Solid TumorPhase 1/2NCT03168061
Dose-Escalation and Expansion Trial of NC-6300 in Patients With Advanced Solid Tumors or Soft Tissue Sarcoma
A Phase 1/2 study testing NC 6300 in people with Solid Tumor and Soft Tissue Sarcoma, run by NanoCarrier Co., Ltd. at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Solid Tumor, Soft Tissue Sarcoma, Metastatic Sarcoma
- What is being tested?
- NC 6300
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 7 sitesUnited States
- Study dates
- 30 Jun 2017to Jul 2020
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (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:
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites, 3 recruiting
- Recruiting
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Juneko Grilley-Olson
- Completed
City of Hope National Medical Center
Duarte, California, 91010
- Recruiting
Duke Cancer Institute
Durham, North Carolina, 27710
Richard Riedel
- Completed
Comprehensive Cancer Centers of Nevada - USOR
Las Vegas, Nevada, 89014
- Completed
University of California Los Angeles
Santa Monica, California, 90095
- Recruiting
Sarcoma Oncology Research Center, LLC.
Santa Monica, California, 90403
Sant Chawla
- Completed
Montefiore Medical Center
The Bronx, New York, 10461-2374
About this study
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
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.
Read the 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.
- Conditions
- Solid Tumor, Soft Tissue Sarcoma, Metastatic Sarcoma, Sarcoma
- Being tested
- NC 6300
- Keywords
- advanced solid tumor, unresectable soft tissue sarcoma
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NC 6300Drug
Part 1: NC-6300 at escalating doses starting at a fixed dose Part 2: NC-6300 at the RPII dose
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: NC 6300 |
What is being measured
The primary outcome is the main question the study is designed to answer.
MTD dose of NC-6300
Measured: up to 7 cycles (21 days/cycle)
RPII dose of NC-6300
Measured: up to 7 cycles (21 days/cycle)
Secondary outcomes (2)
Safety as measured by incidence and severity of TEAEs and laboratory anomalies
To evaluate the overall safety and tolerability of NC-6300 when administered as a single agent
Measured: through study completion, average 1 year
Change in quality of life as measured by EORTC QLQ-C30
To evaluate the change in health-related quality of life following NC-6300 administration
Measured: through study completion, average 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2017
- Study start30 Jun 2017
- Primary completionJul 2020 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NanoCarrier Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Atsushi Osada, Study director, NanoCarrier Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03168061
- Sponsor's protocol ID
- NC-6300-001
- Status last verified
- Feb 2020
- First submitted
- 3 Apr 2017
- Last updated
- 28 Feb 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 35920783
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03168061
- Acronym / sponsor ID
- NC-6300-001
- Conditions
- Solid Tumor, Soft Tissue Sarcoma, Metastatic Sarcoma, Sarcoma
- Keywords
- advanced solid tumor, unresectable soft tissue sarcoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- NanoCarrier Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Jun 2017 (actual)
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 30 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NC-6300 | Experimental | Drug: NC 6300In 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- (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.
- Have measurable disease per RECIST v.1.1.
- Have an ECOG performance status of 0 to 1.
- Have adequate bone marrow reserve defined as:
- Have adequate liver function defined as:
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NC 6300Part 1: NC-6300 at escalating doses starting at a fixed dose Part 2: NC-6300 at the RPII dose | Drug | NC-6300 |
Primary outcome
MTD dose of NC-6300
Time frame: up to 7 cycles (21 days/cycle)
RPII dose of NC-6300
Time frame: up to 7 cycles (21 days/cycle)
2 secondary outcomes
Safety as measured by incidence and severity of TEAEs and laboratory anomalies
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2020.
- Derived from this study: PubMed 35920783Riedel 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Atsushi Osada study director
NanoCarrier Co., Ltd.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing NC 6300 in people with Solid Tumor and Soft Tissue Sarcoma, run by NanoCarrier Co., Ltd. at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amanda Knight (+1 919 443 3476, aknight@cato.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MTD dose of NC-6300 (time frame: up to 7 cycles (21 days/cycle)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03168061, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2020.