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

Sponsor
NanoCarrier Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT02240238
Collaborator
(none)
209
Enrollment
22
Locations
1
Arm
60.2
Actual Duration (Months)
9.5
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
209 participants
Allocation:
N/A
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 1, 2014
Actual Primary Completion Date :
May 6, 2019
Actual Study Completion Date :
May 6, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Determine the RPII dose of NC-6004 in combination with gemcitabine [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) [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 [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 [1 year]

    Incidence and severity of therapy-related AEs

  3. EORTC QLQ-C30 [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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 California Cancer Associates for Research and Excellence Encinitas California United States 92024
2 UC San Diego Moores Cancer Center La Jolla California United States 92037
3 Pacific Hematology Oncology Associates San Francisco California United States 94115
4 Northwestern University Feinberg School of Medicine Chicago Illinois United States 60611
5 Tufts Medical Center Boston Massachusetts United States 02111
6 University of North Carolina at Chapel Hill Chapel Hill North Carolina United States 27599
7 University Hospitals Case Medical Center Cleveland Ohio United States 44121
8 University of Oklahoma Health Sciences Center Oklahoma City Oklahoma United States 73104
9 University of Texas Southwestern Medical Center Dallas Texas United States 75390
10 MD Anderson Cancer Center Houston Texas United States 77030
11 Multiprofile Hospital for Active Treatment Serdika EOOD Sofia Sofia-Grad Bulgaria 1632
12 Complex Oncology Center - Shumen EOOD Shumen Bulgaria 9700
13 Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST Meldola Italy 47014
14 ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda Ca' Granda Milano Italy 20162
15 Wojewodzki Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie Krakow Poland 31826
16 Med-Polonia Sp. z o.o. Poznan Poland 60693
17 Fundeni Clinical Institute Bucharest Romania 22328
18 Coltea Clinical Hospital Bucharest Romania 30171
19 Prof Dr I Chiricuta Institute of Oncology Cluj-Napoca Romania 400015
20 Oncology Center Sfantul Nectarie Craiova Romania 200347
21 Euroclinic Oncology Center SRL Iasi Romania 700106
22 Institutul Regional de Oncologie Iasi Iasi Romania 700483

Sponsors and Collaborators

  • NanoCarrier Co., Ltd.

Investigators

  • Principal Investigator: Joao da Silva, MD,

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
NanoCarrier Co., Ltd.
ClinicalTrials.gov Identifier:
NCT02240238
Other Study ID Numbers:
  • NC-6004-004A
First Posted:
Sep 15, 2014
Last Update Posted:
Feb 28, 2020
Last Verified:
Feb 1, 2020
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Gemcitabine

Study Results

No Results Posted as of Feb 28, 2020