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

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

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02240238
Enrollment
119
Registered
2014-09-15
Start date
2014-05-31
Completion date
2019-05-06
Last updated
2025-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solid Tumors

Brief 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. 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.

Interventions

DRUGGemcitabine

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.

DRUGNC-6004

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.

Sponsors

NanoCarrier Co., Ltd.
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Masking description

Open Label

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* (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 * 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

Exclusion criteria

* 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. * 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

Design outcomes

Primary

MeasureTime frameDescription
Determine the RPII Dose of NC-6004 in Combination With Gemcitabine1 yearIn 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)1 yearIn 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

MeasureTime frameDescription
DORevery 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
ORRUp to 40 weeksTo evaluate ORR, DCR (DCR = complete response \[CR\] + partial response \[PR\] + stable disease \[SD\]), DOR, PFS, and OS
EORTC QLQ-C301 yearThe 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.
OSevery 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
DCRUp to 40 weeksTo evaluate ORR, DCR (DCR = complete response \[CR\] + partial response \[PR\] + stable disease \[SD\]), DOR, PFS, and OS

Countries

Bulgaria, Italy, Poland, Romania, United States

Participant flow

Participants by arm

ArmCount
Phase 1 NC-6004 60 mg/m^2
Participants received intravenous (IV) infusion of NC-6004 60 mg/m\^2 on Day 1 and gemcitabine 1250 mg/m\^2 on Days 1 and 8 in 3-week treatment cycles until they experienced disease progression.
1
Phase 1 NC-6004 75 mg/m^2
Participants received IV infusion of NC-6004 75 mg/m\^2 on Day 1 and gemcitabine 1250 mg/m\^2 on Days 1 and 8 in 3-week treatment cycles until they experienced disease progression.
1
Phase 1 NC-6004 90 mg/m^2
Participants received IV infusion of NC-6004 90 mg/m\^2 on Day 1 and gemcitabine 1250 mg/m\^2 on Days 1 and 8 in 3-week treatment cycles until they experienced disease progression.
1
Phase 1 NC-6004 105 mg/m^2
Participants received IV infusion of NC-6004 105 mg/m\^2 on Day 1 and gemcitabine 1250 mg/m\^2 on Days 1 and 8 in 3-week treatment cycles until they experienced disease progression.
1
Phase 1 NC-6004 120 mg/m^2
Participants received IV infusion of NC-6004 120 mg/m\^2 on Day 1 and gemcitabine 1250 mg/m\^2 on Days 1 and 8 in 3-week treatment cycles until they experienced disease progression.
1
Phase 1 NC-6004 135 mg/m^2
Participants received IV infusion of NC-6004 135 mg/m\^2 on Day 1 and gemcitabine 1250 mg/m\^2 on Days 1 and 8 in 3-week treatment cycles until they experienced disease progression.
9
Phase 1 NC-6004 150 mg/m^2
Participants received IV infusion of NC-6004 150 mg/m\^2 on Day 1 and gemcitabine 1250 mg/m\^2 on Days 1 and 8 in 3-week treatment cycles until they experienced disease progression.
6
Phase 1 NC-6004 165 mg/m^2
Participants received IV infusion of NC-6004 165 mg/m\^2 on Day 1 and gemcitabine 1250 mg/m\^2 on Days 1 and 8 in 3-week treatment cycles until they experienced disease progression.
1
Phase 1 NC-6004 180 mg/m^2
Participants received IV infusion of NC-6004 180 mg/m\^2 on Day 1 and gemcitabine 1250 mg/m\^2 on Days 1 and 8 in 3-week treatment cycles until they experienced disease progression.
1
Phase 2 Cohort 1 (NSCLC)
Participants with non-small-cell lung cancer (NSCLC) received IV infusion of NC-6004 135 mg/m\^2 on Day 1 and gemcitabine 1250 mg/m\^2 on Days 1 and 8 in 3-week treatment cycles for up to 6 cycles.
33
Phase 2 Cohort 2 (Biliary Tract Cancer)
Participants with biliary tract cancer received IV infusion of NC-6004 135 mg/m\^2 on Day 1 and gemcitabine 1250 mg/m\^2 on Days 1 and 8 in 3-week treatment cycles for up to 8 cycles.
49
Phase 2 Cohort 3 (Bladder Cancer)
Participants with bladder cancer received IV infusion of NC-6004 135 mg/m\^2 on Day 1 and gemcitabine 1250 mg/m\^2 on Days 1 and 8 in 3-week treatment cycles for up to 6 cycles.
12
Total116

