- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03168061
Dose-Escalation and Expansion Trial of NC-6300 in Patients With Advanced Solid Tumors or Soft Tissue Sarcoma
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
California
-
Duarte, California, United States, 91010
- Completed
- City of Hope National Medical Center
-
Santa Monica, California, United States, 90095
- Completed
- University of California Los Angeles
-
Santa Monica, California, United States, 90403
- Recruiting
- Sarcoma Oncology Research Center, LLC.
-
-
Nevada
-
Las Vegas, Nevada, United States, 89014
- Completed
- Comprehensive Cancer Centers of Nevada - USOR
-
-
New York
-
Bronx, New York, United States, 10461-2374
- Completed
- Montefiore Medical Center
-
-
North Carolina
-
Chapel Hill, North Carolina, United States, 27599
- Recruiting
- University of North Carolina at Chapel Hill
-
Contact:
- Juneko Grilley-Olson
-
Durham, North Carolina, United States, 27710
- Recruiting
- Duke Cancer Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / 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. |
Part 1: NC-6300 at escalating doses starting at a fixed dose Part 2: NC-6300 at the RPII dose
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
MTD dose of NC-6300
Time Frame: up to 7 cycles (21 days/cycle)
|
up to 7 cycles (21 days/cycle)
|
RPII dose of NC-6300
Time Frame: up to 7 cycles (21 days/cycle)
|
up to 7 cycles (21 days/cycle)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
through study completion, average 1 year
|
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
|
through study completion, average 1 year
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ceoi
Time Frame: through study completion, average 1 year
|
To characterize the pharmacokinetics of NC-6300.
|
through study completion, average 1 year
|
Cmax
Time Frame: through study completion, average 1 year
|
To characterize the pharmacokinetics of NC-6300.
|
through study completion, average 1 year
|
Tmax
Time Frame: through study completion, average 1 year
|
To characterize the pharmacokinetics of NC-6300.
|
through study completion, average 1 year
|
AUC
Time Frame: through study completion, average 1 year
|
To characterize the pharmacokinetics of NC-6300.
|
through study completion, average 1 year
|
t1/2
Time Frame: through study completion, average 1 year
|
To characterize the pharmacokinetics of NC-6300.
|
through study completion, average 1 year
|
Kel
Time Frame: through study completion, average 1 year
|
To characterize the pharmacokinetics of NC-6300.
|
through study completion, average 1 year
|
CL
Time Frame: through study completion, average 1 year
|
To characterize the pharmacokinetics of NC-6300.
|
through study completion, average 1 year
|
Vd
Time Frame: through study completion, average 1 year
|
To characterize the pharmacokinetics of NC-6300.
|
through study completion, average 1 year
|
Ctrough
Time Frame: through study completion, average 1 year
|
To characterize the pharmacokinetics of NC-6300.
|
through study completion, average 1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Atsushi Osada, NanoCarrier Co., Ltd.
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NC-6300-001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Sarcoma
-
Albert Einstein College of MedicineNational Cancer Institute (NCI)TerminatedUterine Corpus Leiomyosarcoma | Stage IIA Uterine Sarcoma | Stage IIB Uterine Sarcoma | Stage IIIA Uterine Sarcoma | Stage IIIB Uterine Sarcoma | Stage IIIC Uterine Sarcoma | Stage IVA Uterine Sarcoma | Stage IVB Uterine Sarcoma | Stage IA Uterine Sarcoma | Stage IB Uterine Sarcoma | Stage IC Uterine SarcomaUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)CompletedBone Sarcoma | Retroperitoneal Sarcoma | Adult Soft Tissue SarcomaUnited States
-
Mohammed M MilhemGenentech, Inc.CompletedSarcoma | Soft Tissue Sarcoma | Metastatic Sarcoma | Locally Advanced Sarcoma | Unresectable SarcomaUnited States
-
National Cancer Institute (NCI)RecruitingMetastatic Alveolar Soft Part Sarcoma | Unresectable Alveolar Soft Part Sarcoma | Advanced Soft Tissue Sarcoma | Advanced Alveolar Soft Part SarcomaUnited States
-
National Cancer Institute (NCI)RecruitingMetastatic Leiomyosarcoma | Unresectable Leiomyosarcoma | Metastatic Sarcoma | Unresectable Soft Tissue Sarcoma | Metastatic Soft Tissue Sarcoma | Unresectable SarcomaUnited States
-
National Cancer Institute (NCI)CompletedRhabdomyosarcoma | Synovial Sarcoma | Ewing's Sarcoma | MPNST | High-risk SarcomaUnited States
-
Epizyme, Inc.RecruitingAdvanced Soft-tissue Sarcoma | Advanced Epithelioid SarcomaUnited States, Taiwan, Canada, United Kingdom
-
Brown UniversityActuate Therapeutics Inc.WithdrawnSoft Tissue Sarcoma | Osteosarcoma | Ewing Sarcoma of Bone | Leiomyosarcoma | High Grade Sarcoma | Liposarcoma | Rhabdomyosarcoma | Angiosarcoma | Bone Sarcoma | Synovial Sarcoma | Undifferentiated Pleomorphic Sarcoma | Myxofibrosarcoma | Spindle Cell SarcomaUnited States
-
David DickensWithdrawnSoft Tissue Sarcoma | Bone Sarcoma | Unresectable Soft Tissue Sarcoma | Metastatic Soft-tissue Sarcoma | Metastatic Bone Sarcoma | Unresectable Bone SarcomaUnited States
-
OHSU Knight Cancer InstituteNational Cancer Institute (NCI)WithdrawnStage III Adult Soft Tissue Sarcoma | Stage IV Adult Soft Tissue Sarcoma | Stage II Adult Soft Tissue Sarcoma | Stage IIA Adult Soft Tissue Sarcoma | Stage IIB Adult Soft Tissue Sarcoma | Stage IIC Adult Soft Tissue Sarcoma
Clinical Trials on NC 6300
-
University of HelsinkiFinnish Cultural Foundation; University of Oulu; Finnish Work Environment Fund; Juho Vainio Foundation and other collaboratorsUnknownLow Back Pain | Low Back Pain, RecurrentFinland
-
Fundación EPICCompletedCardiovascular Diseases | Arterial DiseaseSpain
-
Fundación EPICCompletedIschemic Heart Disease | Coronary Artery Disease (CAD)Spain
-
Deutsches Herzzentrum MuenchenSIS Medical AGCompletedCalcified Coronary Artery Disease (Grade 3)Germany, Switzerland
-
Nanjing First Hospital, Nanjing Medical UniversityCompleted
-
University Hospital, Clermont-FerrandJacques Lacarin Hospital Center; CH MontluçonUnknown
-
Natural CyclesCompleted
-
Puerta de Hierro University HospitalCompletedPost-Traumatic Syringomyelia
-
Seoul National University Bundang HospitalBayerCompletedTraumaKorea, Republic of
-
Columbia UniversityRecruitingChild Development | Mother-Infant Interaction | Relation, Parent-ChildUnited States