Uemura M, Kimura T, Kawasaki Y, Takamoto A, Yamaguchi A, Melhem-Bertrandt A, Gartner EM, Inoue T, Akazawa R, Kadokura T, Tanikawa T. A phase I study of enfortumab vedotin in Japanese patients with locally advanced or metastatic urothelial carcinoma. Invest New Drugs. 2020 Aug;38(4):1056-1066. doi: 10.1007/s10637-019-00844-x. Epub 2019 Aug 14.
PubMed 31444589
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Phase 1 Safety and Pharmacokinetic Study of Enfortumab Vedotin (ASG-22CE) in Japanese Patients With Locally Advanced or Metastatic Urothelial Carcinoma
- ClinicalTrials.gov ID
- NCT03070990
- Acronym / sponsor ID
- 7465-CL-0101
- Conditions
- Metastatic Urothelial Cancer
- Keywords
- Urothelial Carcinoma, Enfortumab vedotin, ASG-22CE, Padcev, ASG-22ME, Metastatic Urothelial Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Collaborators
- Seagen Inc.
- Study start
- 24 Apr 2017 (actual)
- Primary completion
- 25 Feb 2019 (actual)
- Study completion
- 25 Feb 2019 (actual)
- First posted
- 6 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to assess the safety, tolerability and pharmacokinetics of enfortumab vedotin (ASG-22CE) when administered intravenously to Japanese subjects with locally advanced or metastatic urothelial carcinoma. This study will also assess the immunogenicity as defined by the incidence of anti-drug antibody (ADA) and anti-tumor activity of enfortumab vedotin (ASG-22CE) when administered intravenously to Japanese subjects with locally advanced or metastatic urothelial carcinoma.
Detailed description
All subjects will receive a single 30 minute intravenous (IV) infusion of enfortumab vedotin (ASG-22CE) once weekly for 3 weeks of every 4 weeks (i.e., on Days 1, 8, and 15). A cycle is 28 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Enfortumab vedotin 1.0 mg/kg | Experimental | Drug: Enfortumab vedotinAll subjects assigned will receive a single 30 minute intravenous infusion of enfortumab vedotin (ASG-22CE) once weekly for 3 weeks of every 4 weeks (i.e., on Days 1, 8, and 15). A cycle is 28 days. |
| Arm B: Enfortumab vedotin 1.25 mg/kg | Experimental | Drug: Enfortumab vedotinAll subjects assigned will receive a single 30 minute intravenous infusion of enfortumab vedotin (ASG-22CE) once weekly for 3 weeks of every 4 weeks (i.e., on Days 1, 8, and 15). A cycle is 28 days. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject must have histologically confirmed, locally advanced (TNM classification T3b and any N; or T and N2-3) or metastatic Transitional Cell Carcinoma of the Urothelium (TCCU) (i.e., cancer of the bladder, renal pelvis, ureter, or urethra). Subjects with Urothelial Carcinoma with squamous differentiation or mixed cell types are eligible.
- Subject must be able to submit a tumor tissue samples for Nectin-4 expression analysis at central laboratory.
- Subject must have failed at least one prior chemotherapy regimen for advanced disease. Urothelial and bladder cancer subjects are not required to have failed prior chemotherapy regimen if considered unfit for cisplatin-based chemotherapy.
- Subject must have measurable disease according to Response Evaluation Criteria in Solid Tumor (RECIST) (version 1.1).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Key exclusion criteria (5 listed)
- Preexisting sensory neuropathy Grade ≥ 2.
- Preexisting motor neuropathy Grade ≥ 2.
- Uncontrolled central nervous system metastasis that requires active treatment.
- Any anticancer therapy within 14 days prior to the first dose of study drug.
- Subjects with pre-existing immunotherapy-related adverse events requiring high doses of systemic steroids are not eligible.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enfortumab vedotinAlso: ASG-22CE, PadcevAll subjects assigned will receive a single 30 minute intravenous infusion of enfortumab vedotin (ASG-22CE) once weekly for 3 weeks of every 4 weeks (i.e., on Days 1, 8, and 15). A cycle is 28 days. | Drug | Arm A: Enfortumab vedotin 1.0 mg/kg, Arm B: Enfortumab vedotin 1.25 mg/kg |
Primary outcome
Safety assessed by incidence of adverse events
Time frame: Up to 12 months
Adverse events will be coded using MedDRA. Adverse events collection begins after signing informed consent and collected until 28 days after the last dose of study drug.
Safety assessed by laboratory tests: Hematology
Time frame: Up to 12 months
Descriptive statistics will be used to summarize results.
Safety assessed by laboratory tests: Biochemistry
Time frame: Up to 12 months
Descriptive statistics will be used to summarize results.
Safety assessed by laboratory tests: Urinalysis
Time frame: Up to 12 months
Descriptive statistics will be used to summarize results.
Safety assessed by laboratory tests: Coagulation studies
Time frame: Up to 12 months
Descriptive statistics will be used to summarize results.
Number of participants with vital sign abnormalities and/or adverse events
Time frame: Up to 12 months
Number of participants with potentially clinically significant vital sign values.
Safety assessed by electrocardiogram (ECG)
Time frame: Up to 12 months
Before measurement of ECGs, the participant should be resting in a supine position for at least 5 minutes. The investigator will assess the ECG charts as "normal", "abnormal (not clinically significant)" or "abnormal (clinically significant)". "Abnormal (not clinically significant)" and "abnormal (clinically significant)" findings will be recorded.
Pharmacokinetics (PK) parameter for total antibody (TAb): Concentration at the end of infusion (CEOI)
Time frame: Days 1-4, 8, 15-18, 22 of Cycle 1, Day 1 of Cycle 2 and 3, and subsequent cycles up to an average of 12 months
CEOI will be derived from the PK blood samples collected.