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003FG004FG005FG006FG007FG008FG009FG010FG011
Phase 1Adverse Event000000310000
Phase 1Death000001000000
Phase 1Physician Decision000002000000
Phase 1Sponsor termination000001000000
Phase 1Withdrawal by Subject000002000000
Phase 2Adverse Event0000000007142
Phase 2CONTINUE WITH ONLY GEMCITABINE, AS PER PARTICIPANT DECISION000000000010
Phase 2Death000000000321
Phase 2Disease progression0000000005111
Phase 2PARTICIPANT DECIDED TO COME OFF THE STUDY AS STUDY WAS ON HOLD. AND DECIDED TO MOVE TO SOC000000000010
Phase 2PARTICIPANT DECIDED TO TAKE STANDARD OF CARE TREATMENT000000000010
Phase 2PARTICIPANT WAS DECLINING CLINICALLY000000000010
Phase 2PARTICIPANT WAS DISCONTINUED DUE TO THEIR DETERIORATING CONDITION/CLINICAL PROGRESSION000000000100
Phase 2Physician Decision000000000130
Phase 2TREATMENT DELAY >14 DAYS000000000010
Phase 2TREATMENT DELAY GREATER THAN 14 DAYS000000000001
Phase 2TREATMENT NOT COMPLETED, PARTICIPANT MISSED C6D8 DUE TO PERSONAL REASON000000000100
Phase 2Withdrawal by Subject000000000110

