Advanced Solid MalignanciesPhase 1NCT01103791
A Trial to Determine the Maximum Tolerated Dose and Evaluate the Safety and Pharmacokinetics of Docetaxel-PNP, Polymeric Nanoparticle Formulation of Docetaxel, in Subjects With Advanced Solid Malignancies
A Phase 1 study testing Docetaxel-PNP in people with Advanced Solid Malignancies, run by Samyang Biopharmaceuticals Corporation at 1 site in South Korea.
Trial summary
This is a phase I trial to determine the maximum tolerated dose and recommended phase II dose of docetaxel-PNP (polymeric nanoparticle formulation of docetaxel) and to evaluate the safety and pharmacokinetics of docetaxel-PNP in subjects with advanced solid malignancies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Malignancies
- What is being tested?
- Docetaxel-PNP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2010to Apr 2012
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient ages more than 18 years old
- Patient should voluntarily sign a written informed consent before study entry
- Patient historically or cytologically confirmed diagnosis of advanced solid tumor and patient with measurable disease or evaluable disease by RECIST criteria
- Progressive disease with development of new lesions or an increase in preexisting lesions or standard therapy in order to provide clinical benefit does not exist or is no longer effective
- Previous anti-cancer therapies must be completed before 21days of first study dose and Patient must have recovered from any previous therapy
- Patient has an Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
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- Patient has a life expectancy of at least 3 months
- Baseline studies for determining eligibility must be completed within 14 days of first study dose and patient has a adequate organ function including the following:
- Hb ≥ 10g/dl
- ANC ≥ 1.5 X 109/L
- Platelet count ≥ 100 X 109/L
- Serum total bilirubin ≤ 1.5 mg/dL
- Serum AST and ALT ≤ 2.5 X UNL
- Serum ALP ≤ 2.5ⅹUNL
- Serum creatinine ≤ 1.5 X UNL
Who cannot join
- Patient has had a major surgery except tumor ablation within 2 weeks before screening visit
- Patient has a brain metastasis with neurologic symptom
- Patient has a sensory neuropathy or motor neuropathy ≥ grade 2 by NCI-CTCAE
- Patient has any serious concurrent disease such as:
- Any medical or psychiatric condition that, in the opinion of the investigator, would prohibit the understanding and giving of informed consent Severe cardiovascular disease (e.g. ischemic heart disease requiring medication or myocardial infraction within the past six months, grade 3-4 congestive heart failure defined by the New York Heart Association criteria) Active un controlled infection.
- Patient has hypersensitivity to the Investigational product or their excipients
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- Patient has participated in any other clinical trial within 4 weeks before screening visit
- Woman is pregnant or breast feeding
- Subjects who are of childbearing potential who do not use a medically acceptable method of birth control or do not agree to continue use of this method throughout the trial (screening, treatment period, and 3 weeks from the last done). A negative pregnancy test (urine or serum) should be documented within 14 days prior to initiation of trial medication for women of childbearing potential who have not been amenorrheic for at least 12 months prior to registration into the trial or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy). Medically acceptable methods include:
- Barrier method with spermicide
- Intrauterine device
- Complete abstinence, etc.
- Patient who has a history of resistance, intolerance, or no response to Docetaxel therapy
Trial locations and contacts
1 site in 1 country.
About this study
This is a phase I trial to determine the maximum tolerated dose and recommended phase II dose of docetaxel-PNP (polymeric nanoparticle formulation of docetaxel) and to evaluate the safety and pharmacokinetics of docetaxel-PNP in subjects with advanced solid malignancies.
- Conditions
- Advanced Solid Malignancies
- Being tested
- Docetaxel-PNP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Docetaxel-PNPDrug
Docetaxel-PNP, Polymeric Nanoparticle Formulation of Docetaxel
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Docetaxel-PNP 20mg/m2 Receives: Drug: Docetaxel-PNP |
| Cohort 2 | Experimental | Docetaxel-PNP 35mg/m2 Receives: Drug: Docetaxel-PNP |
| Cohort 3 | Experimental | Docetaxel-PNP 45mg/m2 Receives: Drug: Docetaxel-PNP |
| Cohort 4 | Experimental | Docetaxel-PNP 60mg/m2 Receives: Drug: Docetaxel-PNP |
| Cohort 5 | Experimental | Docetaxel-PNP 75mg/m2 Receives: Drug: Docetaxel-PNP |
| Cohort 6 | Experimental | Docetaxel-PNP 90mg/m2 Receives: Drug: Docetaxel-PNP |
What is being measured
The primary outcome is the main question the study is designed to answer.
The maximum tolerated dose (MTD) of Docetaxel-PNP
Administration of docetaxel-PNP was well tolerated up 6mg/m² every 3weeks by heavily pretreated patients.
