Lung Cancer, Lung Cancer, Nonsmall Cell, Lung Cancer, Small Cell, Neoplasm of Lung
Conditions
Keywords
paclitaxel
Brief summary
This study evaluates the use of NanoPac injected directly into tumors in the lung of people with lung cancer.
Detailed description
NanoPac is very small (submicron) particles of the chemotherapy drug, paclitaxel, which is administered intravenously in a number of types of cancer. These submicron particles are injected directly into solid tumors to target cancer at the site of disease with less systemic exposure than intravenously administered chemotherapy. In this study, the submicron particle paclitaxel will be injected directly into tumors in the lungs of people with small cell or non-small cell lung cancer. All subjects in this study will receive NanoPac and will be evaluated to see if NanoPac is safe and has an effect on the tumor within the lung.
Interventions
NanoPac is manufactured using a Precipitation with Compressed Antisolvent (PCA) technique that employs supercritical carbon dioxide and acetone to generate paclitaxel nanoparticles within a well-characterized particle-size distribution. Following PCA, NanoPac is filled into a clear 60mL Type 1, USP, clear-glass vial (306 mg/vial) as a powder fill of nanoparticulate paclitaxel, closed with a bromobutyl rubber stopper and aluminum crimp seal, and sterilized by gamma irradiation. Prior to administration at the hospital/clinic, NanoPac will be reconstituted with 1% Polysorbate 80, NF in 0.9% Sodium Chloride for Injection, USP, to form a suspension. The suspension will be further diluted with 0.9% Sodium Chloride for Injection, USP to achieve the final clinical formulation.
Sponsors
US Biotest, Inc.
NanOlogy, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Signed informed consent; * Age ≥18 years and able to tolerate the EBUS-TBNI procedure; * Histologically/cytologically confirmed lung cancer. Eligible subjects may include, for example: primary or recurrent non-resectable disease, locally advanced stages II and III with nodal disease, stage IV advanced disease; * At least one lesion documented via imaging (within 4 weeks of Screening) which can be accessed using EBUS-TBNI; * Subject is not a candidate for surgery; * Has received or plans to receive SOC chemotherapy; adequate hematologic recovery must be confirmed according to the institution's SOC; * Performance Status (ECOG) 0-2 at study entry; * Life expectancy of at least 6 months; * Adequate marrow, liver, and renal function at study entry; * ANC ≥ 1.5 x 109/L; * Hemoglobin ≥ 9.0 grams/dL; * Platelets ≥ 75 x 109/L; * Total bilirubin ≤ 1.5x institutional ULN; * AST/ ALT ≤ 2.5x institutional ULN; * Creatinine ≤ 1.5x institutional ULN; * Appropriate steps taken to minimize or avoid the potential for pregnancy for subjects of child-bearing potential.\*
Exclusion criteria
* Significant cardiac disease (Class III or IV per New York Heart Association guidelines); * Active bacterial, viral, or fungal infections (including active AIDS, hepatitis B or hepatitis C); * Symptomatic central nervous system (CNS) metastasis which are neurologically unstable, or CNS disease requiring increase in steroid dose (treated metastatic disease and stable steroid use are not excluded) * Known hypersensitivity to study agent; * Pregnant or breastfeeding women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events | Day 1 to Week 24 (6 Months) | AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Concentration of Paclitaxel in the Systemic Circulation Post-injection | Day 1, Weeks 1, 2, 4, 5, 6, 8, 9, 10, 12, 18, and 24 | To characterize the pharmacokinetics of intratumoral NanoPac, plasma samples were taken on days of NanoPac injection prior to injection and at 1, 2, and 4 hours after NanoPac injection, as well as at all other study visits up through Week 24. Plasma paclitaxel concentrations are reported in pg/mL. |
| Progression Free Survival (PFS) | Weeks 24, 38, and 52 | Progression free survival (PFS) as assessed using RECIST v1.1 |
| Overall Survival | Weeks 24, 38, and 52 | Overall survival (OS) as determined by survival time following first NanoPac injection |