Baseline characteristics

CharacteristicPhase 1 NC-6004 60 mg/m^2Phase 1 NC-6004 90 mg/m^2Phase 1 NC-6004 105 mg/m^2Phase 1 NC-6004 120 mg/m^2Phase 1 NC-6004 135 mg/m^2Phase 1 NC-6004 150 mg/m^2Phase 1 NC-6004 165 mg/m^2Phase 1 NC-6004 180 mg/m^2Phase 2 Cohort 1 (NSCLC)Phase 1 NC-6004 75 mg/m^2Phase 2 Cohort 2 (Biliary Tract Cancer)Phase 2 Cohort 3 (Bladder Cancer)Total
Age, Categorical
Phase 1
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Phase 1
>=65 years
0 Participants0 Participants1 Participants0 Participants2 Participants0 Participants0 Participants0 Participants0 Participants1 Participants0 Participants0 Participants4 Participants
Age, Categorical
Phase 1
Between 18 and 65 years
1 Participants1 Participants0 Participants1 Participants7 Participants6 Participants1 Participants1 Participants0 Participants0 Participants0 Participants0 Participants18 Participants
Age, Categorical
Phase 2
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Phase 2
>=65 years
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants11 Participants0 Participants17 Participants6 Participants34 Participants
Age, Categorical
Phase 2
Between 18 and 65 years
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants22 Participants0 Participants32 Participants6 Participants60 Participants
Age, Continuous
Phase 1
54.0 years56.0 years69.0 years37.0 years60.0 years
STANDARD_DEVIATION 7.75
33.7 years
STANDARD_DEVIATION 9.42
62.0 years61.0 years—67.0 years——52.2 years
STANDARD_DEVIATION 14.57
Age, Continuous
Phase 2
————————61.7 years
STANDARD_DEVIATION 9.1
—62.6 years
STANDARD_DEVIATION 8.51
65.2 years
STANDARD_DEVIATION 11.87
62.6 years
STANDARD_DEVIATION 9.04
Ethnicity (NIH/OMB)
Phase 1
Hispanic or Latino
0 Participants0 Participants0 Participants1 Participants1 Participants2 Participants0 Participants0 Participants—0 Participants——4 Participants
Ethnicity (NIH/OMB)
Phase 1
Not Hispanic or Latino
0 Participants0 Participants1 Participants0 Participants8 Participants3 Participants1 Participants1 Participants—1 Participants——15 Participants
Ethnicity (NIH/OMB)
Phase 1
Unknown or Not Reported
1 Participants1 Participants0 Participants0 Participants0 Participants1 Participants0 Participants0 Participants—0 Participants——3 Participants
Ethnicity (NIH/OMB)
Phase 2
Hispanic or Latino
————————0 Participants—2 Participants0 Participants2 Participants
Ethnicity (NIH/OMB)
Phase 2
Not Hispanic or Latino
————————33 Participants—47 Participants12 Participants92 Participants
Ethnicity (NIH/OMB)
Phase 2
Unknown or Not Reported
————————0 Participants—0 Participants0 Participants0 Participants
Height
Phase 1
187.0 cm165.10 cm189.20 cm162.60 cm171.08 cm
STANDARD_DEVIATION 12.473
175.67 cm
STANDARD_DEVIATION 13.803
164.00 cm180.30 cm—181.0 cm——173.73 cm
STANDARD_DEVIATION 12.125
Height
Phase 2
————————170.98 cm
STANDARD_DEVIATION 8.724
—169.23 cm
STANDARD_DEVIATION 8.847
172.02 cm
STANDARD_DEVIATION 4.183
170.14 cm
STANDARD_DEVIATION 8.323
Race (NIH/OMB)
Phase 1
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants—0 Participants——0 Participants
Race (NIH/OMB)
Phase 1
Asian
0 Participants0 Participants0 Participants0 Participants1 Participants0 Participants0 Participants0 Participants—0 Participants——1 Participants
Race (NIH/OMB)
Phase 1
Black or African American
1 Participants0 Participants1 Participants0 Participants1 Participants2 Participants0 Participants0 Participants—0 Participants——5 Participants
Race (NIH/OMB)
Phase 1
More than one race
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants—0 Participants——0 Participants
Race (NIH/OMB)
Phase 1
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants—0 Participants——0 Participants
Race (NIH/OMB)
Phase 1
Unknown or Not Reported
0 Participants0 Participants0 Participants1 Participants0 Participants2 Participants0 Participants0 Participants—0 Participants——3 Participants
Race (NIH/OMB)
Phase 1
White
0 Participants1 Participants0 Participants0 Participants7 Participants2 Participants1 Participants1 Participants—1 Participants——13 Participants
Race (NIH/OMB)
Phase 2
American Indian or Alaska Native
————————0 Participants—0 Participants0 Participants0 Participants
Race (NIH/OMB)
Phase 2
Asian
————————0 Participants—2 Participants0 Participants2 Participants
Race (NIH/OMB)
Phase 2
Black or African American
————————0 Participants—1 Participants1 Participants2 Participants
Race (NIH/OMB)
Phase 2
More than one race
————————0 Participants—0 Participants0 Participants0 Participants
Race (NIH/OMB)
Phase 2
Native Hawaiian or Other Pacific Islander
————————0 Participants—0 Participants0 Participants0 Participants
Race (NIH/OMB)
Phase 2
Unknown or Not Reported
————————0 Participants—2 Participants0 Participants2 Participants
Race (NIH/OMB)
Phase 2
White
————————33 Participants—44 Participants11 Participants88 Participants
Sex: Female, Male
Phase 1
Female
0 Participants1 Participants0 Participants1 Participants5 Participants3 Participants1 Participants0 Participants0 Participants0 Participants0 Participants0 Participants11 Participants
Sex: Female, Male
Phase 1
Male
1 Participants0 Participants1 Participants0 Participants4 Participants3 Participants0 Participants1 Participants0 Participants1 Participants0 Participants0 Participants11 Participants
Sex: Female, Male
Phase 2
Female
————————7 Participants—18 Participants1 Participants26 Participants
Sex: Female, Male
Phase 2
Male
————————26 Participants—31 Participants11 Participants68 Participants
Weight
Phase 1
84.10 kg72.70 kg104.70 kg120.10 kg72.93 kg
STANDARD_DEVIATION 15.336
72.45 kg
STANDARD_DEVIATION 13.307
62.90 kg110.70 kg—84.10 kg——78.65 kg
STANDARD_DEVIATION 18.333
Weight
Phase 2
————————70.47 kg
STANDARD_DEVIATION 17.877
—73.57 kg
STANDARD_DEVIATION 16.527
83.83 kg
STANDARD_DEVIATION 13.355
74.16 kg
STANDARD_DEVIATION 17.214

