Tumor-Agnostic Precision Immuno-Oncology and Somatic Targeting Rational for You (TAPISTRY) Platform Study

JRCT ID: jRCT2031210670

Registered date:17/03/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: RET fusion-positive solid tumors other than NSCLC
• Date of first enrollment: 14/09/2022
• Target sample size: 770
• Countries of recruitment: Australia,Japan,Belgium,Japan,Brazil,Japan,Canada,Japan,China,Japan,Denmark,Japan,France,Japan,Germany,Japan,Hong Kong,Japan,Israel,Japan,Italy,Japan,Republic of Korea,Japan,Netherlands,Japan,New Zealand,Japan,Poland,Japan,Portugal,Japan,Puerto Rico,Japan,Singapore,Japan,Spain,Japan,Switzerland,Japan,Taiwan,Japan,United Kingdom,Japan,United States,Japan
• Study type: Interventional
• Intervention(s): Pralsetinib: a continuous daily dosing regimen at a dose of 400 mg/day orally

Outcome(s)

Primary Outcome

Efficacy
Independent Review Committee (IRC)-assessed objective response rate (ORR) based on confirmed (>= 4 weeks after initial documentation of response) objective response (per RECIST v1.1)

Secondary Outcome

Safety, Efficacy, Phamacokinetics
-IRC-assessed DOR, clinical benefit rate(CBR), and PFS
-Investigator (INV)-assessed ORR, DOR, CBR, and PFS
-IRC- and INV-assessed time to CNS progression
-Overall Survival
-IRC / INV-assessed CNS-ORR, CNS-DOR, CNS-CBR, and CNS-PFS per RANO
-IRC / INV-assessed ORR, DOR, CBR, and PFS per INRC
-IRC / INV-assessed ORR in patients with RET fusion positive ctDNA by blood-based NGS assay
-IRC / INV-assessed intracranial (IC)-ORR, IC-DOR, IC-CBR, IC-PFS rate
-Percentage of participants with confirmed deterioration, change from baseline, percentage of participants with a clinical meaningful change on the Global Health Status, Physical Functioning, and Role Functioning scores as assessed by the EORTC QLQ-C30
-Descriptive endpoint of time to confirmed symptom onset or worsening from tumor-related symptom scores from the EORTC QLQ-C30
-Adverse events
-Plasma concentration of drug

Key inclusion & exclusion criteria

• Age minimum: >= 12age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

-Histologically or cytologically confirmed diagnosis of advanced and unresectable or metastatic solid malignancy
-Measurable disease as defined by Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1), Response Assessment in Neuro-Oncology (RANO) criteria, or International Neuroblastoma Response Criteria (INRC)
-Performance status as follows: Participantss aged >= 18 years: Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2; Participantss aged 16 to < 18 years: Karnofsky score >= 50%; Participants aged < 16 years: Lansky score >= 50%
-For participants aged >= 18 and <18 years: adequate hematologic and end-organ function
-Disease progression on prior treatment, or previously untreated disease with no available acceptable treatment
-Adequate recovery from most recent systemic or local treatment for cancer
-Life expectancy >= 8 weeks
-Ability to comply with the study protocol, in the investigator's judgment
-RET fusion positivity, as determined by a Clinical Laboratory Improvement Amendments or equivalently certified next generation sequencing (NGS) assay (tissue or blood).
-Ability to swallow pralsetinib intact, without chewing, crushing, or opening the capsules
-For females of childbearing potential: Negative pregnancy test <= 7 days prior to initiating study treatment; agreement to remain abstinent (refrain from heterosexual intercourse) or use single or combined non-hormonal contraception methods that result in a failure rate of <1% per year during the treatment period and for at least 14 days after the last dose of pralsetinib; and agreement to refrain from donating eggs during this same period
Examples of non-hormonal contraceptive methods with a failure rate of < 1% per year include bilateral tubal ligation, male sterilization, and copper intrauterine devices.
-For males: Agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom plus an additional contraception method that together result in a failure rate of <1% per year during the treatment period and for at least 7 days after the last dose of pralsetinib, and agreement to refrain from donating sperm during this same period

Exclude criteria

-Current participation or enrollment in another therapeutic clinical trial
-Any anticancer treatment within 2 weeks prior to start of study treatment
-Whole brain radiotherapy within 14 days prior to start of study treatment
-Stereotactic radiosurgery within 7 days prior to start of study treatment
-Pregnant or breastfeeding, or intending to become pregnant during the study
-History of or concurrent serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the participant's safe participation in and completion of the study or confounds the ability to interpret data from the study
-Incomplete recovery from any surgery prior to the start of study treatment that would interfere with the determination of safety or efficacy of study treatment
-Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or higher), myocardial infarction, or cerebrovascular accident within 3 months prior to enrollment, unstable arrhythmias, or unstable angina
-History of another active cancer within 5 years prior to screening that may interfere with the determination of safety or efficacy of study treatment with respect to the qualifying solid tumor malignancy
-Diagnosis of RET fusion positive NSCLC
-Prior treatment with RET inhibitors (approved or investigational)
-Symptomatic or actively progressing CNS metastases
Asymptomatic patients with treated or untreated CNS metastases are eligible, provided that all of the following criteria are met:
-No ongoing requirement for corticosteroids as therapy for CNS metastases
-No evidence of interim progression between the completion of CNS-directed therapy and screening radiographic study
-No history of intracranial hemorrhage or spinal cord hemorrhage
-Clinically symptomatic interstitial lung disease or interstitial pneumonitis, including radiation pneumonitis (i.e., affecting activities of daily living or requiring therapeutic intervention)
-History of pneumonitis during the prior 12 months
-Ongoing treatment with chronic immunosuppressants (e.g., cyclosporine) or systemic steroids > 10 mg/day of prednisone (or equivalent)
-Active, uncontrolled infection (viral, bacterial, or fungal)
-Have a positive hepatitis C virus (HCV) antibody test at screening
Patients positive for HCV antibody are eligible only if PCR is negative for HCV RNA.
-Have a positive hepatitis B surface antigen (HBsAg) test at screening
Patients with past hepatitis B virus (HBV) infection or resolved HBV infection (hepatitis B core antibody [HBcAb] positive, but negative HBsAg) are eligible only if the HBV DNA test is negative.
-Have a positive HIV test at screening, with the following exception:
Patients with a positive HIV screening are eligible provided they are on stable antiretroviral therapy, have a CD4 count >= 200/uL, and have an undetectable viral load.
Sites should include an HIV test during screening, as allowed per local regulations.

Related Information

• Primary Sponsor: David Chen
• Secondary ID(s): NCT04589845