| Change in Tumor Dimensions (Longest Diameter) | Weeks 12, 24, 38, and 52 | Change in longest dimension (cm) as determined by CT imaging compared to baseline (Screening) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| NanoPac 15 mg/mL Intratumoral injection of NanoPac 15 mg/mL at a volume of up to 20% of the total calculated tumor and lymph node volume (not to exceed 40 mL) on up to three occasions 4 weeks apart. | 18 |
| Total | 18 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 10 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Physician Decision | 2 |
Baseline characteristics
| Characteristic | NanoPac 15 mg/mL |
|---|---|
| Age, Continuous Age | 68.4 years STANDARD_DEVIATION 9.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 17 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 17 Participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 14 Participants |
| Type of Lung Cancer Adenocarcinoma | 8 Participants |
| Type of Lung Cancer Squamous cell carcinoma | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 3 | 3 / 5 | 6 / 10 |
| other Total, other adverse events | 3 / 3 | 5 / 5 | 10 / 10 |
| serious Total, serious adverse events | 2 / 3 | 3 / 5 | 7 / 10 |
Outcome results
Primary
Number of Participants With Treatment Emergent Adverse Events
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Time frame: Day 1 to Week 24 (6 Months)
Population: All subjects enrolled provided data for this outcome measure.~Of the 18 subjects enrolled, one subject in the NanoPac 15 mg/ml - One Injection arm was determined to have non-malignant disease after pathology review following initial injection with NanoPac, and this subject is therefore not included in efficacy assessments but was included in the outcome measure of number of participants with treatment emergent adverse events.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NanoPac 15 mg/mL | Number of Participants With Treatment Emergent Adverse Events | 18 Participants |
Secondary
Change in Tumor Dimensions (Longest Diameter)
Change in longest dimension (cm) as determined by CT imaging compared to baseline (Screening)
Time frame: Weeks 12, 24, 38, and 52
Population: Of the 18 subjects enrolled, one subject in the NanoPac 15 mg/ml - One Injection arm was determined to have non-malignant disease after pathology review following initial injection with NanoPac, and this subject is therefore not included in efficacy assessments, i.e. change in tumor dimensions (longest diameter). The remaining two subjects in the NanoPac 15 mg/ml - One Injection arm discontinued from the study prior to Week 12.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NanoPac 15 mg/mL - Two Injections | Change in Tumor Dimensions (Longest Diameter) | Week 12 - Change from Baseline | 2.06 cm | Standard Deviation 2.913 |
| NanoPac 15 mg/mL - Two Injections | Change in Tumor Dimensions (Longest Diameter) | Week 24 - Change from Baseline | 1.26 cm | Standard Deviation 1.216 |
| NanoPac 15 mg/mL - Two Injections | Change in Tumor Dimensions (Longest Diameter) | Week 38 - Change from Baseline | 1.0 cm | — |
| NanoPac 15 mg/mL - Two Injections | Change in Tumor Dimensions (Longest Diameter) | Week 52 - Change from Baseline | 1.62 cm | — |
| NanoPac 15 mg/mL - Three Injections | Change in Tumor Dimensions (Longest Diameter) | Week 52 - Change from Baseline | -0.91 cm | Standard Deviation 0.753 |
| NanoPac 15 mg/mL - Three Injections | Change in Tumor Dimensions (Longest Diameter) | Week 12 - Change from Baseline | -0.23 cm | Standard Deviation 0.907 |
| NanoPac 15 mg/mL - Three Injections | Change in Tumor Dimensions (Longest Diameter) | Week 38 - Change from Baseline | -0.85 cm | Standard Deviation 0.635 |
| NanoPac 15 mg/mL - Three Injections | Change in Tumor Dimensions (Longest Diameter) | Week 24 - Change from Baseline | -0.78 cm | Standard Deviation 0.678 |
Secondary
Concentration of Paclitaxel in the Systemic Circulation Post-injection
To characterize the pharmacokinetics of intratumoral NanoPac, plasma samples were taken on days of NanoPac injection prior to injection and at 1, 2, and 4 hours after NanoPac injection, as well as at all other study visits up through Week 24. Plasma paclitaxel concentrations are reported in pg/mL.
