Combination Therapy With NC-6004 and Gemcitabine in Advanced Solid Tumors or Non-Small Cell Lung, Biliary and Bladder Cancer
NCT ID: NCT02240238
Last Updated: 2025-01-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
119 participants
INTERVENTIONAL
2014-05-31
2019-05-06
Brief Summary
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In the expansion phase of the study (Part 2), study will evaluate the activity, safety, and tolerability at the RPII dose identified in Part 1 in patients with squamous NSCLC, biliary tract, and bladder cancer.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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NC-6004 and Gemcitabine
NC-6004
NC-6004 - given at escalating doses of 60, 75, 90, 105, 120, 135, 150, 165, or 180 mg/m2 according to observations of dose-limiting toxicity.
Gemcitabine
Gemcitabine 1250 mg/m2 will be administered as a 30 minute intravenous infusion on Day 1 after the completion of the NC 6004 infusion and on Day 8 of each cycle.
Interventions
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NC-6004
NC-6004 - given at escalating doses of 60, 75, 90, 105, 120, 135, 150, 165, or 180 mg/m2 according to observations of dose-limiting toxicity.
Gemcitabine
Gemcitabine 1250 mg/m2 will be administered as a 30 minute intravenous infusion on Day 1 after the completion of the NC 6004 infusion and on Day 8 of each cycle.
Eligibility Criteria
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Inclusion Criteria
* (Part 2 only) Cohort 1: Have histologically or cytologically confirmed diagnosis of Stage IV squamous NSCLC and have not received prior chemotherapy or immunotherapy for metastatic disease and are not known to be PD-L1 positive (known high PD-L1 expression defined as Tumor Proportion Score \[TPS\] greater than or equal to 50%). Patients with known sensitizing mutation in the epidermal growth factor receptor (EGFR) gene or anaplastic lymphoma kinase (ALK) fusion oncogene must have received at least 1 and up to 2 targeted therapies prior to enrollment.
* (Part 2 only) Cohort 2: Have histologically or cytologically confirmed diagnosis of nonresectable, recurrent, or metastatic biliary tract carcinoma (intrahepatic or extrahepatic cholangiocarcinoma, gallbladder cancer, or ampullary carcinoma) and have not received prior systemic anticancer therapy for advanced or metastatic disease.
* (Part 2 only) Cohort 3: Have histologically or cytologically confirmed diagnosis of metastatic or locally advanced TCC of the urinary tract (bladder, urethra, ureter, renal pelvis) (T3b-T4 N0 M0, Tany N1-N3 M0, or Tany Nany M1) and are not candidates for surgery.
* Have measurable disease per RECIST version 1.1.
* Have an ECOG PS of 0 to 1, with the exception of patients in Part 2 (Cohort 3, unfit bladder cancer patients) who may have an ECOG PS of 2
* Adequate bone marrow reserve, liver and renal function
* Have a negative pregnancy test result at Screening for females of childbearing potential
* Male patients must agree to use a condom during treatment and for 90 days after dosing and must agree not to donate sperm for 90 days after dosing
* Women of childbearing potential are willing to agree to use 1 of the study defined effective methods of birth control from the time of study entry to 6 months after the last day of treatment
* Reasonably recovered from preceding major surgery as judged by the investigator or no major surgery within 4 weeks prior to the start of Day 1 treatment
Exclusion Criteria
* Have received prior cisplatin and gemcitabine concomitantly within the last 6 months or are refractory to cisplatin and gemcitabine.
* Unresolved toxicity from prior radiation, chemotherapy, or other targeted treatment, including investigational treatment
* Have evidence suggesting pulmonary fibrosis or interstitial pneumonia.
* Have a history of thrombocytopenia with complications
* Have known hypersensitivity to platinum compounds or gemcitabine.
* Have uncontrolled diabetes or have hypertension requiring more than 3 medications for control of hypertension.
* Have pre-existing alcoholic liver injury or significant liver disease.
* Pregnant or breast feeding
18 Years
ALL
No
Sponsors
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NanoCarrier Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Joao da Silva, MD
Role: PRINCIPAL_INVESTIGATOR
Locations
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California Cancer Associates for Research and Excellence
Encinitas, California, United States
UC San Diego Moores Cancer Center
La Jolla, California, United States
Pacific Hematology Oncology Associates
San Francisco, California, United States
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States
Tufts Medical Center
Boston, Massachusetts, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
University Hospitals Case Medical Center
Cleveland, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
Multiprofile Hospital for Active Treatment Serdika EOOD
Sofia, Sofia-Grad, Bulgaria
Complex Oncology Center - Shumen EOOD
Shumen, , Bulgaria
Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST
Meldola, , Italy
ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda Ca' Granda
Milan, , Italy
Wojewodzki Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie
Krakow, , Poland
Med-Polonia Sp. z o.o.
Poznan, , Poland
Fundeni Clinical Institute
Bucharest, , Romania
Coltea Clinical Hospital
Bucharest, , Romania
Prof Dr I Chiricuta Institute of Oncology
Cluj-Napoca, , Romania
Oncology Center Sfantul Nectarie
Craiova, , Romania
Euroclinic Oncology Center SRL
Iași, , Romania
Institutul Regional de Oncologie Iasi
Iași, , Romania
Countries
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References
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Subbiah V, Grilley-Olson JE, Combest AJ, Sharma N, Tran RH, Bobe I, Osada A, Takahashi K, Balkissoon J, Camp A, Masada A, Reitsma DJ, Bazhenova LA. Phase Ib/II Trial of NC-6004 (Nanoparticle Cisplatin) Plus Gemcitabine in Patients with Advanced Solid Tumors. Clin Cancer Res. 2018 Jan 1;24(1):43-51. doi: 10.1158/1078-0432.CCR-17-1114. Epub 2017 Oct 13.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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NC-6004-004A
Identifier Type: -
Identifier Source: org_study_id
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