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Dose-Escalation and Expansion Trial of NC-6300 in Patients With Advanced Solid Tumors or Soft Tissue Sarcoma

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ClinicalTrials.gov Identifier: NCT03168061
Recruitment Status : Recruiting
First Posted : May 30, 2017
Last Update Posted : September 19, 2018
Sponsor:
Information provided by (Responsible Party):
NanoCarrier Co., Ltd.

Brief Summary:
The goal of this study is to find the highest tolerated dose of NC-6300 that can be given to patients with advanced solid tumors or soft tissue sarcoma. The safety and tolerability of the drug will also be studied.

Condition or disease Intervention/treatment Phase
Solid Tumor Soft Tissue Sarcoma Metastatic Sarcoma Sarcoma Drug: NC 6300 Phase 1 Phase 2

Detailed Description:
The first part of the study will determine the maximum tolerated dose (MTD), dose-limiting toxicities (DLTs), and the recommended Phase 2 (RPII) dose of NC-6300. The second part of the study will assess the activity and tolerability of NC-6300 in patients with soft tissue sarcoma.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 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-6300 (Nanoparticle Epirubicin) in Patients With Advanced Solid Tumors or Advanced, Metastatic, or Unresectable Soft Tissue Sarcoma
Actual Study Start Date : June 30, 2017
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: NC-6300

In Part 1, patients will receive an intravenous infusion of NC-6300 at escalating doses starting at a fixed dose on Day 1 of a 21-day cycle. After enrollment of the initial patient, the first patient in each cohort will not be enrolled until all patients at the immediately lower cohort have completed at least 1 full 21-day cycle. In Part 1, patients will continue to receive treatment until they experience disease progression, experience unacceptable toxicity, or withdraw voluntarily.

Part 2 will begin after the RPII dose of NC-6300 is identified. All patients in Part 2 will receive NC-6300 at the RPII dose.

Drug: NC 6300
Part 1: NC-6300 at escalating doses starting at a fixed dose Part 2: NC-6300 at the RPII dose




Primary Outcome Measures :
  1. MTD dose of NC-6300 [ Time Frame: up to 7 cycles (21 days/cycle) ]
  2. RPII dose of NC-6300 [ Time Frame: up to 7 cycles (21 days/cycle) ]

Secondary Outcome Measures :
  1. Safety as measured by incidence and severity of TEAEs and laboratory anomalies [ Time Frame: through study completion, average 1 year ]
    To evaluate the overall safety and tolerability of NC-6300 when administered as a single agent

  2. Change in quality of life as measured by EORTC QLQ-C30 [ Time Frame: through study completion, average 1 year ]
    To evaluate the change in health-related quality of life following NC-6300 administration


Other Outcome Measures:
  1. Ceoi [ Time Frame: through study completion, average 1 year ]
    To characterize the pharmacokinetics of NC-6300.

  2. Cmax [ Time Frame: through study completion, average 1 year ]
    To characterize the pharmacokinetics of NC-6300.

  3. Tmax [ Time Frame: through study completion, average 1 year ]
    To characterize the pharmacokinetics of NC-6300.

  4. AUC [ Time Frame: through study completion, average 1 year ]
    To characterize the pharmacokinetics of NC-6300.

  5. t1/2 [ Time Frame: through study completion, average 1 year ]
    To characterize the pharmacokinetics of NC-6300.

  6. Kel [ Time Frame: through study completion, average 1 year ]
    To characterize the pharmacokinetics of NC-6300.

  7. CL [ Time Frame: through study completion, average 1 year ]
    To characterize the pharmacokinetics of NC-6300.

  8. Vd [ Time Frame: through study completion, average 1 year ]
    To characterize the pharmacokinetics of NC-6300.

  9. Ctrough [ Time Frame: through study completion, average 1 year ]
    To characterize the pharmacokinetics of NC-6300.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • (Part 1 only) Have a histologically/cytologically confirmed diagnosis of advanced solid tumor, including sarcoma that is refractory to standard therapy. (Part 2 only) Have a histologically confirmed diagnosis of advanced, unresectable, or metastatic soft tissue sarcoma not amenable to curative treatment with surgery or radiotherapy.

    • Cohort 1: First-line soft tissue sarcoma of intermediate or high grade. Adjuvant or neoadjuvant chemotherapy allowed if no tumor recurrence for at least 12 months since the last measurement, beginning or end of last chemotherapy.
    • Cohort 2: Soft tissue sarcoma of intermediate or high grade with evidence of disease progression by either CT or MRI scan, or clinical judgment on or after the last cancer therapy within 6 months prior to the start of study treatment. Relapsed or refractory (lack of response) to ≥1 course of systemic therapy regimen(s), excluding adjuvant or neoadjuvant chemotherapy, and is incurable by either surgery or radiation. Patients who have previously received anthracyclines are eligible if cumulative exposure is <375 mg/m2 for doxorubicin and liposomal doxorubicin or <675 mg/m2 for EPI.
  • Have measurable disease per RECIST v.1.1.
  • Have an ECOG performance status of 0 to 1.
  • Have adequate bone marrow reserve defined as:

    • Absolute neutrophil count of at least 1.5 × 109/L,
    • Platelet count of at least 100 × 109/L, and
    • Hemoglobin level of at least 10 g/dL (transfusion is allowed to achieve hemoglobin level of at least 10 g/dL).
  • Have adequate liver function defined as:

