Solid TumorsPhase 1/2NCT02240238

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

A Phase 1/2 study testing NC-6004 and Gemcitabine in people with Solid Tumors, run by NanoCarrier Co., Ltd. at 22 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Solid Tumors
What is being tested?: NC-6004 and Gemcitabine
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 119 participants
Where: 22 sitesin 5 countries
Study dates: May 2014to 6 May 2019
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

(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

Show all 11Show fewer

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

Who cannot join

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.

Show all 9Show fewer

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

Trial locations and contacts

22 sites in 5 countries.

Country

City, postcode or hospital

22 sites in 5 countries

United States10 sites

Tufts Medical Center
Boston, Massachusetts, 02111
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
University Hospitals Case Medical Center
Cleveland, Ohio, 44121
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
California Cancer Associates for Research and Excellence
Encinitas, California, 92024
MD Anderson Cancer Center
Houston, Texas, 77030
UC San Diego Moores Cancer Center
La Jolla, California, 92037
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Pacific Hematology Oncology Associates
San Francisco, California, 94115

Other trials in United States

Romania6 sites

Fundeni Clinical Institute
Bucharest, 22328
Coltea Clinical Hospital
Bucharest, 30171
Prof Dr I Chiricuta Institute of Oncology
Cluj-Napoca, 400015
Oncology Center Sfantul Nectarie
Craiova, 200347
Euroclinic Oncology Center SRL
Iași, 700106
Institutul Regional de Oncologie Iasi
Iași, 700483

Other trials in Romania

Bulgaria2 sites

Complex Oncology Center - Shumen EOOD
Shumen, 9700
Multiprofile Hospital for Active Treatment Serdika EOOD
Sofia, Sofia-Grad, 1632

Other trials in Bulgaria

Italy2 sites

Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST
Meldola, 47014
ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda Ca' Granda
Milan, 20162

Other trials in Italy

Poland2 sites

Wojewodzki Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie
Krakow, 31826
Med-Polonia Sp. z o.o.
Poznan, 60693

Other trials in Poland

About this study

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

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.

Conditions: Solid Tumors
Being tested: NC-6004, Gemcitabine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NC-6004Drug
NC-6004 - given at escalating doses of 60, 75, 90, 105, 120, 135, 150, 165, or 180 mg/m2 according to observations of dose-limiting toxicity.
GemcitabineDrug
Gemcitabine 1250 mg/m2 will be administered as a 30 minute intravenous infusion on Day 1 after the completion of the NC 6004 infusion and on Day 8 of each cycle.

Study groups in NCT02240238
Study group	Role	What they receive
NC-6004 and Gemcitabine	Experimental	Not described Receives: Drug: NC-6004; Drug: Gemcitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

Determine the RPII Dose of NC-6004 in Combination With Gemcitabine
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
Measured: 1 year
Activity of NC-6004 Measured by Progression-free Survival (PFS)
In the expansion phase of the study (Part 2), to evaluate the activity of NC-6004 in combination with gemcitabine in patients with first-line Stage IV squamous NSCLC, first-line advanced or metastatic biliary tract cancer, and first-line metastatic or locally advanced bladder cancer compared with historical control as measured by local investigator/radiologist-assessed progression-free survival (PFS), according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Measured: 1 year

Secondary outcomes (5)

ORR
To evaluate ORR, DCR (DCR = complete response [CR] + partial response [PR] + stable disease [SD]), DOR, PFS, and OS
Measured: Up to 40 weeks
DCR
To evaluate ORR, DCR (DCR = complete response [CR] + partial response [PR] + stable disease [SD]), DOR, PFS, and OS
Measured: Up to 40 weeks
DOR
To evaluate ORR, DCR (DCR = complete response [CR] + partial response [PR] + stable disease [SD]), DOR, PFS, and OS
Measured: every 6 weeks tumor assessments for response and disease progression after treatment discontinuation and telephone calls for survival every 12 weeks until disease progression.
OS
To evaluate ORR, DCR (DCR = complete response [CR] + partial response [PR] + stable disease [SD]), DOR, PFS, and OS
Measured: every 6 weeks tumor assessments for response and disease progression after treatment discontinuation and telephone calls for survival every 12 weeks until disease progression.
EORTC QLQ-C30
The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) has the 5 functional scales (physical, role, emotional, cognitive, social), and 9 symptom scales (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). All of the scales and single item measures range in score from 0 to 100. A positive value of change from baseline means a better outcome in functional scales and a worse outcome in symptom scales.
Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 20146 May 2019

First posted15 Sep 2014 (estimated)
Study startMay 2014
Primary completion6 May 2019
Study completion6 May 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Solid TumorsStudies 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: 119 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02240238
Sponsor's protocol ID: NC-6004-004A
Status last verified: Jan 2025
First submitted: 19 Aug 2014
Last updated: 22 Jan 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Subbiah V, Grilley-Olson JE, Combest AJ, Sharma N, Tran RH, Bobe I, Osada A, Takahashi K, Balkissoon J, Camp A, Masada A, Reitsma DJ, Bazhenova LA. Phase Ib/II Trial of NC-6004 (Nanoparticle Cisplatin) Plus Gemcitabine in Patients with Advanced Solid Tumors. Clin Cancer Res. 2018 Jan 1;24(1):43-51. doi: 10.1158/1078-0432.CCR-17-1114. Epub 2017 Oct 13.
PubMed 29030354

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08032562 in People With Advanced or Metastatic Solid Tumors
Advanced Breast Cancer, Metastatic Breast Cancer (HR+/ HER2-)
Enrolling by invitationObservational study
Collection of Tissue Specimens From Patients With Solid Tumors or Blood Disorders and Their HLA-Compatible Family Members
Neoplasms, Hematologic Neoplasms
Not yet recruitingPhase 2
Psilocybin With Psychotherapy for Improving Chronic Pain in Cancer Patients Requiring Opioids
Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
RecruitingPhase 3
REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis
Cancer-Associated Thrombosis (CAT)

All Solid Tumors trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Jan 2025. 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-6004 (Nanoparticle Cisplatin) Plus Gemcitabine in Patients With Advanced Solid Tumors or Non-Small Cell Lung, Biliary Tract, and Bladder Cancer
ClinicalTrials.gov ID: NCT02240238
Acronym / sponsor ID: NC-6004-004A
Conditions: Solid Tumors
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 119 participants (actual)
Lead sponsor: NanoCarrier Co., Ltd.Industry (pharma, biotech, devices)
Study start: May 2014 (actual)
Primary completion: 6 May 2019 (actual)
Study completion: 6 May 2019 (actual)
First posted: 15 Sep 2014 (estimated)
Results: Posted 22 Jan 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
NC-6004 and Gemcitabine	Experimental	Drug: NC-6004, Drug: Gemcitabine

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

(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.

Key exclusion criteria (9 listed)

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

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-6004NC-6004 - given at escalating doses of 60, 75, 90, 105, 120, 135, 150, 165, or 180 mg/m2 according to observations of dose-limiting toxicity.	Drug	NC-6004 and Gemcitabine
GemcitabineGemcitabine 1250 mg/m2 will be administered as a 30 minute intravenous infusion on Day 1 after the completion of the NC 6004 infusion and on Day 8 of each cycle.	Drug	NC-6004 and Gemcitabine

Primary outcome

Determine the RPII Dose of NC-6004 in Combination With Gemcitabine
Time frame: 1 year
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
Activity of NC-6004 Measured by Progression-free Survival (PFS)
Time frame: 1 year
In the expansion phase of the study (Part 2), to evaluate the activity of NC-6004 in combination with gemcitabine in patients with first-line Stage IV squamous NSCLC, first-line advanced or metastatic biliary tract cancer, and first-line metastatic or locally advanced bladder cancer compared with historical control as measured by local investigator/radiologist-assessed progression-free survival (PFS), according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

5 secondary outcomes

ORR
Time frame: Up to 40 weeks
DCR
Time frame: Up to 40 weeks
DOR
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.
OS
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.
EORTC QLQ-C30
Time frame: 1 year

Results and safety

Results posted to the registry on 22 Jan 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Phase 1 NC-6004 60 mg/m^2	1	1
Phase 1 NC-6004 75 mg/m^2	1	1
Phase 1 NC-6004 90 mg/m^2	1	1
Phase 1 NC-6004 105 mg/m^2	1	1
Phase 1 NC-6004 120 mg/m^2	1	1
Phase 1 NC-6004 135 mg/m^2	9	3
Phase 1 NC-6004 150 mg/m^2	6	3
Phase 1 NC-6004 165 mg/m^2	1	0
Phase 1 NC-6004 180 mg/m^2	1	1
Phase 2 Cohort 1 (NSCLC)	0	0
Phase 2 Cohort 2 (Biliary Tract Cancer)	0	0
Phase 2 Cohort 3 (Bladder Cancer)	0	0

