Advanced Solid TumorPhase 1NCT02979392
Phase I Study of TENPA in Advanced Solid Cancer
A Phase 1 study testing TENPA (Targeting-Enhancing Nanoparticles of Paclitaxel) in people with Advanced Solid Tumor, run by Yung-Jue Bang at 1 site in South Korea.
Trial summary
The purpose of this study is to investigate the safety and to determine maximum tolerated dose and recommended phase 2 dose of TENPA (Targeting-Enhancing Nanoparticles of Paclitaxel) in patients with advanced solid tumor. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- TENPA (Targeting-Enhancing Nanoparticles of Paclitaxel)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 May 2016to 4 Jul 2019
- Phase
- Phase 1
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to provide written informed consent for voluntary participation in the trial
- Twenty years of age or older on the day of signing informed consent
- Advanced solid tumors with no standard treatment available
- Evaluable disease or have measurable lesion
- ECOG performance score of 0 or 1
- Life expectancy ≥ 12 weeks
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- Adequate organ and marrow function as defined below:
- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L (> 1500 per mm3) B. Haemoglobin ≥ 8.0 g/dL C. Platelet count ≥ 100 x 109/L (>100,000 per mm3) D. AST (SGOT)/ALT (SGPT) ≤ 2.5 x institutional ULN E. Serum bilirubin ≤ 2 x institutional upper limit of normal (ULN) F. Serum creatinine ≤ 1.5 mg/dL
- Adequate heart function A. QT interval corrected for heart rate (QTc) ≤ 480 ms
- In the opinion of the investigator likely to have the willingness to comply with the study protocol during and after the study period and capable of complying with it
- Negative serum pregnancy test (β HCG) upon study entry and agree to use contraception
Who cannot join
- Uncontrolled CNS metastatic disease (radiographically unstable and symptomatic disease). (note) Subjects with previously treated CNS metastases (surgery or stereotactic brain radiation therapy) that are radiographically stable for at least 4 weeks are permitted to enroll. Subjects should not receive corticosteroids within 3 weeks prior to study enrollment.
- History of leptomeningeal carcinomatosis; brain metastasis with seizure not controlled with standard medical management.
- Major surgery within 4 weeks: patient must have recovered from any effects of any major surgery.
- History of hematopoietic stem cell transplantation or solid organ transplantation
- History of Gilbert's syndrome
- Prior malignancy except:
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- Basal cell carcinoma and squamous cell carcinoma of the skin that has undergone potentially curative surgery, in situ cervical cancer that has undergone potentially curative surgery and had no evidence of recurrence at least in past 3 years, other malignancy that has undergone curative surgery and had no evidence of disease at least in past 5 years.
- Significant cardiovascular disease, such as: history of myocardial infarction, acute coronary syndrome or coronary angioplasty/stenting/bypass grafting within the last 6 months; History or current evidence of clinically significant arrhythmia or conduction disorder, except symptomatic congestive heart failure (CHR), atrial fibrillation, and paroxysmal supraventricular tachycardia (PSVT)
- Sustained uncontrolled hypertension
- Test results indicating active infection with human immunodeficiency virus (HIR) or hepatitis B or C, defined by positive serology testing (note) inactive hepatitis B carrier on antiviral agents are permitted to enroll.
- Neuromuscular disorder associated with CK elevation (eg. Inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, and spinobulbar muscular atrophy)
- Uncontrolled intercurrent illness or symptoms including, but not limited to, ongoing or active infection, bowel obstruction, psychiatric illness/social situations that would limit compliance with study requirement.
- Radiation therapy within 2 weeks of the first dose of study drug: patient must have recovered from any effects of radiation therapy
- Pregnant or breast feeding.
- Female subjects of childbearing potential within the projected duration of the study, starting with the screening visit through 30 days after the last dose of study drug.
- Female of childbearing potential are defined as those who are not surgically sterile (i.3., bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or who are not postmenopausal (defined as 12 months with no menses without an alternative medical cause). Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control.
- Non-sterilized males who are sexually active with a female partner of child bearing potential from screening through 30 days after receipt of the final dose of study drug.
- Any medical, psychiatric or cognitive disorder that compromise the ability of the subject to give informed consent, comply with the study protocol, and complete the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Open-label, Dose Escalation (Part A), Cohort Expansion (Part B) Phase I Study to Investigate the Safety and to Determine Maximum Tolerated Dose and Recommended Phase 2 Dose of TENPA (Targeting-Enhancing Nanoparticles of Paclitaxel) in Patients With Advanced Solid Tumor
The purpose of this study is to investigate the safety and to determine maximum tolerated dose and recommended phase 2 dose of TENPA (Targeting-Enhancing Nanoparticles of Paclitaxel) in patients with advanced solid tumor.