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
EG006
affected / at risk
EG007
affected / at risk
EG008
affected / at risk
EG009
affected / at risk
EG010
affected / at risk
EG011
affected / at risk
deaths
Total, all-cause mortality
0 / 10 / 10 / 10 / 10 / 11 / 90 / 60 / 10 / 121 / 3430 / 509 / 13
other
Total, other adverse events
1 / 11 / 11 / 11 / 11 / 19 / 96 / 61 / 11 / 134 / 3450 / 5013 / 13
serious
Total, serious adverse events
0 / 10 / 10 / 10 / 10 / 14 / 93 / 61 / 11 / 113 / 3417 / 504 / 13

Outcome results

Primary

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.

Time frame: 1 year

ArmMeasureValue (MEDIAN)
Phase 1 NC-6004 60 mg/m^2Activity of NC-6004 Measured by Progression-free Survival (PFS)116.0 days
Phase 1 NC-6004 75 mg/m^2Activity of NC-6004 Measured by Progression-free Survival (PFS)128.0 days
Phase 1 NC-6004 90 mg/m^2Activity of NC-6004 Measured by Progression-free Survival (PFS)204.0 days
Primary

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

Time frame: 1 year

Population: Number of participants with at lease one DLT

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Phase 1 NC-6004 60 mg/m^2Determine the RPII Dose of NC-6004 in Combination With Gemcitabine0 Participants
Phase 1 NC-6004 75 mg/m^2Determine the RPII Dose of NC-6004 in Combination With Gemcitabine0 Participants
Phase 1 NC-6004 90 mg/m^2Determine the RPII Dose of NC-6004 in Combination With Gemcitabine0 Participants
Phase 1 NC-6004 105 mg/m^2Determine the RPII Dose of NC-6004 in Combination With Gemcitabine0 Participants
Phase 1 NC-6004 120 mg/m^2Determine the RPII Dose of NC-6004 in Combination With Gemcitabine0 Participants
Phase 1 NC-6004 135 mg/m^2Determine the RPII Dose of NC-6004 in Combination With Gemcitabine0 Participants
Phase 1 NC-6004 150 mg/m^2Determine the RPII Dose of NC-6004 in Combination With Gemcitabine4 Participants
Phase 1 NC-6004 165 mg/m^2Determine the RPII Dose of NC-6004 in Combination With Gemcitabine1 Participants
Phase 1 NC-6004 180 mg/m^2Determine the RPII Dose of NC-6004 in Combination With Gemcitabine1 Participants
Secondary

DCR

To evaluate ORR, DCR (DCR = complete response \[CR\] + partial response \[PR\] + stable disease \[SD\]), DOR, PFS, and OS

Time frame: Up to 40 weeks

Population: This outcome measure was conducted for Phase 2 Arms only as per the Statistical Analysis Plan.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Phase 1 NC-6004 60 mg/m^2DCR12 Participants
Phase 1 NC-6004 75 mg/m^2DCR19 Participants
Phase 1 NC-6004 90 mg/m^2DCR7 Participants
Secondary

DOR

To evaluate ORR, DCR (DCR = complete response \[CR\] + partial response \[PR\] + stable disease \[SD\]), DOR, PFS, and 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.