Time frame: Day 1, Weeks 1, 2, 4, 5, 6, 8, 9, 10, 12, 18, and 24
Population: Of the 18 subjects enrolled, one subject in the NanoPac 15 mg/ml - One Injection arm was determined to have non-malignant disease after pathology review following initial injection with NanoPac, and this subject is therefore not included in efficacy assessments but was included in the outcome measure of concentration of paclitaxel in the systemic circulation post-injection. The remaining two subjects in the NanoPac 15 mg/ml - One Injection arm discontinued from the study prior to Week 12.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NanoPac 15 mg/mL | Concentration of Paclitaxel in the Systemic Circulation Post-injection | Week 1 | 2070.0 pg/mL | — |
| NanoPac 15 mg/mL | Concentration of Paclitaxel in the Systemic Circulation Post-injection | Week 18 | 0.0 pg/mL | — |
| NanoPac 15 mg/mL | Concentration of Paclitaxel in the Systemic Circulation Post-injection | Week 8 - Pre-Injection | 0.0 pg/mL | — |
| NanoPac 15 mg/mL | Concentration of Paclitaxel in the Systemic Circulation Post-injection | Week 2 | 810.0 pg/mL | Standard Deviation 1145.51 |
| NanoPac 15 mg/mL | Concentration of Paclitaxel in the Systemic Circulation Post-injection | Day 1 - 2 Hr Post-Injection | 6470.0 pg/mL | Standard Deviation 2757.72 |
| NanoPac 15 mg/mL | Concentration of Paclitaxel in the Systemic Circulation Post-injection | Week 6 | 1060.0 pg/mL | — |
| NanoPac 15 mg/mL | Concentration of Paclitaxel in the Systemic Circulation Post-injection | Week 4 - Pre-Injection | 0.0 pg/mL | — |
| NanoPac 15 mg/mL | Concentration of Paclitaxel in the Systemic Circulation Post-injection | Day 1 - 1 Hr Post-Injection | 10685.0 pg/mL | Standard Deviation 3415.33 |
| NanoPac 15 mg/mL | Concentration of Paclitaxel in the Systemic Circulation Post-injection | Week 12 | 667.0 pg/mL | — |
| NanoPac 15 mg/mL | Concentration of Paclitaxel in the Systemic Circulation Post-injection | Day 1 - 4 Hr Post-Injection | 4360.0 pg/mL | Standard Deviation 1767.77 |
| NanoPac 15 mg/mL | Concentration of Paclitaxel in the Systemic Circulation Post-injection | Week 24 | 589.0 pg/mL | — |
| NanoPac 15 mg/mL | Concentration of Paclitaxel in the Systemic Circulation Post-injection | Day 1 - Pre-Injection | 566.7 pg/mL | Standard Deviation 981.5 |
| NanoPac 15 mg/mL - Two Injections | Concentration of Paclitaxel in the Systemic Circulation Post-injection | Week 10 | 11900.0 pg/mL | — |
| NanoPac 15 mg/mL - Two Injections | Concentration of Paclitaxel in the Systemic Circulation Post-injection | Day 1 - Pre-Injection | 44.2 pg/mL | Standard Deviation 82.61 |
| NanoPac 15 mg/mL - Two Injections | Concentration of Paclitaxel in the Systemic Circulation Post-injection | Day 1 - 1 Hr Post-Injection | 24104.0 pg/mL | Standard Deviation 28642.55 |
| NanoPac 15 mg/mL - Two Injections | Concentration of Paclitaxel in the Systemic Circulation Post-injection | Day 1 - 2 Hr Post-Injection | 21850.0 pg/mL | Standard Deviation 20982.28 |
| NanoPac 15 mg/mL - Two Injections | Concentration of Paclitaxel in the Systemic Circulation Post-injection | Day 1 - 4 Hr Post-Injection | 9877.5 pg/mL | Standard Deviation 8798.58 |
| NanoPac 15 mg/mL - Two Injections | Concentration of Paclitaxel in the Systemic Circulation Post-injection | Week 1 | 3232.0 pg/mL | Standard Deviation 2284.86 |
| NanoPac 15 mg/mL - Two Injections | Concentration of Paclitaxel in the Systemic Circulation Post-injection | Week 2 | 1739.0 pg/mL | Standard Deviation 2011.08 |
