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BRIEF TITLE: Trial of NC-6004 (Nanoparticle Cisplatin) Plus Gemcitabine in Patients With Advanced Solid Tumors or Non-Small Cell Lung, Biliary Tract, and Bladder Cancer

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


  • Org Study ID: NC-6004-004A
  • Secondary ID:
  • NCT ID: NCT02240238
  • NCT Alias:
  • Sponsor: NanoCarrier Co., Ltd. - Industry
  • Source: 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.

Overal Status Start Date Phase Study Type
Recruiting May 2014 Phase 1/Phase 2 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Determine the RPII dose of NC-6004 in combination with gemcitabine

Primary Outcome 1 - Time Frame: 1 year

Primary Outcome 2 - Measure: Activity of NC-6004 measured by progression-free survival (PFS)

Primary Outcome 2 - Time Frame: 1 year

Condition:

  • Solid Tumors

Eligibility

Criteria:
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
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Lawrence Frankel, MD

Role: Principal Investigator

Affiliation:

Overall Contact

Name: Holly Lee, GCTM

Phone: +1 612 581 2655

Email: holly.lee@ppdi.com

Locations

Facility Status Contact
California Cancer Associates for Research and Excellence
Encinitas, California 92024
United States
Recruiting
Fresno cCare
Fresno, California 93720
United States
Recruiting
UC San Diego Moores Cancer Center
La Jolla, California 92037
United States
Recruiting
Pacific Hematology Oncology Associates
San Francisco, California 94115
United States
Recruiting
Northwestern University Feinberg School of Medicine
Chicago, Illinois 60611
United States
Not yet recruiting
Tufts Medical Center
Boston, Massachusetts 02111
United States
Recruiting
Billings Clinic
Billings, Montana 59101
United States
Recruiting
Alegent Health
Omaha, Nebraska 68124
United States
Not yet recruiting
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina 27599
United States
Recruiting
University Hospitals Case Medical Center
Cleveland, Ohio 44121
United States
Recruiting
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
United States
Recruiting
University of Texas Southwestern Medical Center
Dallas, Texas 75390
United States
Not yet recruiting
MD Anderson Cancer Center
Houston, Texas 77030
United States
Recruiting
Intermountain Precision Genomics
Murray, Utah 84107
United States
Recruiting
Intermountain Medical Group
Saint George, Utah 84770
United States
Recruiting
Multiprofile Hospital for Active Treatment Serdika EOOD
Sofia, Sofia-Grad 1632
Bulgaria
Recruiting
Complex Oncology Center - Shumen EOOD
Shumen, 9700
Bulgaria
Recruiting
Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST
Meldola, 47014
Italy
Not yet recruiting
ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda Ca' Granda
Milano, 20162
Italy
Not yet recruiting
Wojewodzki Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie
Krakow, 31826
Poland
Not yet recruiting
Med-Polonia Sp. z o.o.
Poznan, 60693
Poland
Not yet recruiting
Fundeni Clinical Institute
Bucharest, 22328
Romania
Not yet recruiting
Coltea Clinical Hospital
Bucharest, 30171
Romania
Not yet recruiting
Prof Dr I Chiricuta Institute of Oncology
Cluj-Napoca, 400015
Romania
Recruiting
Oncology Center Sfantul Nectarie
Craiova, 200347
Romania
Not yet recruiting
Euroclinic Oncology Center SRL
Iasi, 700106
Romania
Not yet recruiting
Institutul Regional de Oncologie Iasi
Iasi, 700483
Romania
Not yet recruiting