Phase
Condition
Neoplasms
Treatment
Talazoparib
Gemcitabine Injection
RP-3500 (camonsertib)
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Written informed consent, according to local guidelines, signed and dated by thepatient or legal guardian prior to the performance of any study-specific procedures,sampling, or analyses.
Male or female and ≥ 18 years-of-age at the time of signature of the consent.
Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
Histologically confirmed solid tumors resistant or refractory to standard treatmentand/or patients who are intolerant to standard therapy.
Measurable disease as per RECIST v1.1
Existing biomarker profile (tumor tissue or plasma) reported from a local testobtained in a certified lab per institutional guidelines:
Available tumor tissue
Ability to comply with the protocol and study procedures detailed in the Schedule ofAssessments.
Ability to swallow and retain oral medications.
Acceptable organ function at screening
Acceptable blood counts at screening
Negative pregnancy test (serum or urine) for females of childbearing potential atScreening and prior to first study drug.
Resolution of all toxicities of prior treatment or surgery.
Male patients with female partners of childbearing potential and females ofchildbearing potential must follow a contraception method (oral contraceptivesallowed) during their participation in the study and for at least 6 months followinglast dose of study drug. Male patients must also refrain from donating sperm duringtheir participation in the study and for 6 months following last dose of study drug.
Exclusion
Exclusion Criteria:
Chemotherapy, small molecule anticancer or biologic anticancer therapy given within 14 days prior to first dose of study drug.
History or current condition (such as transfusion dependent anemia orthrombocytopenia), therapy, or laboratory abnormality that might confound the studyresults, or interfere with the patient's participation for the full duration of thestudy treatment.
Prior therapy with an ATR or DNA-dependent protein kinase (DNA-PK) inhibitor.
Known hypersensitivity to any of the ingredients of RP-3500 (camonsertib).
Life-threatening illness, medical condition, active uncontrolled infection, or organsystem dysfunction or other reasons which, in the investigator's opinion, couldcompromise the patient's safety.
Uncontrolled, symptomatic brain metastases.
Uncontrolled high blood pressure
Patients with active, uncontrolled bacterial, fungal, or viral infection, includinghepatitis B virus (HBV), hepatitis C virus (HCV), known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related illness.
Moderate or severe hepatic impairment (ie, Child-Pugh class B or C).
History or presence of an abnormal ECG that is clinically significant in theinvestigator's opinion.
History of ventricular dysrhythmias or risk factors such as structural heartdisease, coronary heart disease (clinically significant electrolyte abnormalities orfamily history of sudden unexplained death or long QT syndrome
Current treatment with medications that are well-known to prolong the QT interval
History of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) diagnosis
Study Design
Study Description
Connect with a study center
Participating Site 2001
Toronto, Ontario M5G 2M9
CanadaSite Not Available
#2001, Princess Margaret Cancer Centre
Toronto 6167865, Ontario 6093943 M5G 2M9
CanadaSite Not Available
Participating Site 4001
Copenhagen, DK 2100 Ø
DenmarkSite Not Available
#4001, Copenhagen University Hospital Rigshospitalet - Blegdamsvej
Copenhagen 2618425, DK 2100 Ø
DenmarkSite Not Available
Participating Site 3003
London, W1G 6AD
United KingdomSite Not Available
#3003, Sarah Cannon Research Institute
London 2643743, W1G 6AD
United KingdomSite Not Available
Participating Site 3001
Manchester, M20 4BX
United KingdomSite Not Available
#3001, The Christie NHS Foundation Trust
Manchester 2643123, M20 4BX
United KingdomSite Not Available
Participating Site 3002
Newcastle Upon Tyne, NE7 7DN
United KingdomSite Not Available
#3002, Freeman Hospital Newcastle
Newcastle upon Tyne 2641673, NE7 7DN
United KingdomSite Not Available
Participating Site 1014
Chicago, Illinois 60611
United StatesSite Not Available
#1014, Northwestern University
Chicago 4887398, Illinois 4896861 60611
United StatesSite Not Available
Participating Site 1002
Boston, Massachusetts 02215
United StatesSite Not Available
Participating Site 1006
Boston, Massachusetts 02114
United StatesSite Not Available
#1002, Dana Farber Cancer Institute
Boston 4930956, Massachusetts 6254926 02215
United StatesSite Not Available
#1006, Massachusetts General Hospital
Boston 4930956, Massachusetts 6254926 02114
United StatesSite Not Available
Participating Site 1004
New York, New York 10065
United StatesSite Not Available
#1004, Memorial Sloan Kettering Cancer Institute
New York 5128581, New York 5128638 10065
United StatesSite Not Available
Participating Site 1005
Durham, North Carolina 27710
United StatesSite Not Available
#1005, Duke Cancer Institute
Durham 4464368, North Carolina 4482348 27710
United StatesSite Not Available
Participating Site 1007
Providence, Rhode Island 02903
United StatesSite Not Available
#1007, Rhode Island Hospital
Providence 5224151, Rhode Island 5224323 02903
United StatesSite Not Available
Participating Site 1003
Nashville, Tennessee 37203
United StatesSite Not Available
#1003, Sarah Cannon Research Institute
Nashville 4644585, Tennessee 4662168 37203
United StatesSite Not Available
Participating Site 1001
Houston, Texas 77030
United StatesSite Not Available
#1001, The University of Texas M.D. Anderson Cancer Center
Houston 4699066, Texas 4736286 77030
United StatesSite Not Available
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