Measured: up to 6 cycle
The recommended phase II dose of Docetaxel-PNP
Futher phase Ⅱ Trials are recommended at this dose level
Measured: up to 6 cycle
Secondary outcomes (3)
The Dose Limiting Toxicity (DLT)
Measured: up to 6 cycle
The pharmacokinetics of Docetaxel-PNP on Day 1 of 1st cycle (AUC, CL, T1/2, Tmax, Cmax, Vdss)
Measured: up to 6 cycle
Objective response rate
Measured: up to 6 cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionSep 2011
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid MalignanciesStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samyang Biopharmaceuticals Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kyung Hae Jung, Ph. D., Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01103791
- Sponsor's protocol ID
- DOPNP101
- Status last verified
- May 2017
- First submitted
- 5 Apr 2010
- Last updated
- 5 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial to Determine the Maximum Tolerated Dose and Evaluate the Safety and Pharmacokinetics of Docetaxel-PNP, Polymeric Nanoparticle Formulation of Docetaxel, in Subjects With Advanced Solid Malignancies
- ClinicalTrials.gov ID
- NCT01103791
- Acronym / sponsor ID
- DOPNP101
- Conditions
- Advanced Solid Malignancies
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Samyang Biopharmaceuticals CorporationIndustry (pharma, biotech, devices)
- Study start
- Apr 2010 (actual)
- Primary completion
- Sep 2011 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 15 Apr 2010 (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.
This is a phase I trial to determine the maximum tolerated dose and recommended phase II dose of docetaxel-PNP (polymeric nanoparticle formulation of docetaxel) and to evaluate the safety and pharmacokinetics of docetaxel-PNP in subjects with advanced solid malignancies.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: Docetaxel-PNPDocetaxel-PNP 20mg/m2 |
| Cohort 2 | Experimental | Drug: Docetaxel-PNPDocetaxel-PNP 35mg/m2 |
| Cohort 3 | Experimental | Drug: Docetaxel-PNPDocetaxel-PNP 45mg/m2 |
| Cohort 4 | Experimental | Drug: Docetaxel-PNPDocetaxel-PNP 60mg/m2 |
| Cohort 5 | Experimental | Drug: Docetaxel-PNPDocetaxel-PNP 75mg/m2 |
| Cohort 6 | Experimental | Drug: Docetaxel-PNPDocetaxel-PNP 90mg/m2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patient ages more than 18 years old
- Patient should voluntarily sign a written informed consent before study entry
- Patient historically or cytologically confirmed diagnosis of advanced solid tumor and patient with measurable disease or evaluable disease by RECIST criteria
- Progressive disease with development of new lesions or an increase in preexisting lesions or standard therapy in order to provide clinical benefit does not exist or is no longer effective
- Previous anti-cancer therapies must be completed before 21days of first study dose and Patient must have recovered from any previous therapy
Key exclusion criteria (13 listed)
- Patient has had a major surgery except tumor ablation within 2 weeks before screening visit
- Patient has a brain metastasis with neurologic symptom
- Patient has a sensory neuropathy or motor neuropathy ≥ grade 2 by NCI-CTCAE
- Patient has any serious concurrent disease such as:
- Any medical or psychiatric condition that, in the opinion of the investigator, would prohibit the understanding and giving of informed consent Severe cardiovascular disease (e.g. ischemic heart disease requiring medication or myocardial infraction within the past six months, grade 3-4 congestive heart failure defined by the New York Heart Association criteria) Active un controlled infection.
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 |
|---|---|---|
| Docetaxel-PNPDocetaxel-PNP, Polymeric Nanoparticle Formulation of Docetaxel | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6 |
Primary outcome
The maximum tolerated dose (MTD) of Docetaxel-PNP
Time frame: up to 6 cycle
Administration of docetaxel-PNP was well tolerated up 6mg/m² every 3weeks by heavily pretreated patients.
The recommended phase II dose of Docetaxel-PNP
Time frame: up to 6 cycle
Futher phase Ⅱ Trials are recommended at this dose level
3 secondary outcomes
The Dose Limiting Toxicity (DLT)
Time frame: up to 6 cycle
The pharmacokinetics of Docetaxel-PNP on Day 1 of 1st cycle (AUC, CL, T1/2, Tmax, Cmax, Vdss)
Time frame: up to 6 cycle
Objective response rate
Time frame: up to 6 cycle
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2017.
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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.
Kyung Hae Jung, Ph. D. principal investigator
Asan Medical Center
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 Docetaxel-PNP in people with Advanced Solid Malignancies, run by Samyang Biopharmaceuticals Corporation 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 15 inclusion and 13 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 5 May 2017. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The maximum tolerated dose (MTD) of Docetaxel-PNP (time frame: up to 6 cycle). 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 5 May 2017.