    • Total serum bilirubin <1.5 × ULN and
    • ALT and AST <2.5 × ULN or, in patients with documented hepatic metastasis, ≤5.0 × ULN.
  • Have adequate heart function defined as:

    • LVEF of at least 50%
    • Baseline QTc ≤470 msec and no previous history of QT prolongation while taking other medications.
  • Have adequate renal function defined as a creatinine clearance ≥50 mL/minute (calculated according to the formula of Cockcroft and Gault 1976) or serum creatinine <1.5 mg/dL.
  • Have reasonably recovered from preceding major surgery as judged by the investigator or have had no major surgery within 4 weeks prior to Day 1 treatment.
  • Have stopped previous anticancer therapy for at least 2 weeks or 5 half-lives (whichever is longer) if the immediate prior regimen included only chemotherapy; or 4 weeks or 5 half-lives (whichever is longer) from any therapy with therapeutic biologics and from any type of investigational therapy.
  • Women of childbearing potential are will to agree to use 1 of the study defined effective methods of birth control from the time of study entry to 60 days after the final study drug administration
  • Women of childbearing potential must have a negative urine pregnancy test at screening, and
  • Male patients must use highly effective contraception methods consisting of 2 forms of birth control (at least 1 of which must be a barrier method) starting at screening and continuing throughout the study period and for 60 days after the final study drug administration.

Exclusion Criteria:

  • Prior exposure to >375 mg/m2 of doxorubicin or liposomal doxorubicin or ≥675 mg/m2 of EPI.
  • Palliative surgery and/or radiation treatment within 30 days prior to date of screening visit.
  • (Part 2 only) Current evidence/diagnosis of alveolar soft part sarcoma, extraskeletal myxoid chondrosarcoma, rhabdomyosarcoma, osteosarcoma, gastrointestinal stromal tumor, dermatofibrosarcoma (unless transformed to fibrosarcoma), Ewing's sarcoma, Kaposi's sarcoma, mixed mesodermal tumor, or clear cell sarcomas.
  • Evidence of central nervous system metastasis and have not received prior definitive therapy for their lesions.
  • Are unable to receive anthracycline therapy due to previous toxicity.
  • Have unresolved toxicity from prior radiation, chemotherapy, or other targeted treatment, including investigational treatment, with the exception of alopecia and ≤Grade 1 peripheral neuropathy according to the NCI CTCAE v4.03. Clinical judgment by the investigator is allowed to determine if Grade 1 fatigue at screening is residual toxicity from prior treatment or is a symptom of the patient's general condition or disease. The investigator and Medical Monitor will discuss the eligibility of patients with baseline toxicity.
  • Have a history of thrombocytopenia with complications including hemorrhage or bleeding of ≥Grade 2 per NCI CTCAE v4.03 that required medical intervention or have any hemolytic condition or coagulation disorder that would make participation unsafe in the opinion of the investigator.
  • Have known hypersensitivity to anthracycline compounds or any excipient in NC-6300.
  • Have uncontrolled diabetes or have hypertension requiring more than 3 medications for control of hypertension.
  • Have an active, clinically significant serious infection requiring intravenous treatment with antibiotics, antivirals, or antifungals.
  • Have signs or symptoms of organ failure, major chronic illnesses other than cancer, or any concomitant medical or social condition that, in the opinion of the investigator, make it undesirable for the patient to participate in the study or that could jeopardize compliance with the protocol.
  • Have experienced any of the following within the 6-month period prior to screening: angina pectoris, coronary artery disease or cerebrovascular accident, transient ischemic attack, cardiac failure with known ejection fraction less than 40%, or severe uncontrolled ventricular arrhythmia.

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 ClinicalTrials.gov identifier (NCT number): NCT03168061


Contacts
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Contact: Amy Callahan +1 919 443 3356 ACallahan@cato.com
Contact: Arnavaz Eduljee +1 919 443 3372 AEduljee@cato.com

Locations
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United States, California
City of Hope National Medical Center Recruiting
Duarte, California, United States, 91010
Contact: Warren Chow         
University of California Los Angeles Recruiting
Santa Monica, California, United States, 90095
Contact: Arun Singh         
Sarcoma Oncology Research Center, LLC. Recruiting
Santa Monica, California, United States, 90403
Contact: Sant Chawla         
United States, Indiana
Parkview Research Center Recruiting
Fort Wayne, Indiana, United States, 46845
Contact: Alexander Starodub         
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Brian Van Tine         
United States, Nevada
Comprehensive Cancer Centers of Nevada - USOR Recruiting
Las Vegas, Nevada, United States, 89014
Contact: Fadi Braiteh         
United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10461-2374
Contact: Sanjay Goel         
United States, North Carolina
University of North Carolina at Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Juneko Grilley-Olson         
Duke Cancer Institute Recruiting
Durham, North Carolina, United States, 27710
Contact: Richard Riedel         
Sponsors and Collaborators
NanoCarrier Co., Ltd.
Investigators
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Study Director: Atsushi Osada NanoCarrier Co., Ltd.

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Responsible Party: NanoCarrier Co., Ltd.
ClinicalTrials.gov Identifier: NCT03168061     History of Changes
Other Study ID Numbers: NC-6300-001
First Posted: May 30, 2017    Key Record Dates
Last Update Posted: September 19, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by NanoCarrier Co., Ltd.:
advanced solid tumor
unresectable soft tissue sarcoma
Additional relevant MeSH terms:
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Sarcoma
Neoplasms
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Epirubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action