Clinical Trials Logo

Clinical Trial Summary

This phase I trial studies the side effects and best dose of veliparib when given together with liposomal irinotecan in treating patients with solid tumors. Liposomal irinotecan and veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.


Clinical Trial Description

PRIMARY OBJECTIVES: I. To evaluate the safety and tolerability of escalating doses of liposomal irinotecan (MM-398) + veliparib combination. II. To determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of the combination of MM-398 + veliparib. SECONDARY OBJECTIVES: I. To observe and record anti-tumor activity. II. To characterize the preliminary efficacy of the combination using key efficacy indicators, such as objective response rate, clinical benefit rate defined as complete response (CR), partial response (PR), or stable disease (SD) at 24 weeks, and progression free survival (PFS). EXPLORATORY OBJECTIVE: I. Imaging, tumor, and blood biomarkers to assess the sensitivity or resistance to each drug and/or correlation with clinical response. OUTLINE: This is a dose-escalation study of veliparib. Patients receive liposomal irinotecan intravenously (IV) over 90 minutes on days 1 and 15 and veliparib orally (PO) twice daily (BID) on days 5-12 and 19-25 or 3-12 and 17-25. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Within 2-6 days prior to beginning liposomal irinotecan treatment, patients may optionally receive ferumoxytol (FMX) IV and undergo magnetic resonance imaging (MRI) at baseline and 24 hours after FMX infusion. After completion of study treatment, patients are followed up for 4 weeks. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02631733
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Active, not recruiting
Phase Phase 1
Start date May 31, 2017
Completion date July 1, 2024

See also
  Status Clinical Trial Phase
Recruiting NCT06030427 - Virtual Mindfulness and Weight Management to Mitigate Risk of Relapse and Improve Wellbeing in Cancer Survivors N/A
Completed NCT04337203 - Shared Healthcare Actions and Reflections Electronic Systems in Survivorship N/A
Recruiting NCT05660421 - Itacitinib for the Treatment Steroid Refractory Immune Related Adverse Events Arising From Immune Checkpoint Inhibitors Phase 2
Suspended NCT04060849 - Nozin in Preventing Respiratory Viral Infections in Patients Undergoing Stem Cell Transplant, PREV-NOSE STUDY Phase 1
Recruiting NCT06192875 - A Novel Molecular Approach to Blood DNA Screening for Cancer: Specificity Assessment (The NOMAD Study)
Completed NCT04122118 - Pharmacist-led Transitions of Care in the Outpatient Oncology Infusion Center for Patients With Solid Tumor N/A
Active, not recruiting NCT04940299 - Tocilizumab, Ipilimumab, and Nivolumab for the Treatment of Advanced Melanoma, Non-Small Cell Lung Cancer, or Urothelial Carcinoma Phase 2
Active, not recruiting NCT03168737 - 18F-Fluoroazomycin Arabinoside PET-CT in Diagnosing Solid Tumors in Patients Phase 1
Active, not recruiting NCT06062901 - An Educational Intervention on Provider Knowledge for the Support of Cancer Survivors N/A
Active, not recruiting NCT02444741 - Pembrolizumab and Stereotactic Body Radiation Therapy or Non-Stereotactic Wide-Field Radiation Therapy in Treating Patients With Non-small Cell Lung Cancer Phase 1/Phase 2
Terminated NCT04081298 - eHealth Diet and Physical Activity Program for the Improvement of Health in Rural Latino Cancer Survivors N/A
Active, not recruiting NCT04555837 - Alisertib and Pembrolizumab for the Treatment of Patients With Rb-deficient Head and Neck Squamous Cell Cancer Phase 1/Phase 2
Completed NCT04983901 - PHASE II SINGLE-CENTER, RANDOMIZED, OPEN-LABEL, PROSPECTIVE, STUDY TO DETERMINE THE IMPACT OF SERIAL PROCALCITONIN Phase 2
Active, not recruiting NCT04602026 - The RIOT Trial: Re-Defining Frailty and Improving Outcomes With Prehabilitation for Pancreatic, Liver, or Gastric Cancer N/A
Recruiting NCT04871542 - Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Active, not recruiting NCT04592250 - Financial Toxicity in Cancer Patients
Recruiting NCT05112614 - Role of Gut Microbiome in Cancer Therapy
Active, not recruiting NCT04296305 - Effect of Opioid Infusion Rate on Abuse Liability Potential of Intravenous Hydromorphone for Cancer Pain Phase 4
Recruiting NCT05873608 - Communication Issues in Patient and Provider Discussions of Immunotherapy N/A
Recruiting NCT02464696 - Non-invasive Ventilation in Reducing the Need for Intubation in Patients With Cancer and Respiratory Failure N/A