Advanced CancerPhase 1NCT01611961
Docetaxel Lipid Microsphere (DT-LM) for Injection in Chemotherapy Patients
A Phase 1 study testing DT-LM and docetaxel in people with Advanced Cancer, run by Shenyang Pharmaceutical University at 1 site in China.
Trial summary
Docetaxel Lipid Microsphere (DT-LM) is a novel proprietary delivery system of docetaxel developed by Shenyang Pharmaceutical University. In this Phase I study, the DT-LM was evaluated for the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) in patients with advance solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- DT-LM and docetaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteChina
- Study dates
- Aug 2012to Dec 2014
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 and < 65, with ECOG performance status 0-1,and Life expectancy of more than 3 months.
- Have advanced (local and/or metastatic) histologically documented cancer considered unresponsive to available conventional modalities or treatments.
- Have recovered from acute toxicities of prior treatment:
- 4 weeks must have elapsed since receiving any investigational agent.
- 4 weeks must have elapsed since receiving any radiotherapy, or treatment with cytotoxic or biologic agents (≥6 weeks for mitomycin or nitrosoureas).
- 4 weeks must have elapsed since any prior surgery.
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- Be in adequate condition as evidenced by the following clinical laboratory values:
- Absolute neutrophil count (ANC) ≥1,500/mm3.
- Platelets ≥ 80,000/mm3.
- Hemoglobin ≥ 9.0 g/dL.
- WBC ≥ 4,000/mm3.
- Total bilirubin ≤ 2.5 x institutional upper limit normal (ULN).
- Transaminases AST (SGOT) and ALT (SGPT) ≤ 1.5 times ULN or ≤ 5 times ULN (liver metastasis).
- Serum creatinine ≤ 1.2 times ULN, blood urea nitrogen≤ 1.2 times ULN.
- both female and male patients must use adequate methods of contraception.
- Patient or legal representative must understand the investigational nature of this study and sign an Institutional Review Board (IRB)/Independent Ethics Committee approved written informed consent form prior to treatment.
Who cannot join
- Intolerance to any antineoplastic agents belonging to the taxoid family.
- having failed a docetaxel-containing regimen or Having known non-controllable hypersensitivity to docetaxel or lipid microsphere.
- Active uncontrolled bleeding or bleeding diathesis (e.g., active peptic ulcer disease).
- Unstable or uncontrolled cardiac disease or hypertension.
- With other serious internal diseases, uncontrolled infection or uncontrolled diabetes.
- With Symptomatic brain metastasis not controlled.
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- Having pre-existing clinically significant neuropathy (NCI CTCAE Grade ≥ 2 neuromotor or Grade ≥ 2 neurosensory) except for abnormalities due to cancer.
- Currently receiving any other standard or investigational treatment for cancer or any other investigational agent for any indication.
- Requiring immediate palliative treatment of any kind including surgery and/or radiotherapy.
- Female patients who are pregnant or breast-feeding.
- Unwilling or unable to follow protocol requirements.
- With history of serious allergic or allergy.
- Not fit for the clinical trial judged by the investigator.
Trial locations and contacts
1 site in 1 country.
Yuankai Shi contact
China1 site, 1 recruiting
- Recruiting
Cancer Institute & Hospital, Chinese Academy of Medical Sciences
Beijing, 100021
Yuankai Shi, 86-10-87788121
Yuankai Shi, Professor
About this study
Official title: A Phase I Study to Assess the Safety, Tolerability and Pharmacokinetics of Docetaxel Lipid Microsphere for Injection in Cancer Patients Receiving Chemotherapy
Docetaxel Lipid Microsphere (DT-LM) is a novel proprietary delivery system of docetaxel developed by Shenyang Pharmaceutical University. In this Phase I study, the DT-LM was evaluated for the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) in patients with advance solid tumors. It was also evaluated for pharmacokinetic and anti-tumor effects of DT-LM compared to commerical docetaxel.
Read the detailed description
Docetaxel (currently marketed as Taxotere®), given by intravenous or intraperitoneal injection, has contributed significantly to the treatment of a variety of malignancies, such as ovarian, breast, gastric, and non-small-cell lung cancer (NSCLC), as well as head and neck cancer and some other cancers. In the preclinical, DT-LM showed reduced toxicity (especially myelosuppression）and comparable therapeutic efficacy. In clinic, it is believed that DT-LM will offer fewer side effects to the patient at similar doses, and possibly greater effectiveness when used at higher doses. DT-LM could not only avoid the serious hypersensitivity reactions caused by Tween 80, but also be stable, safe and convenient for clinical administration.
This study is designed to determine the following:
- The maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of DT-LM.
- The pharmacokinetics of docetaxel following intravenous administration of DT-LM.
- Any anti-tumor effects of DT-LM.
Controlled trial is also carrying out to reveal the differences in safety, pharmacokinetics and pharmacodynamics between DT-LM and Taxotere.
