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Non-muscle Invasive Bladder CancerPhase 3ACCRUENCT04490993

Safety and Efficacy of APL-1202 in Combination With Epirubicin Hydrochloride Versus Epirubicin Hydrochloride Alone in Intermediate and High-risk Chemo-refractory Non-muscle Invasive Bladder Cancer (NMIBC) Patients

A Phase 3 study testing APL-1202 in combination with Epirubicin in people with Non-muscle Invasive Bladder Cancer, run by Jiangsu Yahong Meditech Co., Ltd aka Asieris at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To evaluate the clinical efficacy (median event-free survival) of APL-1202 in combination with Epirubicin hydrochloride versus Epirubicin hydrochloride alone in intermediate and high-risk chemo-refractory non-muscle invasive bladder cancer (NMIBC) patients Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-muscle Invasive Bladder Cancer
What is being tested?
APL-1202 in combination with Epirubicin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
359 participants
Where
1 siteChina
Study dates
30 Mar 2017to 30 May 2022
Phase
Phase 3
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Must be informed of the investigational nature of this study and must provide written informed consent
  • Age ≥18 years, male or female
  • Must have clinically and histologically confirmed recurrent intermediate and high-risk non-muscle invasive transitional cell carcinoma of the bladder after treatment with intravesical chemotherapy. EORTC risk score (according to EUA "NMIBC Guideline" 2015 version) must be ≥ 5: Papilloma alone (or with Cis) or Cis alone No visible tumor after TURBT on tumor lesion
  • Medical history of intravesical chemotherapy Subjects who received intravesical chemotherapy prior to enrollment, but didn't receive BCG or other intravesical therapy with immune drugs Subjected who are refractory to the recommended intravesical chemotherapy drugs pirarubicin, epirubicin, doxorubicin, hydroxy camptothecin, mitomycin, or gemcitabine (according to "Guideline of Diagnosis and Treatment of Urological Diseases in China", 2014 version)
  • Re-TURBT:
  • For subjects undergoing secondary TURBT, EORTC risk score must be ≥ 5, which can be assessed based on the results of any TURBTs. The other results will be based on first TURBT For subjects undergoing secondary TURBT, the enrollment time will start from the second TURBT It is recommended to conduct the secondary TURBT under following situations: incomplete first TURBT; no muscle tissue found in the first TURBT specimen, except Ta G1 (low grade) tumor and CIS only; T1 tumor; G3 (high grade) tumor (except CIS) The secondary TURBT is recommended 2-6 weeks, but better at 4 weeks, after the first TURBT
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  • Willing to provide biopsy specimen for assessment
  • ECOG PS ≤ 1, and did not deteriorate in 7 days
  • Patients must have normal organ and marrow function within 42 days of study entry (according to normal range in clinical site) Absolute neutrophil count >1.0×109/L Platelets > 100 ×109/L Hemoglobin > 9.0 g/dl Alkaline phosphatase < 2.5 ULN (<10 X ULN in presence of bone metastasis) GFR (Cockcroft-Gault formula calculated) ≥ 50 ml/min INR <1.5, except for subjects receiving warfarin therapy
  • Eligibility of patients receiving any medications or substances known to affect or with the potential to affect the activity or pharmacokinetics of APL-1202 will be determined following review of their case by the Principal Investigator
  • Female should be either surgically sterilized or menopause or agree to use effective contraceptive measures during treatment
  • Male subjects must be surgically sterilized or agreed to use effective contraceptive measures. Subjects must continue to take contraceptive measures within 3 months of the end of the study treatment. The definition of effective contraceptive measures will be based on the Principal Investigator or appointed delegate;
  • Expected life expectancy is more than 30 months

Who cannot join

  • TBIL, ALT or AST >1.5 x normal range (according to normal range in clinical sites)
  • Urothelial cell carcinoma in upper urethra or ureter
  • Received intravesical therapy in last TURBT/cystoscopy prior to enrollment period, but not including immediate intravesical therapy once (the subjects who received the immediate intravesical therapy need to be recorded in e-CRF)
  • Received surgery (not includes TURBT/cystoscopy), radiation therapy, or systemic therapy within 6 weeks before enrollment
  • Malignancies within 2 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in-situ' of the cervix
  • NCI CTCAE grade 3 hemorrhage within 6 weeks of starting study treatment
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  • Any of the following within 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism
  • Hypertension that cannot be controlled by medications
  • systolic blood pressure≥140 mmHg and/or diastolic blood pressure≥90mmHg
  • Uncontrolled active infections such as acute pneumonia, active hepatitis B, etc.
  • Dysphagia or known drug absorption disorders
  • Anuria
  • One week prior to enrollment, having hematuria
  • Active duodenal ulcers, ulcerative colitis and other gastrointestinal diseases or other conditions that the investigator may determine to cause gastrointestinal bleeding or perforation
  • Subjects that may increase the risk associated with study participation or study drug administration, judged by investigator, or other severe acute or chronic medical condition or optic nerve disorders may interfere with the interpretation and judgment of study results
  • Pregnancy or breastfeeding. Female patients with reproductive potential have a positive pregnancy test prior to enrollment
  • Psychological or mental abnormality, subjects are estimated to have insufficient adherence to this clinical study
  • Four weeks prior to enrollment, participate in other clinical trials
  • Patients who had previously received anthracycline for systemic chemotherapy

Trial locations and contacts

1 site in 1 country.