Population: This outcome measure was conducted for Phase 2 Arms only as per the Statistical Analysis Plan.

ArmMeasureValue (MEDIAN)
Phase 1 NC-6004 60 mg/m^2DOR232.0 days
Phase 1 NC-6004 75 mg/m^2DORNA days
Phase 1 NC-6004 90 mg/m^2DOR133.0 days
Secondary

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.

Time frame: 1 year

Population: This outcome measure was conducted for Phase 2 Arms only as per the Statistical Analysis Plan.

ArmMeasureGroupValue (MEAN)Dispersion
Phase 1 NC-6004 60 mg/m^2EORTC QLQ-C30Diarrhoea5.797 score on a scaleStandard Deviation 12.9184
Phase 1 NC-6004 60 mg/m^2EORTC QLQ-C30Dyspnoea4.348 score on a scaleStandard Deviation 23.1472
Phase 1 NC-6004 60 mg/m^2EORTC QLQ-C30Fatigue11.594 score on a scaleStandard Deviation 17.5613
Phase 1 NC-6004 60 mg/m^2EORTC QLQ-C30Emotional Functioning Scale-2.536 score on a scaleStandard Deviation 22.3938
Phase 1 NC-6004 60 mg/m^2EORTC QLQ-C30Pain8.696 score on a scaleStandard Deviation 26.5288
Phase 1 NC-6004 60 mg/m^2EORTC QLQ-C30Nausea/Vomiting10.870 score on a scaleStandard Deviation 13.8614
Phase 1 NC-6004 60 mg/m^2EORTC QLQ-C30Physical Functioning Scale-16.522 score on a scaleStandard Deviation 20.8767
Phase 1 NC-6004 60 mg/m^2EORTC QLQ-C30Role Functioning Scale-10.870 score on a scaleStandard Deviation 27.344
Phase 1 NC-6004 60 mg/m^2EORTC QLQ-C30Appetite Loss15.942 score on a scaleStandard Deviation 29.9319
Phase 1 NC-6004 60 mg/m^2EORTC QLQ-C30Cognitive Functioning Scale-5.797 score on a scaleStandard Deviation 19.2069
Phase 1 NC-6004 60 mg/m^2EORTC QLQ-C30Financial Difficulties10.145 score on a scaleStandard Deviation 21.165
Phase 1 NC-6004 60 mg/m^2EORTC QLQ-C30Insomnia-1.449 score on a scaleStandard Deviation 27.4842
Phase 1 NC-6004 60 mg/m^2EORTC QLQ-C30Social Functioning Scale-7.971 score on a scaleStandard Deviation 32.9024
Phase 1 NC-6004 75 mg/m^2EORTC QLQ-C30Nausea/Vomiting10.417 score on a scaleStandard Deviation 25.2304
Phase 1 NC-6004 75 mg/m^2EORTC QLQ-C30Physical Functioning Scale-14.000 score on a scaleStandard Deviation 18.7835
Phase 1 NC-6004 75 mg/m^2EORTC QLQ-C30Role Functioning Scale-13.750 score on a scaleStandard Deviation 33.7342
Phase 1 NC-6004 75 mg/m^2EORTC QLQ-C30Emotional Functioning Scale-1.667 score on a scaleStandard Deviation 22.8958
Phase 1 NC-6004 75 mg/m^2EORTC QLQ-C30Cognitive Functioning Scale-0.833 score on a scaleStandard Deviation 20.9972
Phase 1 NC-6004 75 mg/m^2EORTC QLQ-C30Social Functioning Scale-13.333 score on a scaleStandard Deviation 30.9397
Phase 1 NC-6004 75 mg/m^2EORTC QLQ-C30Fatigue14.444 score on a scaleStandard Deviation 28.4895
Phase 1 NC-6004 75 mg/m^2EORTC QLQ-C30Pain5.833 score on a scaleStandard Deviation 30.5575
Phase 1 NC-6004 75 mg/m^2EORTC QLQ-C30Dyspnoea6.667 score on a scaleStandard Deviation 28.445