Pharmacokinetics (PK) parameter for antibody drug conjugate (ADC): CEOI
Time frame: Days 1-4, 8, 15-18, 22 of Cycle 1, Day 1 of Cycle 2 and 3, and subsequent cycles up to an average of 12 months
CEOI will be derived from the PK blood samples collected.
Pharmacokinetics (PK) parameter for Monomethyl Auristatin E (MMAE): CEOI
Time frame: Days 1-4, 8, 15-18, 22 of Cycle 1, Day 1 of Cycle 2 and 3, and subsequent cycles up to an average of 12 months
CEOI will be derived from the PK blood samples collected.
PK parameter for TAb: Maximum observed concentration (Cmax)
Time frame: Days 1-4, 8, 15-18, 22 of Cycle 1, Day 1 of Cycle 2 and 3, and subsequent cycles up to an average of 12 months
Cmax will be derived from the PK blood samples collected.
PK parameter for ADC: Cmax
Time frame: Days 1-4, 8, 15-18, 22 of Cycle 1, Day 1 of Cycle 2 and 3, and subsequent cycles up to an average of 12 months
Cmax will be derived from the PK blood samples collected.
PK parameter for MMAE: Cmax
Time frame: Days 1-4, 8, 15-18, 22 of Cycle 1, Day 1 of Cycle 2 and 3, and subsequent cycles up to an average of 12 months
Cmax will be derived from the PK blood samples collected.
PK parameter for TAb: Trough concentration (Ctrough)
Time frame: Days 1-4, 8, 15-18, 22 of Cycle 1, Day 1 of Cycle 2 and 3, and subsequent cycles up to an average of 12 months
Ctrough will be derived from the PK blood samples collected.
PK parameter for ADC: Ctrough
Time frame: Days 1-4, 8, 15-18, 22 of Cycle 1, Day 1 of Cycle 2 and 3, and subsequent cycles up to an average of 12 months
Ctrough will be derived from the PK blood samples collected.
PK parameter for MMAE: Ctrough
Time frame: Days 1-4, 8, 15-18, 22 of Cycle 1, Day 1 of Cycle 2 and 3, and subsequent cycles up to an average of 12 months
Ctrough will be derived from the PK blood samples collected.
PK parameter for TAb: Time to maximum concentration (Tmax)
Time frame: Days 1-4, 8, 15-18, 22 of Cycle 1, Day 1 of Cycle 2 and 3, and subsequent cycles up to an average of 12 months
Tmax will be derived from the PK blood samples collected.
PK parameter for ADC: Tmax
Time frame: Days 1-4, 8, 15-18, 22 of Cycle 1, Day 1 of Cycle 2 and 3, and subsequent cycles up to an average of 12 months
Tmax will be derived from the PK blood samples collected.
PK parameter for MMAE: Tmax
Time frame: Days 1-4, 8, 15-18, 22 of Cycle 1, Day 1 of Cycle 2 and 3, and subsequent cycles up to an average of 12 months
Tmax will be derived from the PK blood samples collected.
PK parameter for TAb: Partial area under the serum concentration-time curve after first dose and as appropriate (AUC0-7)
Time frame: Days 1-4, 8, 15-18, 22 of Cycle 1, Day 1 of Cycle 2 and 3, and subsequent cycles up to an average of 12 months
AUC0-7 will be derived from the PK blood samples collected.
PK parameter for ADC: AUC0-7
Time frame: Days 1-4, 8, 15-18, 22 of Cycle 1, Day 1 of Cycle 2 and 3, and subsequent cycles up to an average of 12 months
AUC0-7 will be derived from the PK blood samples collected.
PK parameter for MMAE: AUC0-7
Time frame: Days 1-4, 8, 15-18, 22 of Cycle 1, Day 1 of Cycle 2 and 3, and subsequent cycles up to an average of 12 months
AUC0-7 will be derived from the PK blood samples collected.
PK parameter for TAb: Terminal or apparent terminal half-life (t1/2)
Time frame: Days 1-4, 8, 15-18, 22 of Cycle 1, Day 1 of Cycle 2 and 3, and subsequent cycles up to an average of 12 months
T1/2 will be derived from the PK blood samples collected.
PK parameter for ADC: t1/2
Time frame: Days 1-4, 8, 15-18, 22 of Cycle 1, Day 1 of Cycle 2 and 3, and subsequent cycles up to an average of 12 months
T1/2 will be derived from the PK blood samples collected.
PK parameter for MMAE: t1/2
Time frame: Days 1-4, 8, 15-18, 22 of Cycle 1, Day 1 of Cycle 2 and 3, and subsequent cycles up to an average of 12 months
T1/2 will be derived from the PK blood samples collected.
3 secondary outcomes
Incidence of Anti-Drug Antibody (ADA)
Time frame: Up to 12 months
Overall Response Rate
Time frame: Up to 12 months
Disease Control Rate
Time frame: Up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2024.
- Derived from this study: PubMed 31444589Takahashi S, Uemura M, Kimura T, Kawasaki Y, Takamoto A, Yamaguchi A, Melhem-Bertrandt A, Gartner EM, Inoue T, Akazawa R, Kadokura T, Tanikawa T. A phase I study of enfortumab vedotin in Japanese patients with locally advanced or metastatic urothelial carcinoma. Invest New Drugs. 2020 Aug;38(4):1056-1066. doi: 10.1007/s10637-019-00844-x. Epub 2019 Aug 14.
- Individual participant dataSharing planned: No. Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Astellas Pharma Inc
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Enfortumab vedotin in people with Metastatic Urothelial Cancer, run by Astellas Pharma Inc at 8 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety assessed by incidence of adverse events (time frame: Up to 12 months). The study lists 25 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03070990, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2024.