China1 site

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality

Other trials in China

About this study

Official title: A Multi-center, Randomized, Double-blind, Placebo-controlled Phase Ⅲ Clinical Trial to Evaluate the Clinical Safety and Efficacy of APL-1202 in Combination With Epirubicin Hydrochloride Versus Epirubicin Hydrochloride Alone in Intermediate and High-risk Chemo-refractory Non-muscle Invasive Bladder Cancer (NMIBC) Patients

To evaluate the clinical efficacy (median event-free survival) of APL-1202 in combination with Epirubicin hydrochloride versus Epirubicin hydrochloride alone in intermediate and high-risk chemo-refractory non-muscle invasive bladder cancer (NMIBC) patients

Read the detailed description

A multi-center, randomized, double-blind, placebo controlled Phase Ⅲ trial; including 3 stages: screening period, treatment period, and follow-up period.

  • Screening period: 6 weeks prior to treatment
  • Treatment period:
  • Induction period: APL-1202 is administered for 12 consecutive weeks
  • Maintenance period: after 12-week drug free period, APL-1202 is administered for another12 consecutive weeks as maintenance treatment
  • Follow up period: APL-1202 is administered at every 3-month interval if no events occurred in the treatment period and until the occurrence of events or the end of the entire clinical trial Intravesical Epirubicin hydrochloride will be administered once weekly for consecutive 6-8 weeks in the induction period, followed by once monthly in the maintenance period until end of 12 months
Being tested
APL-1202 in combination with Epirubicin, Placebo in combination with Epirubicin
Medical subject headings
Non-Muscle Invasive Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • APL-1202 in combination with EpirubicinDrug

    • Induction period: APL-1202 is administered for 12 consecutive weeks
    • Maintenance period: after 12-week drug free period, APL-1202 is administered for another12 consecutive weeks as maintenance treatment
    • Follow up period: APL-1202 is administered at every 3-month interval if no events occurred in the treatment period and until the occurrence of events or the end of the entire clinical trial Intravesical Epirubicin hydrochloride will be administered once weekly for consecutive 6-8 weeks in the induction period, followed by once monthly in the maintenance period until end of 12 months

  • Placebo in combination with EpirubicinDrug

    • Induction period: placebo is administered for 12 consecutive weeks
    • Maintenance period: after 12-week drug free period, placebo is administered for another12 consecutive weeks as maintenance treatment
    • Follow up period: APL-1202 is administered at every 3-month interval if no events occurred in the treatment period and until the occurrence of events or the end of the entire clinical trial Intravesical Epirubicin hydrochloride will be administered once weekly for consecutive 6-8 weeks in the induction period, followed by once monthly in the maintenance period until end of 12 months
Study groups in NCT04490993
Study groupRoleWhat they receive
APL-1202 treatmentExperimentalNot described
Receives: Drug: APL-1202 in combination with Epirubicin
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo in combination with Epirubicin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Event-free survival

    "Event"is defined as: pathologically confirmed recurrence, progression, or death resulting from bladder cancer

    Measured: Up to 30 months

Secondary outcomes (6)

  1. Recurrent-free rate

    Recurrent-free rate

    Measured: 24 months

  2. Progression-free rate

    Progression-free rate

    Measured: 24 months

  3. Clinical benefit rate at 12,18, 24 months after enrollment (clinical benefits are defined as the pathological improvement of the recurrence, no high-risk recurrence, progression-free recurrence, no radical therapy and no death)

    Clinical benefit rate at 12,18, 24 months after enrollment (clinical benefits are defined as the pathological improvement of the recurrence, no high-risk recurrence, progression-free recurrence, no radical therapy and no death)

    Measured: 24 months

  4. Recurrence-free survival

    Recurrence-free survival

    Measured: Up to 30 months

  5. Progression-free survival

    Progression-free survival

    Measured: Up to 30 months

  6. Total survival

    Total survival

    Measured: Up to 30 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2020
  2. Study start30 Mar 2017
  3. Primary completion30 May 2022 (estimated)
  4. Study completion30 May 2022 (estimated)

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
359 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04490993
Sponsor's protocol ID
YHCT-NIT-R1
Acronym
ACCRUE
Status last verified
Feb 2022
First submitted
23 Jul 2020
Last updated
22 Feb 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing APL-1202 in combination with Epirubicin in people with Non-muscle Invasive Bladder Cancer, run by Jiangsu Yahong Meditech Co., Ltd aka Asieris at 1 site in China.

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 13 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 22 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

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?

Event-free survival (time frame: Up to 30 months). 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 NCT04490993.

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 22 Feb 2022.

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