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Non-Muscle Invasive Bladder Cancer (NMIBC)Phase 1/2NMIBCNCT03672240

Study of APL-1202 in Non-Muscle Invasive Bladder Cancer Patients Who Are Resistant to One Induction Course of BCG Treatment

A Phase 1/2 study testing APL-1202 in people with Non-Muscle Invasive Bladder Cancer (NMIBC), run by Asieris Pharmaceutical Technologies Co., Ltd. at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A Phase Ib, open label, non randomized study to measure the safety and PK characteristics of APL-1202 at steady-state in adult male and female BCG resistant NMIBC patients when it is administered alone and concurrently with BCG. Read more about this study

Who is it for?
Ages 18 to 99 years
What is being tested?
APL-1202
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
2 sitesUnited States
Study dates
30 Nov 2018to 30 Jun 2020
Phase
Phase 1/2
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 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • History of Intermediate Risk or High Risk Transitional Cell Carcinoma Non-Muscle Invasive Bladder Cancer as defined by AUA Guidelines:
  • AUA Risk Stratification for Non-Muscle Invasive Bladder Cancer
  • Low Risk LGa solitary Ta ≤ 3cm PUNLMPb
  • Intermediate Risk Recurrence within 1 year Solitary LG Ta > 3cm LG Ta, multifocal HGc Ta, ≤ 3cm LG T1
  • High Risk HG T1 Any recurrent, HG Ta HG Ta, >3cm (or multifocal) Any CISd Any BCG failure in HG patient Any variant histology Any LVIe Any HG prostatic urethral
  • LG = low grade; b. PUNLMP = papillary urothelial neoplasm of low malignant potential; c. HG = high grade; d. CIS=carcinoma in situ; e. LVI = lymphovascular invasion.
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  • History of prior induction course of intravesical BCG, using 1/3 to full dose of BCG for 6 treatments (BCG Naïve will not be eligible). Previous BCG treatment in combination with interferon is allowed.
  • Patients who are eligible will either receive maintenance course (3 treatments 1/3 to full dose) or repeat induction course (6 treatments 1/3 to full dose)
  • Principal Investigator's discretion if patients who have a negative cystoscopy or urine cytology following initial BCG induction, can be placed on maintenance BCG to recurrence of bladder cancer
  • 18 years of age or older
  • Eastern Cooperative Oncology Group (ECOG) performance status < 2
  • Not pregnant or lactating
  • Subjects with child bearing or fathering potential must agree to use adequate contraception during the study and for 3 months after last treatment of investigational drug
  • Agree to study specific informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information
  • Adequate baseline complete blood count (CBC), renal and hepatic function:
  • 1) Parameters described as WBC > 3000 cells/mm3, ANC > 1,000 cells/mm3, hemoglobin > 8.5 g/dL, and platelet count >100,000 cells/mm3 2) Adequate renal function: serum creatinine < 1.5 x upper limit of normal (ULN) 3) Bilirubin, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) are not more than 2 x Upper Limits of Normal 4) Absolute lymphocyte count ≥ 800/μL before the first dose of APL-1202

Who cannot join

  • Stage T2 or above urothelial carcinoma or urothelial carcinoma outside the bladder
  • Stage T1 NMIBC recurred at 3 months or shorter from the first dose of prior induction BCG course
  • Recurrent high-grade Ta/T1 disease within 6 months from the last dose of adequate BCG therapy
  • Previous systemic immunotherapy for bladder cancer
  • Prior major surgery (not Transurethral Resection of Bladder Tumor [TURBT/Cystoscopy]), radiation therapy, or systemic therapy within 8 weeks of starting the study treatment
  • National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) Grade 3 hemorrhage within four weeks from the starting study treatment
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  • Any of the following medical conditions within the six months prior to investigational 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
  • Optic nerve disorders or with a history of optic nerve disorders
  • Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or investigational drug administration, or may interfere with the interpretation of study results in the judgment of the Investigator
  • Clinically meaningful allergic reactions or any known hypersensitivity or prior reaction to any of the formulation components in the investigational drug
  • Systemic treatment on any investigational clinical trial within 28 days (or 5 half-lives of that agent, whichever is greater) prior to enrollment
  • Concurrent treatment with immunosuppressive or immunomodulatory agents, including any systemic steroid (exception: inhaled or topically applied steroids, and acute and chronic standard dose nonsteroidal anti-inflammatory drugs (NSAIDs), are permitted). Use of a short course (i.e., ≤ 2 day) of a glucocorticoid is acceptable to prevent a reaction to the IV contrast used for: computed tomography (CT) scans
  • Immunosuppressive therapy, including: cyclosporine, anti-thymocyte globulin, or tacrolimus within three months of study entry
  • Concurrent treatment with strong inducers or inhibitors of CYP450 enzymes
  • Concurrent treatment with low therapeutic index drugs (such as methotrexate) that are renally cleared by OAT1- and OAT3-mediated transport
  • History of prior malignancy, except for adequately treated in situ cancer or basal cell or squamous cell skin cancer or other cancers (e.g. breast, prostate) for which the patient has been disease free and/or received curative therapy. Exclusion of patients described above will be at the discretion of the Sponsor.
  • Progressive or persistent viral or bacterial infection
  • All infections must be resolved, and the subject must remain afebrile for seven days without antibiotics prior to enrollment
  • Urinary tract infection, including particularly bladder infection, must be resolved prior to being placed on study
  • Unmanageable active gastric ulcer or inflammation of gastrointestinal (GI) tract
  • Gastric bleeding within last 6 months prior to enrollment
  • Anuria
  • Unable to take oral medication
  • Unwilling or unable to comply with the protocol or cooperate fully with the Investigator and site personnel
  • Unwilling to sign the informed consent

