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

NCT03168061 | Unknown Phase 1 FDA Drug

• 1 other identifier: NC-6300-001
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 7

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.

Conditions

Solid Tumor; Soft Tissue Sarcoma; Metastatic Sarcoma; Sarcoma

Keywords

advanced solid tumor; unresectable soft tissue sarcoma

Outcome Measures

Primary Outcomes (2)

• MTD dose of NC-6300

  up to 7 cycles (21 days/cycle)

• RPII dose of NC-6300

  up to 7 cycles (21 days/cycle)

Secondary Outcomes (2)

• Safety as measured by incidence and severity of TEAEs and laboratory anomalies

  through study completion, average 1 year

• Change in quality of life as measured by EORTC QLQ-C30

  through study completion, average 1 year

Other Outcomes (9)

• Ceoi

  through study completion, average 1 year

• Cmax

  through study completion, average 1 year

• Tmax

  through study completion, average 1 year

Study Arms (1)

NC-6300

EXPERIMENTAL

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

Interventions

NC 6300 DRUG

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

NC-6300

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NanoCarrier Co., Ltd.: lead

Study Sites (7)

City of Hope National Medical Center

Duarte, California, 91010, United States

COMPLETED

University of California Los Angeles

Santa Monica, California, 90095, United States

COMPLETED

Sarcoma Oncology Research Center, LLC.

Santa Monica, California, 90403, United States

RECRUITING

Comprehensive Cancer Centers of Nevada - USOR

Las Vegas, Nevada, 89014, United States

COMPLETED

Montefiore Medical Center

The Bronx, New York, 10461-2374, United States

COMPLETED

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Duke Cancer Institute

Durham, North Carolina, 27710, United States

RECRUITING

Related Publications (1)

• Riedel RF, Chua V, Moradkhani A, Krkyan N, Ahari A, Osada A, Chawla SP. Results of NC-6300 (Nanoparticle Epirubicin) in an Expansion Cohort of Patients with Angiosarcoma. Oncologist. 2022 Oct 1;27(10):809-e765. doi: 10.1093/oncolo/oyac155.

  PMID: 35920783 DERIVED

MeSH Terms

Conditions

Sarcoma

Interventions

NC 6300

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Atsushi Osada

  NanoCarrier Co., Ltd.

  STUDY DIRECTOR

Central Study Contacts

Amanda Knight

CONTACT

+1 919 443 3476; aknight@cato.com

Arnavaz Eduljee

CONTACT

+1 919 443 3372; AEduljee@cato.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: open label
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2017
• First Posted: May 30, 2017
• Study Start: June 30, 2017
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: February 28, 2020

Record last verified: 2020-02

Locations

US (7)