Combination Therapy With NC-6004 and Gemcitabine in Advanced Solid Tumors or Non-Small Cell Lung, Biliary and Bladder Cancer

Completed · Phase 1/Phase 2

Conditions studied: Solid Tumors

In brief

In the dose escalation phase (Part 1), this study will determine the dose-limiting toxicities (DLTs), the maximum tolerated dose (MTD) and recommended Phase 2 (RPII) dose of NC 6004 in combination with gemcitabine. 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.

Key facts

Study ID

NCT02240238

Run by

NanoCarrier Co., Ltd.

People needed

119

Starts

2014-05-01

Expected to finish

2019-05-06

Last updated by the study team

2025-01-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• (Part 1 only) Have a histologically or cytologically confirmed diagnosis of advanced solid tumor that has relapsed or is refractory to standard curative or palliative therapy or has a contraindication to standard therapy.
• (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

You may not qualify if…

• Have received prior platinum therapy in the past 3 months (Part 1) or 6 months in the adjuvant or neoadjuvant setting (Part 2).
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.