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolina, 29572

  • The Icahn School of Medicine at Mt. Sinai

    New York, New York, 10029

Other trials in United States

About this study

Official title: A Phase Ib Study of APL-1202 in NMIBC Patients Who Are Resistant to One Induction Course of BCG Treatment

A Phase Ib, open label, non randomized study to measure the safety and PK characteristics of APL-1202 at steady-state in adult male and female BCG resistant NMIBC patients when it is administered alone and concurrently with BCG.

Read the detailed description

Six eligible participants will be administered with APL-1202 one week prior to the first BCG instillation, during the six-week course of BCG instillation, and additional five weeks, for a total of 12 weeks of dosing. Safety assessment will be performed during the entire 13 week study duration. Plasma and urine samples will be collected from each participant at prior to first and fifth BCG instillations for PK analysis.

Being tested
APL-1202
Keywords
Urinary Bladder Neoplasms, Non-Muscle Invasive Bladder Cancer (NMIBC), Oral Antineoplastic Agent
Medical subject headings
Non-Muscle Invasive Bladder Neoplasms, Urinary Bladder Neoplasms

What participants receive

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

  • APL-1202Drug

    To assess the safety and pharmacokinetics of APL-1202 alone and in combination with Bacillus Calmette Guerin

Study groups in NCT03672240
Study groupRoleWhat they receive
APL-1202Experimental* APL-1202 will be administered orally at daily 750 mg (250 mg, TID) for 5-7 days prior to the first intravesical BCG treatment and continue for additional 11 weeks (a total 12 weeks of dosing with APL-1202). * Standard intravesical BCG induction course (once weekly for 6 weeks) 50 mg TICE BCG in 50 mL sterile saline (or a full dose standard vial of BCG) will be initiated on Week 2.
Receives: Drug: APL-1202

What is being measured

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

  1. Incidence and Severity of Treatment-Related Adverse Events

    Incidence and Severity of Treatment-Related Adverse Events as Assessed by CTCAE v.5.0 or newer

    Measured: 13 weeks

Secondary outcomes (10)

  1. Pharmacokinetics - Area Under Curve

    PK measurement expressed as area under curve for APL-1202

    Measured: On Week 2 prior to first BCG instillation

  2. Pharmacokinetics - Area Under Curve

    PK measurement expressed as area under curve for APL-1202

    Measured: On Week 6 prior to fifth BCG instillation

  3. Pharmacokinetics - Maximum Plasma Concentration

    PK measurement expressed as maximum plasma concentration for APL-1202

    Measured: On Week 2 prior to first BCG instillation

  4. Pharmacokinetics - Maximum Plasma Concentration

    PK measurement expressed as maximum plasma concentration for APL-1202

    Measured: On Week 6 prior to fifth BCG instillation

  5. Pharmacokinetics - Half-Life

    PK measurement expressed as half-life for APL-1202

    Measured: On Week 2 prior to first BCG instillation

  6. Pharmacokinetics - Half-Life

    PK measurement expressed as half-life for APL-1202

    Measured: On Week 6 prior to fifth BCG instillation

  7. Pharmacokinetics - Cumulative Amount in Urinary Excretion

    PK measurement expressed as cumulative amount in urinary excretion for APL-1202

    Measured: Eight hours after first dose on Week 2 prior to first BCG instillation

  8. Pharmacokinetics - Cumulative Amount in Urinary Excretion

    PK measurement expressed as cumulative amount in urinary excretion for APL-1202

    Measured: Eight hours after first dose on Week 6 prior to fifth BCG instillation

  9. Pharmacokinetics - Cumulative Fraction of Dose in Urinary Excretion

    PK measurement expressed as cumulative fraction of dose in urinary excretion for APL-1202

    Measured: Eight hours after first dose on Week 2 prior to first BCG instillation

  10. Pharmacokinetics - Cumulative Fraction of Dose in Urinary Excretion

    PK measurement expressed as cumulative fraction of dose in urinary excretion for APL-1202

    Measured: Eight hours after first dose on Week 6 prior to fifth BCG instillation

Timeline

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

  1. First posted14 Sep 2018
  2. Study start30 Nov 2018
  3. Primary completion30 Oct 2019
  4. Study completion30 Jun 2020

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03672240
Sponsor's protocol ID
YHGT-NB-01
Acronym
NMIBC
Status last verified
Jul 2020
First submitted
5 Sep 2018
Last updated
20 Jul 2020
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 1/2 study testing APL-1202 in people with Non-Muscle Invasive Bladder Cancer (NMIBC), run by Asieris Pharmaceutical Technologies Co., Ltd. at 2 sites in United States.

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 16 inclusion and 26 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 20 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Incidence and Severity of Treatment-Related Adverse Events (time frame: 13 weeks). 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 NCT03672240.

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 20 Jul 2020.

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