- Conditions
- Advanced Solid Tumor
- Being tested
- TENPA (Targeting-Enhancing Nanoparticles of Paclitaxel)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TENPA (Targeting-Enhancing Nanoparticles of Paclitaxel)Drug
TENPA IV once every 3 weeks (Phase I starting dose 75 mg/m2)
| Study group | Role | What they receive |
|---|---|---|
| Phase I | Experimental | Part A, Dose escalation TENPA (Targeting-Enhancing Nanoparticles of Paclitaxel) IV once every 3 weeks (Phase I starting dose 75 mg/m2) Part B, Expansion TENPA (Targeting-Enhancing Nanoparticles of Paclitaxel) IV once every 3 weeks (RP2D dose determined in part A) Receives: Drug: TENPA (Targeting-Enhancing Nanoparticles of Paclitaxel) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicity (DLT)
Measured: at least one cycle of treatment (3 weeks)
Maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D)
Measured: at least one cycle of treatment (3 weeks)
Secondary outcomes (4)
Maximum Plasma Concentration [Cmax]
Measured: 3 weeks
Area Under the Curve [AUC]
Measured: 3 weeks
Response rate (RR)
Measured: 6 weeks
Progression-free survival (PFS)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2016 (estimated)
- Study start2 May 2016
- Primary completion4 Jul 2019
- Study completion4 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yung-Jue Bang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yung-Jue Bang, Seoul National University Hospital
- Investigators
- Yung-Jue Bang, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02979392
- Sponsor's protocol ID
- H1604-140-758
- Status last verified
- Sep 2019
- First submitted
- 27 Nov 2016
- Last updated
- 25 Sep 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-label, Dose Escalation (Part A), Cohort Expansion (Part B) Phase I Study to Investigate the Safety and to Determine Maximum Tolerated Dose and Recommended Phase 2 Dose of TENPA (Targeting-Enhancing Nanoparticles of Paclitaxel) in Patients With Advanced Solid Tumor
- ClinicalTrials.gov ID
- NCT02979392
- Acronym / sponsor ID
- H1604-140-758
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Yung-Jue BangUniversity, hospital or other
- Study start
- 2 May 2016 (actual)
- Primary completion
- 4 Jul 2019 (actual)
- Study completion
- 4 Jul 2019 (actual)
- First posted
- 1 Dec 2016 (estimated)
- 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 purpose of this study is to investigate the safety and to determine maximum tolerated dose and recommended phase 2 dose of TENPA (Targeting-Enhancing Nanoparticles of Paclitaxel) in patients with advanced solid tumor.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Phase I | Experimental | Drug: TENPA (Targeting-Enhancing Nanoparticles of Paclitaxel)Part A, Dose escalation TENPA (Targeting-Enhancing Nanoparticles of Paclitaxel) IV once every 3 weeks (Phase I starting dose 75 mg/m2) Part B, Expansion TENPA (Targeting-Enhancing Nanoparticles of Paclitaxel) IV once every 3 weeks (RP2D dose determined in part A) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Willing and able to provide written informed consent for voluntary participation in the trial
- Twenty years of age or older on the day of signing informed consent
- Advanced solid tumors with no standard treatment available
- Evaluable disease or have measurable lesion
- ECOG performance score of 0 or 1
Key exclusion criteria (18 listed)
- Uncontrolled CNS metastatic disease (radiographically unstable and symptomatic disease). (note) Subjects with previously treated CNS metastases (surgery or stereotactic brain radiation therapy) that are radiographically stable for at least 4 weeks are permitted to enroll. Subjects should not receive corticosteroids within 3 weeks prior to study enrollment.
- History of leptomeningeal carcinomatosis; brain metastasis with seizure not controlled with standard medical management.
- Major surgery within 4 weeks: patient must have recovered from any effects of any major surgery.
- History of hematopoietic stem cell transplantation or solid organ transplantation
- History of Gilbert's syndrome
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 |
|---|---|---|
| TENPA (Targeting-Enhancing Nanoparticles of Paclitaxel)TENPA IV once every 3 weeks (Phase I starting dose 75 mg/m2) | Drug | Phase I |
Primary outcome
Dose limiting toxicity (DLT)
Time frame: at least one cycle of treatment (3 weeks)
Maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D)
Time frame: at least one cycle of treatment (3 weeks)
4 secondary outcomes
Maximum Plasma Concentration [Cmax]
Time frame: 3 weeks
Area Under the Curve [AUC]
Time frame: 3 weeks
Response rate (RR)
Time frame: 6 weeks
Progression-free survival (PFS)
Time frame: 6 weeks
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
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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.
Yung-Jue Bang principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TENPA (Targeting-Enhancing Nanoparticles of Paclitaxel) in people with Advanced Solid Tumor, run by Yung-Jue Bang at 1 site in South Korea.
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 18 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: stopped early, as of the sponsor's last update on 25 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
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?
Dose limiting toxicity (DLT) (time frame: at least one cycle of treatment (3 weeks)). 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?
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 25 Sep 2019.