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
Participating Site 4001
Copenhagen, DK 2100 Ø
DenmarkSite Not Available
Participating Site 3003
London, W1G 6AD
United KingdomSite Not Available
Participating Site 3001
Manchester, M20 4BX
United KingdomSite Not Available
Participating Site 3002
Newcastle Upon Tyne, NE7 7DN
United KingdomSite Not Available
Participating Site 1014
Chicago, Illinois 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
Participating Site 1004
New York, New York 10065
United StatesSite Not Available
Participating Site 1005
Durham, North Carolina 27710
United StatesSite Not Available
Participating Site 1007
Providence, Rhode Island 02903
United StatesSite Not Available
Participating Site 1003
Nashville, Tennessee 37203
United StatesSite Not Available
Participating Site 1001
Houston, Texas 77030
United StatesSite Not Available
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