2-[4-[4-(AMINOMETHYL)-1-OXO-2H-PHTHALAZIN-6-YL]-2-METHYLPYRAZOL-3-YL]-4-CHLORO-6-CYCLOPROPYLOXY-3-FLUOROBENZONITRILE for Metastatic pancreatic ductal adenocarcinoma

Inclusion criteria

• {"criterion_text":"- Histologically or cytologically confirmed diagnosis of metastatic PDAC"}
• {"criterion_text":"- Evidence of homozygous MTAP deletion or MTAP loss detected in tumor tissue"}
• {"criterion_text":"- Metastatic disease with at least 1 measurable lesion as per RECIST v1.1"}
• {"criterion_text":"- Participants must not have received any systemic anticancer treatments in the metastatic setting (participants may receive up to one cycle of standard of care nab-p/gem prior to randomization)"}
• {"criterion_text":"- Participants must be >18 years of age at the time of signing consent"}

Exclusion criteria

• {"criterion_text":"- Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to screening"}
• {"criterion_text":"- Participants must not have an impairment in gastrointestinal function that may limit the ability to absorb or swallow an oral medication without chewing or crushing"}
• {"criterion_text":"- Participants must not have significant cardiovascular abnormalities or conditions withing 6 months prior to enrollment"}
• {"criterion_text":"- Confirmed and active viral infections including hepatitis and/or HIV"}

Primary endpoints

• {"endpoint_text":"- Time to disease worsening on scans and time to death (Phase 3)","definition_or_measurement_approach":"Measured as time to radiographic disease worsening on imaging (scans) and overall survival (time to death); a time-to-event endpoint based on imaging assessments and survival data (specific assessment schedule/method not detailed in the record)."}

Secondary endpoints

• {"endpoint_text":"- Rate of tumor shrinkage, duration of tumor shrinkage, time to tumor shrinkage, and rate of participants with control of tumor growth and/or shrinkage","definition_or_measurement_approach":"Tumor response metrics measured by tumor assessments (imaging) including rate, duration and time to shrinkage, and proportion of participants with tumor control/shrinkage (specific assessment criteria/schedule not detailed in the record)."}

Methods

• Patient recruitment duties assigned to third-party organization Massive Bio Inc. (role listed as 'Patient recruitment') - channels not specified in record.
• Country-specific recruitment materials listed in the documents: posters, brochures, patient one-sheeter, doctor-to-patient email and doctor-to-patient letter (e.g., K2_Recruitment materials_Poster, _Brochure, _Patient One Sheeter, _Doctor to Patient Email) - country-specific versions available (examples in Austria, Germany, Ireland, etc.).
• Recruitment arrangements documents (K1) provided per country (e.g., K1_Recruitment arrangements_DE, K1_Recruitment arrangements_FR, K1_Recruitment arrangements_IE) indicating planned local recruitment arrangements though the record does not provide the document contents.

Primary sponsor

Full Name

Bristol-Myers Squibb Services Unlimited Company

Organisation Type

Pharmaceutical company

Country Of Registered Address

Ireland

Contract research organisations

Name

Clario

Responsibilities

Medical image analysis/review - X-ray, MRI, ultrasound; Customer Care / Site Logistics / Training / Equipment Customization

Name

Endpoint Clinical Inc.

Responsibilities

IVRS – treatment randomisation; Subject Number Assignment; Treatment/Arm Assignment; Drug (re)Supplies Assignment

Name

Accenture Services Pvt. Ltd.

Responsibilities

Pharmacovigilance duties: Medical review and Cases Data Entry

Third parties

• {"country":"United States","full_name":"Massive Bio Inc.","duties_or_roles":"Patient recruitment","organisation_type":"Pharmaceutical company"}
• {"country":"India","full_name":"Accenture Services Pvt. Ltd.","duties_or_roles":"Pharmacovigilance duties: Medical review and Cases Data Entry","organisation_type":"SME"}
• {"country":"Germany","full_name":"Azenta Germany GmbH","duties_or_roles":"Sample storage","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Clario","duties_or_roles":"Medical image analysis/ review - X-ray, MRI, ultrasound, Customer Care / Site Logistics / Training / Equipment Customization","organisation_type":"Industry"}
• {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"Routine clinical pathology testing, Clinical chemistry, Clinical haematology, Clinical microbiology, IHC Biomarker expression analysis (PD-L1), other APH","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Discovery Life Sciences LLC","duties_or_roles":"DNA and RNA isolation from FFPE tumor samples as well as whole transcriptome sequencing","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"India","full_name":"Accenture Solutions Private Limited","duties_or_roles":"Embarc operations","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Labcorp Central Laboratory Services","duties_or_roles":"PK analysis","organisation_type":"Health care"}
• {"country":"United States","full_name":"Endpoint Clinical Inc.","duties_or_roles":"IVRS – treatment randomisation; Subject Number Assignment, Treatment/Arm Assignment, Drug (re) Supplies Assignment","organisation_type":"Health care"}
• {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Provides electronic payments, travel arrangements, electronic study-related communications to patients","organisation_type":"Non-Pharmaceutical company"}