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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02240238
Recruitment Status : Recruiting
First Posted : September 15, 2014
Last Update Posted : November 5, 2018
Information provided by (Responsible Party):
NanoCarrier Co., Ltd.

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Solid Tumors Drug: NC-6004 Drug: Gemcitabine Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 209 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1b/2 Dose Escalation and Expansion Trial of NC-6004 (Nanoparticle Cisplatin) Plus Gemcitabine in Patients With Advanced Solid Tumors or Non-Small Cell Lung, Biliary Tract, and Bladder Cancer
Actual Study Start Date : May 2014
Estimated Primary Completion Date : November 30, 2019
Estimated Study Completion Date : November 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Arm Intervention/treatment
Experimental: NC-6004 and Gemcitabine Drug: 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.

Drug: 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.

Primary Outcome Measures :
  1. Determine the RPII dose of NC-6004 in combination with gemcitabine [ Time Frame: 1 year ]
    In the dose-escalation phase of the study (Part 1), to determine the dose-limiting toxicities (DLTs), MTD, and RPII dose of NC-6004 in combination with gemcitabine

  2. Activity of NC-6004 measured by progression-free survival (PFS) [ Time Frame: 1 year ]
    In the expansion phase of the study (Part 2), to evaluate the activity of NC-6004 in combination with gemcitabine in patients with first-line Stage IV squamous NSCLC, first-line advanced or metastatic biliary tract cancer, and first-line metastatic or locally advanced bladder cancer compared with historical control as measured by local investigator/radiologist-assessed progression-free survival (PFS), according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

Secondary Outcome Measures :
  1. Overall response rate [ Time Frame: every 6 weeks tumor assessments for response and disease progression after treatment discontinuation and telephone calls for survival every 12 weeks until disease progression. ]
    To evaluate ORR, DCR (DCR = complete response [CR] + partial response [PR] + stable disease [SD]), DOR, PFS, and OS

  2. Therapy-related AEs [ Time Frame: 1 year ]
    Incidence and severity of therapy-related AEs

  3. EORTC QLQ-C30 [ Time Frame: 1 year ]
    To evaluate QoL using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)

  4. Safety and tolerability as measured by severity of AEs and laboratory abnormalities [ Time Frame: 1 year ]
    The safety endpoints for this study are the incidence and severity of AEs and laboratory abnormalities, according to the NCI CTCAE version 4.03, the occurrence of SAEs and treatment discontinuations due to AEs, and nausea severity and vomiting incidence obtained from the patient diary

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • (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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02240238

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Contact: Holly Lee, GCTM +1 612 581 2655
Contact: Atsushi Osada, Study Director +818037213752

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United States, California
California Cancer Associates for Research and Excellence Recruiting
Encinitas, California, United States, 92024
UC San Diego Moores Cancer Center Recruiting
La Jolla, California, United States, 92037
Pacific Hematology Oncology Associates Recruiting
San Francisco, California, United States, 94115
United States, Illinois
Northwestern University Feinberg School of Medicine Recruiting
Chicago, Illinois, United States, 60611
United States, Massachusetts
Tufts Medical Center Recruiting
Boston, Massachusetts, United States, 02111
United States, North Carolina
University of North Carolina at Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
University Hospitals Case Medical Center Recruiting
Cleveland, Ohio, United States, 44121
United States, Oklahoma
University of Oklahoma Health Sciences Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
United States, Texas
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Multiprofile Hospital for Active Treatment Serdika EOOD Recruiting
Sofia, Sofia-Grad, Bulgaria, 1632
Complex Oncology Center - Shumen EOOD Recruiting
Shumen, Bulgaria, 9700
Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST Recruiting
Meldola, Italy, 47014
ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda Ca' Granda Recruiting
Milano, Italy, 20162
Wojewodzki Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie Recruiting
Krakow, Poland, 31826
Med-Polonia Sp. z o.o. Recruiting
Poznan, Poland, 60693
Fundeni Clinical Institute Recruiting
Bucharest, Romania, 22328
Coltea Clinical Hospital Recruiting
Bucharest, Romania, 30171
Prof Dr I Chiricuta Institute of Oncology Recruiting
Cluj-Napoca, Romania, 400015
Oncology Center Sfantul Nectarie Recruiting
Craiova, Romania, 200347
Euroclinic Oncology Center SRL Recruiting
Iasi, Romania, 700106
Institutul Regional de Oncologie Iasi Recruiting
Iasi, Romania, 700483
Sponsors and Collaborators
NanoCarrier Co., Ltd.
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Principal Investigator: Joao da Silva, MD

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Responsible Party: NanoCarrier Co., Ltd. Identifier: NCT02240238     History of Changes
Other Study ID Numbers: NC-6004-004A
First Posted: September 15, 2014    Key Record Dates
Last Update Posted: November 5, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs