Trial · NCT02240238
Combination Therapy With NC-6004 and Gemcitabine in Advanced Solid Tumors or Non-Small Cell Lung, Biliary and Bladder Cancer
NCT02240238, Phase 1, Phase 2, Completed, NanoCarrier Co., Ltd.; results first posted 2025-01-22
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Combination Therapy With NC-6004 and Gemcitabine in Advanced Solid Tumors or Non-Small Cell Lung, Biliary and Bladder Cancer. Trials, record NCT02240238. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02240238
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Combination Therapy With NC-6004 and Gemcitabine in Advanced Solid Tumors or Non-Small Cell Lung, Biliary and Bladder Cancer
- NCT number
- NCT02240238
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 119 participants, actual
- Lead sponsor
- NanoCarrier Co., Ltd.
- Conditions
- Solid Tumors
- Interventions
- NC-6004, Gemcitabine
- First posted
- 2014-09-15
- Last updated
- 2025-01-22
- Results first posted
- 2025-01-22
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Determine the RPII Dose of NC-6004 in Combination With Gemcitabine | 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 |
| Primary | Activity of NC-6004 Measured by Progression-free Survival (PFS) | 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. |
| Secondary | ORR | Up to 40 weeks | To evaluate ORR, DCR (DCR = complete response \[CR\] + partial response \[PR\] + stable disease \[SD\]), DOR, PFS, and OS |
| Secondary | DCR | Up to 40 weeks | To evaluate ORR, DCR (DCR = complete response \[CR\] + partial response \[PR\] + stable disease \[SD\]), DOR, PFS, and OS |
| Secondary | DOR | every 6 weeks tumor assessments for response and disease progression after treatment discontinuation and telephone calls for survival every 12 weeks until disease progression. | To evaluate ORR, DCR (DCR = complete response \[CR\] + partial response \[PR\] + stable disease \[SD\]), DOR, PFS, and OS |
| Secondary | OS | every 6 weeks tumor assessments for response and disease progression after treatment discontinuation and telephone calls for survival every 12 weeks until disease progression. | To evaluate ORR, DCR (DCR = complete response \[CR\] + partial response \[PR\] + stable disease \[SD\]), DOR, PFS, and OS |
| Secondary | EORTC QLQ-C30 | 1 year | 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. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Determine the RPII Dose of NC-6004 in Combination With Gemcitabine | 1 year | Number of participants with at lease one DLT | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Activity of NC-6004 Measured by Progression-free Survival (PFS) | 1 year | days | MEDIAN | |
| SECONDARY | ORR | Up to 40 weeks | This outcome measure was conducted for Phase 2 Arms only as per the Statistical Analysis Plan. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | DCR | Up to 40 weeks | This outcome measure was conducted for Phase 2 Arms only as per the Statistical Analysis Plan. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | DOR | every 6 weeks tumor assessments for response and disease progression after treatment discontinuation and telephone calls for survival every 12 weeks until disease progression. | This outcome measure was conducted for Phase 2 Arms only as per the Statistical Analysis Plan. | days | MEDIAN |
| SECONDARY | OS | every 6 weeks tumor assessments for response and disease progression after treatment discontinuation and telephone calls for survival every 12 weeks until disease progression. | This outcome measure was conducted for Phase 2 Arms only as per the Statistical Analysis Plan. | days | MEDIAN |
| SECONDARY | EORTC QLQ-C30 | 1 year | This outcome measure was conducted for Phase 2 Arms only as per the Statistical Analysis Plan. | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group63
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Determine the RPII Dose of NC-6004 in Combination With Gemcitabine | Phase 1 NC-6004 60 mg/m^2 | 0 | Participants | ||
| Determine the RPII Dose of NC-6004 in Combination With Gemcitabine | Phase 1 NC-6004 75 mg/m^2 | 0 | Participants | ||
| Determine the RPII Dose of NC-6004 in Combination With Gemcitabine | Phase 1 NC-6004 90 mg/m^2 | 0 | Participants | ||
| Determine the RPII Dose of NC-6004 in Combination With Gemcitabine | Phase 1 NC-6004 105 mg/m^2 | 0 | Participants | ||
| Determine the RPII Dose of NC-6004 in Combination With Gemcitabine | Phase 1 NC-6004 120 mg/m^2 | 0 | Participants | ||
| Determine the RPII Dose of NC-6004 in Combination With Gemcitabine | Phase 1 NC-6004 135 mg/m^2 | 0 | Participants | ||
| Determine the RPII Dose of NC-6004 in Combination With Gemcitabine | Phase 1 NC-6004 150 mg/m^2 | 4 | Participants | ||
| Determine the RPII Dose of NC-6004 in Combination With Gemcitabine | Phase 1 NC-6004 165 mg/m^2 | 1 | Participants | ||
| Determine the RPII Dose of NC-6004 in Combination With Gemcitabine | Phase 1 NC-6004 180 mg/m^2 | 1 | Participants | ||
| Activity of NC-6004 Measured by Progression-free Survival (PFS) | Phase 2 Cohort 1 (NSCLC) | 116.0 | 95% Confidence Interval 84.0 to 182.0 | days |
1 to 10 of 63Source ClinicalTrials.gov
See all 63 results by groupParticipant flow72
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Phase 1 | STARTED | Phase 1 NC-6004 60 mg/m^2 | 1 | |
| Phase 1 | STARTED | Phase 1 NC-6004 75 mg/m^2 | 1 | |
| Phase 1 | STARTED | Phase 1 NC-6004 90 mg/m^2 | 1 | |
| Phase 1 | STARTED | Phase 1 NC-6004 105 mg/m^2 | 1 | |
| Phase 1 | STARTED | Phase 1 NC-6004 120 mg/m^2 | 1 | |
| Phase 1 | STARTED | Phase 1 NC-6004 135 mg/m^2 | 9 | |
| Phase 1 | STARTED | Phase 1 NC-6004 150 mg/m^2 | 6 | |
| Phase 1 | STARTED | Phase 1 NC-6004 165 mg/m^2 | 1 | |
| Phase 1 | STARTED | Phase 1 NC-6004 180 mg/m^2 | 1 | |
| Phase 1 | STARTED | Phase 2 Cohort 1 (NSCLC) | 0 |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 participant flowAdverse events1,440
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Activated partial thromboplastin time prolonged | Investigations | Phase 1 NC-6004 60 mg/m^2 | 0 | 1 | |
| other | Activated partial thromboplastin time prolonged | Investigations | Phase 1 NC-6004 75 mg/m^2 | 0 | 1 | |
| other | Activated partial thromboplastin time prolonged | Investigations | Phase 1 NC-6004 90 mg/m^2 | 0 | 1 | |
| other | Activated partial thromboplastin time prolonged | Investigations | Phase 1 NC-6004 105 mg/m^2 | 0 | 1 | |
| other | Activated partial thromboplastin time prolonged | Investigations | Phase 1 NC-6004 120 mg/m^2 | 0 | 1 | |
| other | Activated partial thromboplastin time prolonged | Investigations | Phase 1 NC-6004 135 mg/m^2 | 1 | 9 | |
| other | Activated partial thromboplastin time prolonged | Investigations | Phase 1 NC-6004 150 mg/m^2 | 0 | 6 | |
| other | Activated partial thromboplastin time prolonged | Investigations | Phase 1 NC-6004 165 mg/m^2 | 0 | 1 | |
| other | Activated partial thromboplastin time prolonged | Investigations | Phase 1 NC-6004 180 mg/m^2 | 0 | 1 | |
| other | Activated partial thromboplastin time prolonged | Investigations | Phase 2 Cohort 1 (NSCLC) | 0 | 34 |
1 to 10 of 1,440Source ClinicalTrials.gov
See all 1,440 adverse eventsAdverse event totals36
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase 1 NC-6004 60 mg/m^2 | 0 | 1 |
| Total, all-cause mortality | Phase 1 NC-6004 75 mg/m^2 | 0 | 1 |
| Total, all-cause mortality | Phase 1 NC-6004 90 mg/m^2 | 0 | 1 |
| Total, all-cause mortality | Phase 1 NC-6004 105 mg/m^2 | 0 | 1 |
| Total, all-cause mortality | Phase 1 NC-6004 120 mg/m^2 | 0 | 1 |
| Total, all-cause mortality | Phase 1 NC-6004 135 mg/m^2 | 1 | 9 |
| Total, all-cause mortality | Phase 1 NC-6004 150 mg/m^2 | 0 | 6 |
| Total, all-cause mortality | Phase 1 NC-6004 165 mg/m^2 | 0 | 1 |
| Total, all-cause mortality | Phase 1 NC-6004 180 mg/m^2 | 0 | 1 |
| Total, all-cause mortality | Phase 2 Cohort 1 (NSCLC) | 21 | 34 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 29030354 | BACKGROUND |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02240238
GET https://conductscience.org/api/trials/v1/NCT02240238/results?page=2