Clinical Trials /

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

NCT02240238

Description:

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.

Related Conditions:
  • Ampulla of Vater Carcinoma
  • Bladder Urothelial Carcinoma
  • Cholangiocarcinoma
  • Distal Bile Duct Carcinoma
  • Gallbladder Carcinoma
  • Infiltrating Renal Pelvis and Ureter Urothelial Carcinoma
  • Intrahepatic Cholangiocarcinoma
  • Malignant Solid Tumor
  • Renal Pelvis Urothelial Carcinoma
  • Squamous Cell Lung Carcinoma
  • Ureter Urothelial Carcinoma
  • Urethral Urothelial Carcinoma
  • Urothelial Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: NC-6004-004A
  • NCT ID: NCT02240238

Conditions

  • Solid Tumors

Interventions

DrugSynonymsArms
NC-6004NC-6004 and Gemcitabine
GemcitabineNC-6004 and Gemcitabine

Purpose

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.

Detailed Description

Trial Arms

NameTypeDescriptionInterventions
NC-6004 and GemcitabineExperimental
  • NC-6004
  • Gemcitabine

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

Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Determine the RPII dose of NC-6004 in combination with gemcitabine
Time Frame:1 year
Safety Issue:
Description: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

Secondary Outcome Measures

Measure: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.
Safety Issue:
Description:To evaluate ORR, DCR (DCR = complete response [CR] + partial response [PR] + stable disease [SD]), DOR, PFS, and OS
Measure:Therapy-related AEs
Time Frame:1 year
Safety Issue:
Description:Incidence and severity of therapy-related AEs
Measure:Quality of life
Time Frame:1 year
Safety Issue:
Description:To evaluate QoL using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Measure:Safety and tolerability as measured by severity of AEs and laboratory abnormalities
Time Frame:1 year
Safety Issue:
Description:The safety endpoints for this study are the incidence and severity of AEs and laboratoryabnormalities, 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

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:NanoCarrier Co., Ltd.

Trial Keywords

    Last Updated

    March 29, 2017