| NanoPac 15 mg/mL - Two Injections | Concentration of Paclitaxel in the Systemic Circulation Post-injection | Week 4 - Pre-Injection | 2125.3 pg/mL | Standard Deviation 2056.14 |
| NanoPac 15 mg/mL - Two Injections | Concentration of Paclitaxel in the Systemic Circulation Post-injection | Week 5 | 2662.0 pg/mL | Standard Deviation 1977.22 |
| NanoPac 15 mg/mL - Two Injections | Concentration of Paclitaxel in the Systemic Circulation Post-injection | Week 6 | 21640.0 pg/mL | Standard Deviation 28369.12 |
| NanoPac 15 mg/mL - Two Injections | Concentration of Paclitaxel in the Systemic Circulation Post-injection | Week 8 - Pre-Injection | 7976.3 pg/mL | Standard Deviation 12147.98 |
| NanoPac 15 mg/mL - Two Injections | Concentration of Paclitaxel in the Systemic Circulation Post-injection | Week 9 | 17695.0 pg/mL | Standard Deviation 16977.63 |
| NanoPac 15 mg/mL - Two Injections | Concentration of Paclitaxel in the Systemic Circulation Post-injection | Week 12 | 7953.5 pg/mL | Standard Deviation 10955.21 |
| NanoPac 15 mg/mL - Two Injections | Concentration of Paclitaxel in the Systemic Circulation Post-injection | Week 18 | 4910.5 pg/mL | Standard Deviation 6801.66 |
| NanoPac 15 mg/mL - Two Injections | Concentration of Paclitaxel in the Systemic Circulation Post-injection | Week 24 | 5770.1 pg/mL | Standard Deviation 8103.37 |
| NanoPac 15 mg/mL - Three Injections | Concentration of Paclitaxel in the Systemic Circulation Post-injection | Week 24 | 10.6 pg/mL | Standard Deviation 23.75 |
| NanoPac 15 mg/mL - Three Injections | Concentration of Paclitaxel in the Systemic Circulation Post-injection | Week 8 - Pre-Injection | 702.5 pg/mL | Standard Deviation 1171.64 |
| NanoPac 15 mg/mL - Three Injections | Concentration of Paclitaxel in the Systemic Circulation Post-injection | Week 18 | 80.7 pg/mL | Standard Deviation 176.92 |
| NanoPac 15 mg/mL - Three Injections | Concentration of Paclitaxel in the Systemic Circulation Post-injection | Week 9 | 1951.5 pg/mL | Standard Deviation 4991.29 |
| NanoPac 15 mg/mL - Three Injections | Concentration of Paclitaxel in the Systemic Circulation Post-injection | Day 1 - 4 Hr Post-Injection | 25884.8 pg/mL | Standard Deviation 46389.73 |
| NanoPac 15 mg/mL - Three Injections | Concentration of Paclitaxel in the Systemic Circulation Post-injection | Week 10 | 1813.1 pg/mL | Standard Deviation 2291.7 |
| NanoPac 15 mg/mL - Three Injections | Concentration of Paclitaxel in the Systemic Circulation Post-injection | Day 1 - 2 Hr Post-Injection | 27678.1 pg/mL | Standard Deviation 49332.88 |
| NanoPac 15 mg/mL - Three Injections | Concentration of Paclitaxel in the Systemic Circulation Post-injection | Day 1 - Pre-Injection | 32.8 pg/mL | Standard Deviation 103.72 |
| NanoPac 15 mg/mL - Three Injections | Concentration of Paclitaxel in the Systemic Circulation Post-injection | Week 4 - Pre-Injection | 863.7 pg/mL | Standard Deviation 1319.34 |
| NanoPac 15 mg/mL - Three Injections | Concentration of Paclitaxel in the Systemic Circulation Post-injection | Week 12 | 551.9 pg/mL | Standard Deviation 980.98 |
| NanoPac 15 mg/mL - Three Injections | Concentration of Paclitaxel in the Systemic Circulation Post-injection | Week 5 | 1933.5 pg/mL | Standard Deviation 3036.68 |
| NanoPac 15 mg/mL - Three Injections | Concentration of Paclitaxel in the Systemic Circulation Post-injection | Week 2 | 10215.3 pg/mL | Standard Deviation 28268.21 |