Phase 1 NC-6004 75 mg/m^2EORTC QLQ-C30Insomnia12.500 score on a scaleStandard Deviation 29.8977
Phase 1 NC-6004 75 mg/m^2EORTC QLQ-C30Appetite Loss9.167 score on a scaleStandard Deviation 43.3547
Phase 1 NC-6004 75 mg/m^2EORTC QLQ-C30Diarrhoea0.833 score on a scaleStandard Deviation 14.0967
Phase 1 NC-6004 75 mg/m^2EORTC QLQ-C30Financial Difficulties5.833 score on a scaleStandard Deviation 22.5036
Phase 1 NC-6004 90 mg/m^2EORTC QLQ-C30Dyspnoea0.000 score on a scaleStandard Deviation 28.4268
Phase 1 NC-6004 90 mg/m^2EORTC QLQ-C30Cognitive Functioning Scale2.778 score on a scaleStandard Deviation 24.4467
Phase 1 NC-6004 90 mg/m^2EORTC QLQ-C30Diarrhoea0.000 score on a scaleStandard Deviation 0
Phase 1 NC-6004 90 mg/m^2EORTC QLQ-C30Insomnia11.111 score on a scaleStandard Deviation 25.95
Phase 1 NC-6004 90 mg/m^2EORTC QLQ-C30Emotional Functioning Scale-10.648 score on a scaleStandard Deviation 32.0641
Phase 1 NC-6004 90 mg/m^2EORTC QLQ-C30Physical Functioning Scale-12.222 score on a scaleStandard Deviation 22.3531
Phase 1 NC-6004 90 mg/m^2EORTC QLQ-C30Appetite Loss2.778 score on a scaleStandard Deviation 17.1643
Phase 1 NC-6004 90 mg/m^2EORTC QLQ-C30Nausea/Vomiting-4.167 score on a scaleStandard Deviation 10.3597
Phase 1 NC-6004 90 mg/m^2EORTC QLQ-C30Fatigue13.889 score on a scaleStandard Deviation 28.0792
Phase 1 NC-6004 90 mg/m^2EORTC QLQ-C30Role Functioning Scale-18.056 score on a scaleStandard Deviation 21.8562
Phase 1 NC-6004 90 mg/m^2EORTC QLQ-C30Pain6.944 score on a scaleStandard Deviation 20.6685
Phase 1 NC-6004 90 mg/m^2EORTC QLQ-C30Social Functioning Scale-5.556 score on a scaleStandard Deviation 21.7113
Phase 1 NC-6004 90 mg/m^2EORTC QLQ-C30Financial Difficulties2.778 score on a scaleStandard Deviation 17.1643
Secondary

ORR

To evaluate ORR, DCR (DCR = complete response \[CR\] + partial response \[PR\] + stable disease \[SD\]), DOR, PFS, and OS

Time frame: Up to 40 weeks

Population: This outcome measure was conducted for Phase 2 Arms only as per the Statistical Analysis Plan.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Phase 1 NC-6004 60 mg/m^2ORR4 Participants
Phase 1 NC-6004 75 mg/m^2ORR4 Participants
Phase 1 NC-6004 90 mg/m^2ORR3 Participants
Secondary

OS

To evaluate ORR, DCR (DCR = complete response \[CR\] + partial response \[PR\] + stable disease \[SD\]), DOR, PFS, and 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.

Population: This outcome measure was conducted for Phase 2 Arms only as per the Statistical Analysis Plan.

ArmMeasureValue (MEDIAN)
Phase 1 NC-6004 60 mg/m^2OS275.0 days
Phase 1 NC-6004 75 mg/m^2OS350.0 days
Phase 1 NC-6004 90 mg/m^2OS316.0 days

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026