Status:
UNKNOWN
Niraparib Combined With Anlotinib in Homologous Recombination Repair (HRR) Gene-mutated Advanced Solid Tumors
Lead Sponsor:
Peking University Cancer Hospital & Institute
Conditions:
HER2-negative Breast Cancer
Gastric Adenocarcinoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
Homologous Recombination Repair (HRR) gene mutations can be detected in many solid tumors, patients with HRR gene mutations may benefit from PARP inhibitor. Antiangiogenic drugs can induce hypoxia and...
Detailed Description
This is a single-arm, single-center, phase I study to investigate the DLT and MDT, safety and efficacy of Niraparib combined with Anlotinib in the treatment of advanced solid tumors with HRR gene muta...
Eligibility Criteria
Inclusion
- Subjects understand the trial process, sign informed consent, agree to participate in the study, and have the ability to follow the protocol;
- 18 \~ 70 years old
- HER2 negative breast cancer, cholangiocarcinoma, gastric adenocarcinoma and pancreatic cancer confirmed by histology or cytology meet any of the following conditions: first line treatment failure of HER2 negative breast cancer; first line treatment failure of cholangiocarcinoma; second line treatment failure of gastric adenocarcinoma; first line treatment failure of pancreatic cancer
- At least one measurable target lesion that meet RECIST 1.1 criteria
- Can provide paraffin-embedded tumor tissue samples or plasma samples for HRR gene detection
- Carry pathogenic or suspected pathogenic germline or somatic HRR gene mutations, HRR genes include BRCA1, BRCA2, ATM, ATR, BAP1, BRIP1, CHEK2, FANCA, PALB2 and RAD51, mutations in other HRR genes should be evaluated by researchers and the pathogenicity should be supported by published literature or clinical studies.
- ECOG physical status score is 0-1
- Life expectancy \> 6 months
- Good organ function, including: Neutrophil count \>= 1500 / μL; Platelets \>= 100,000 / μL; Hemoglobin \>= 10g / dL; Serum creatinine \<= 1.5 times the upper limit of normal value, or creatinine clearance \>= 60mL / min (calculated according to Cockcroft-Gault formula); Total bilirubin \<= 1.5 times the upper limit of normal value or direct bilirubin \<= 1.0 times the upper limit of normal value; AST and ALT \<= 2.5 times the upper limit of normal value. When liver metastases are present, it must be \<= 5 times the upper limit of normal value
- The toxic side effects of any previous chemotherapy have recovered to \<= CTCAE level 1 or baseline levels, except for sensory neuropathy or hair loss with stable symptoms \<= CTCAE level 2
Exclusion
- People who are known to be allergic to Niraparib or Anlotinib (or active or inactive ingredients of drugs with similar chemical structure)
- Symptomatic, uncontrolled brain or pia mater metastases
- Underwent major surgery within 3 weeks before the study began or has not recovered after surgery
- Received palliative radiotherapy of \> 20% bone marrow 1 week before enrollment
- Have invasive cancer other than ovarian cancer (except fully treated basal or squamous cell skin cancer) within 2 years before enrollment
- Patients with tumor invasion of large vessels
- Previous or currently diagnosed myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML)
- Severe or uncontrolled diseases, including but not limited to: uncontrollable nausea and vomiting, inability to swallow or gastrointestinal diseases that may interfere with drug absorption and metabolism; active viral infections; mental illnesses that affect patients' signed informed consent History of bleeding tendency and thrombosis; history of severe cardiovascular disease
- Laboratory abnormalities: hyponatremia; hypokalemia; uncontrollable nail function abnormalities
- Receive platelet or red blood cell transfusions within 4 weeks
- Patients who are pregnant or nursing, or who plan to become pregnant during study treatment
- Have previously received any PARP inhibitor or Anlotinib treatment
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2023
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT04764084
Start Date
April 1 2021
End Date
February 28 2023
Last Update
February 21 2021
Active Locations (1)
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1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142