| NanoPac 15 mg/mL - Three Injections | Concentration of Paclitaxel in the Systemic Circulation Post-injection | Day 1 - 1 Hr Post-Injection | 45523.7 pg/mL | Standard Deviation 93639.03 |
| NanoPac 15 mg/mL - Three Injections | Concentration of Paclitaxel in the Systemic Circulation Post-injection | Week 6 | 1357.1 pg/mL | Standard Deviation 2031.87 |
| NanoPac 15 mg/mL - Three Injections | Concentration of Paclitaxel in the Systemic Circulation Post-injection | Week 1 | 2399.3 pg/mL | Standard Deviation 3981.41 |
Secondary
Overall Survival
Overall survival (OS) as determined by survival time following first NanoPac injection
Time frame: Weeks 24, 38, and 52
Population: Of the 18 subjects enrolled, one subject was determined to have non-malignant disease after pathology review following initial injection with NanoPac, and this subject is therefore not included in efficacy assessments i.e. overall survival.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| NanoPac 15 mg/mL | Overall Survival | Week 38 | Confirmed Alive | 0 Participants |
| NanoPac 15 mg/mL | Overall Survival | Week 52 | Confirmed Alive | 0 Participants |
| NanoPac 15 mg/mL | Overall Survival | Week 52 | Censored | 1 Participants |
| NanoPac 15 mg/mL | Overall Survival | Week 38 | Censored | 1 Participants |
| NanoPac 15 mg/mL | Overall Survival | Week 38 | Dead | 1 Participants |
| NanoPac 15 mg/mL | Overall Survival | Week 24 | Dead | 1 Participants |
| NanoPac 15 mg/mL | Overall Survival | Week 24 | Confirmed Alive | 0 Participants |
| NanoPac 15 mg/mL | Overall Survival | Week 52 | Dead | 1 Participants |
| NanoPac 15 mg/mL | Overall Survival | Week 24 | Censored | 1 Participants |
| NanoPac 15 mg/mL - Two Injections | Overall Survival | Week 38 | Dead | 2 Participants |
| NanoPac 15 mg/mL - Two Injections | Overall Survival | Week 24 | Confirmed Alive | 3 Participants |
| NanoPac 15 mg/mL - Two Injections | Overall Survival | Week 24 | Dead | 2 Participants |
| NanoPac 15 mg/mL - Two Injections | Overall Survival | Week 24 | Censored | 0 Participants |
| NanoPac 15 mg/mL - Two Injections | Overall Survival | Week 38 | Confirmed Alive | 3 Participants |
| NanoPac 15 mg/mL - Two Injections | Overall Survival | Week 38 | Censored | 0 Participants |
| NanoPac 15 mg/mL - Two Injections | Overall Survival | Week 52 | Confirmed Alive | 1 Participants |
| NanoPac 15 mg/mL - Two Injections | Overall Survival | Week 52 | Dead | 3 Participants |
| NanoPac 15 mg/mL - Two Injections | Overall Survival | Week 52 | Censored | 1 Participants |
| NanoPac 15 mg/mL - Three Injections | Overall Survival | Week 24 | Censored | 1 Participants |
| NanoPac 15 mg/mL - Three Injections | Overall Survival | Week 24 | Confirmed Alive | 6 Participants |
| NanoPac 15 mg/mL - Three Injections | Overall Survival | Week 52 | Confirmed Alive | 2 Participants |
| NanoPac 15 mg/mL - Three Injections | Overall Survival | Week 24 | Dead | 3 Participants |
| NanoPac 15 mg/mL - Three Injections | Overall Survival | Week 52 | Censored | 2 Participants |
| NanoPac 15 mg/mL - Three Injections | Overall Survival | Week 38 | Dead | 5 Participants |
| NanoPac 15 mg/mL - Three Injections | Overall Survival | Week 38 | Confirmed Alive | 4 Participants |
| NanoPac 15 mg/mL - Three Injections | Overall Survival | Week 52 | Dead | 6 Participants |
| NanoPac 15 mg/mL - Three Injections | Overall Survival | Week 38 | Censored | 1 Participants |