Primary outcome: Determine the RPII Dose of NC-6004 in Combination With Gemcitabine

Time frame: 1 year. Count of participants. Unit: Participants

Measure	Phase 1 NC-6004 60 mg/m^2 n = 1	Phase 1 NC-6004 75 mg/m^2 n = 1	Phase 1 NC-6004 90 mg/m^2 n = 1	Phase 1 NC-6004 105 mg/m^2 n = 1	Phase 1 NC-6004 120 mg/m^2 n = 1	Phase 1 NC-6004 135 mg/m^2 n = 9	Phase 1 NC-6004 150 mg/m^2 n = 6	Phase 1 NC-6004 165 mg/m^2 n = 1	Phase 1 NC-6004 180 mg/m^2 n = 1
Value	0	0	0	0	0	0	4	1	1

Population analysed: Number of participants with at lease one DLT

Primary outcome: Activity of NC-6004 Measured by Progression-free Survival (PFS)

Time frame: 1 year. Median (95% Confidence Interval). Unit: days

Measure	Phase 2 Cohort 1 (NSCLC) n = 34	Phase 2 Cohort 2 (Biliary Tract Cancer) n = 50	Phase 2 Cohort 3 (Bladder Cancer) n = 13
Value	116.0 (84.0 to 182.0)	128.0 (86.0 to 181.0)	204.0 (130.0 to 233.0)

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 year. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Phase 1 NC-6004 60 mg/m^2	0 of 1 (0%)	1 of 1 (100%)	0 of 1
Phase 1 NC-6004 75 mg/m^2	0 of 1 (0%)	1 of 1 (100%)	0 of 1
Phase 1 NC-6004 90 mg/m^2	0 of 1 (0%)	1 of 1 (100%)	0 of 1
Phase 1 NC-6004 105 mg/m^2	0 of 1 (0%)	1 of 1 (100%)	0 of 1
Phase 1 NC-6004 120 mg/m^2	0 of 1 (0%)	1 of 1 (100%)	0 of 1
Phase 1 NC-6004 135 mg/m^2	4 of 9 (44.4%)	9 of 9 (100%)	1 of 9
Phase 1 NC-6004 150 mg/m^2	3 of 6 (50%)	6 of 6 (100%)	0 of 6
Phase 1 NC-6004 165 mg/m^2	1 of 1 (100%)	1 of 1 (100%)	0 of 1
Phase 1 NC-6004 180 mg/m^2	1 of 1 (100%)	1 of 1 (100%)	0 of 1
Phase 2 Cohort 1 (NSCLC)	13 of 34 (38.2%)	34 of 34 (100%)	21 of 34
Phase 2 Cohort 2 (Biliary Tract Cancer)	17 of 50 (34%)	50 of 50 (100%)	30 of 50
Phase 2 Cohort 3 (Bladder Cancer)	4 of 13 (30.8%)	13 of 13 (100%)	9 of 13

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 29030354Subbiah V, Grilley-Olson JE, Combest AJ, Sharma N, Tran RH, Bobe I, Osada A, Takahashi K, Balkissoon J, Camp A, Masada A, Reitsma DJ, Bazhenova LA. Phase Ib/II Trial of NC-6004 (Nanoparticle Cisplatin) Plus Gemcitabine in Patients with Advanced Solid Tumors. Clin Cancer Res. 2018 Jan 1;24(1):43-51. doi: 10.1158/1078-0432.CCR-17-1114. Epub 2017 Oct 13.

Related trials for Solid Tumors

RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08032562 in People With Advanced or Metastatic Solid Tumors
Advanced Breast Cancer, Metastatic Breast Cancer (HR+/ HER2-)
Enrolling by invitationObservational study
Collection of Tissue Specimens From Patients With Solid Tumors or Blood Disorders and Their HLA-Compatible Family Members
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Not yet recruitingPhase 2
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RecruitingPhase 3
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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.

Joao da Silva, MD principal investigator

22 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing NC-6004 and Gemcitabine in people with Solid Tumors, run by NanoCarrier Co., Ltd. at 22 sites in 5 countries.

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 11 inclusion and 9 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: finished, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in United States, Romania, Bulgaria, Italy, Poland. 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?

Yes. Results are posted in the registry (first posted 22 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determine the RPII Dose of NC-6004 in Combination With Gemcitabine (time frame: 1 year). 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 NCT02240238, 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 22 Jan 2025.