Secondary
Progression Free Survival (PFS)
Progression free survival (PFS) as assessed using RECIST v1.1
Time frame: Weeks 24, 38, and 52
Population: Of the 18 subjects enrolled, one subject was determined to have non-malignant disease after pathology review following initial injection with NanoPac, and this subject is therefore not included in efficacy assessments i.e. PFS.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| NanoPac 15 mg/mL | Progression Free Survival (PFS) | Week 38 | Progression Free | 0 Participants |
| NanoPac 15 mg/mL | Progression Free Survival (PFS) | Week 52 | Censored | 0 Participants |
| NanoPac 15 mg/mL | Progression Free Survival (PFS) | Week 38 | Censored | 0 Participants |
| NanoPac 15 mg/mL | Progression Free Survival (PFS) | Week 38 | Progressed or Died | 2 Participants |
| NanoPac 15 mg/mL | Progression Free Survival (PFS) | Week 24 | Progression Free | 0 Participants |
| NanoPac 15 mg/mL | Progression Free Survival (PFS) | Week 52 | Progressed or Died | 2 Participants |
| NanoPac 15 mg/mL | Progression Free Survival (PFS) | Week 24 | Censored | 0 Participants |
| NanoPac 15 mg/mL | Progression Free Survival (PFS) | Week 24 | Progressed or Died | 2 Participants |
| NanoPac 15 mg/mL | Progression Free Survival (PFS) | Week 52 | Progression Free | 0 Participants |
| NanoPac 15 mg/mL - Two Injections | Progression Free Survival (PFS) | Week 38 | Progressed or Died | 5 Participants |
| NanoPac 15 mg/mL - Two Injections | Progression Free Survival (PFS) | Week 24 | Progression Free | 0 Participants |
| NanoPac 15 mg/mL - Two Injections | Progression Free Survival (PFS) | Week 24 | Progressed or Died | 5 Participants |
| NanoPac 15 mg/mL - Two Injections | Progression Free Survival (PFS) | Week 24 | Censored | 0 Participants |
| NanoPac 15 mg/mL - Two Injections | Progression Free Survival (PFS) | Week 38 | Progression Free | 0 Participants |
| NanoPac 15 mg/mL - Two Injections | Progression Free Survival (PFS) | Week 38 | Censored | 0 Participants |
| NanoPac 15 mg/mL - Two Injections | Progression Free Survival (PFS) | Week 52 | Progression Free | 0 Participants |
| NanoPac 15 mg/mL - Two Injections | Progression Free Survival (PFS) | Week 52 | Progressed or Died | 5 Participants |
| NanoPac 15 mg/mL - Two Injections | Progression Free Survival (PFS) | Week 52 | Censored | 0 Participants |
| NanoPac 15 mg/mL - Three Injections | Progression Free Survival (PFS) | Week 24 | Censored | 1 Participants |
| NanoPac 15 mg/mL - Three Injections | Progression Free Survival (PFS) | Week 24 | Progression Free | 5 Participants |
| NanoPac 15 mg/mL - Three Injections | Progression Free Survival (PFS) | Week 52 | Progression Free | 2 Participants |
| NanoPac 15 mg/mL - Three Injections | Progression Free Survival (PFS) | Week 24 | Progressed or Died | 4 Participants |
| NanoPac 15 mg/mL - Three Injections | Progression Free Survival (PFS) | Week 52 | Censored | 2 Participants |
| NanoPac 15 mg/mL - Three Injections | Progression Free Survival (PFS) | Week 38 | Progressed or Died | 5 Participants |
| NanoPac 15 mg/mL - Three Injections | Progression Free Survival (PFS) | Week 38 | Progression Free | 4 Participants |
| NanoPac 15 mg/mL - Three Injections | Progression Free Survival (PFS) | Week 52 | Progressed or Died | 6 Participants |
| NanoPac 15 mg/mL - Three Injections | Progression Free Survival (PFS) | Week 38 | Censored | 1 Participants |