- Conditions
- Advanced Cancer
- Being tested
- DT-LM, docetaxel
- Keywords
- Docetaxel, Lipid Microsphere, Neoplasms, Antineoplastic Agents, Pharmacologic Actions, Therapeutic Uses
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DT-LMDrug
Also called Docetaxel Lipid Microsphere
Intravenous infusion, Upto 6 dose levels have been studied i.e. 45, 60, 75, 90 105,and 120 mg/m2, Every 3 weeks.
docetaxelDrug
Also called Taxotere
Intravenous infusion, 3 dose levels：60, 75, and 90 mg/m2, Every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| DT-LM | Experimental | Docetaxel Lipid Microsphere (DT-LM) Receives: Drug: DT-LM |
| Taxotere | Active comparator | Commerical Product Receives: Drug: docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
The safety and tolerability
This Phase I, open-label, control,dose-escalation study was designed to determine the maximum tolerated dose (MTD) of DT-LM in patients with advanced cancer. DT-LM was administered by intravenous infusion, over 1 hour, once every 21 days until occurrence of disease progression or toxicity requiring early treatment discontinuation. Dose escalation was not done until the safety and tolerability at a given dose level has been confirmed.
Measured: one year
Secondary outcomes (2)
Assessment of pharmacokinetics of DT-LM and Taxotere: AUC and Cmax
The patients were evaluated for pharmacokinetic profile of DT-LM and Taxotere upto 48 hours post treatment after cycle 1 and cycle 2,respectively.
Measured: one year
Objective tumour response according to RECIST
The anti-tumor effects were evaluated after every two cycles of treatment.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2012 (estimated)
- Study startAug 2012
- Primary completionSep 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies 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
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenyang Pharmaceutical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shi Yuankai, Ph.D, Chinese Academy of Medical Sciences
- Investigators
- Xing Tang, Ph.D, Study director, Shenyang Pharmaceutical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01611961
- Sponsor's protocol ID
- SYPHU-DT-LM-01
- Status last verified
- Sep 2014
- First submitted
- 29 May 2012
- Last updated
- 30 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Assess the Safety, Tolerability and Pharmacokinetics of Docetaxel Lipid Microsphere for Injection in Cancer Patients Receiving Chemotherapy
- ClinicalTrials.gov ID
- NCT01611961
- Acronym / sponsor ID
- SYPHU-DT-LM-01
- Conditions
- Advanced Cancer
- Keywords
- Docetaxel, Lipid Microsphere, Neoplasms, Antineoplastic Agents, Pharmacologic Actions, Therapeutic Uses
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Shenyang Pharmaceutical UniversityUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 5 Jun 2012 (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.
Docetaxel Lipid Microsphere (DT-LM) is a novel proprietary delivery system of docetaxel developed by Shenyang Pharmaceutical University. In this Phase I study, the DT-LM was evaluated for the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) in patients with advance solid tumors. It was also evaluated for pharmacokinetic and anti-tumor effects of DT-LM compared to commerical docetaxel.
Detailed description
Docetaxel (currently marketed as Taxotere®), given by intravenous or intraperitoneal injection, has contributed significantly to the treatment of a variety of malignancies, such as ovarian, breast, gastric, and non-small-cell lung cancer (NSCLC), as well as head and neck cancer and some other cancers. In the preclinical, DT-LM showed reduced toxicity (especially myelosuppression）and comparable therapeutic efficacy. In clinic, it is believed that DT-LM will offer fewer side effects to the patient at similar doses, and possibly greater effectiveness when used at higher doses. DT-LM could not only avoid the serious hypersensitivity reactions caused by Tween 80, but also be stable, safe and convenient for clinical administration.
This study is designed to determine the following:
- The maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of DT-LM.
- The pharmacokinetics of docetaxel following intravenous administration of DT-LM.
- Any anti-tumor effects of DT-LM.
Controlled trial is also carrying out to reveal the differences in safety, pharmacokinetics and pharmacodynamics between DT-LM and Taxotere.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DT-LM | Experimental | Drug: DT-LMDocetaxel Lipid Microsphere (DT-LM) |
| Taxotere | Active comparator | Drug: docetaxelCommerical Product |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Age > 18 and < 65, with ECOG performance status 0-1,and Life expectancy of more than 3 months.
- Have advanced (local and/or metastatic) histologically documented cancer considered unresponsive to available conventional modalities or treatments.
- Have recovered from acute toxicities of prior treatment:
- Be in adequate condition as evidenced by the following clinical laboratory values:
- both female and male patients must use adequate methods of contraception.
Key exclusion criteria (13 listed)
- Intolerance to any antineoplastic agents belonging to the taxoid family.
- having failed a docetaxel-containing regimen or Having known non-controllable hypersensitivity to docetaxel or lipid microsphere.
- Active uncontrolled bleeding or bleeding diathesis (e.g., active peptic ulcer disease).
- Unstable or uncontrolled cardiac disease or hypertension.
- With other serious internal diseases, uncontrolled infection or uncontrolled diabetes.
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 |
|---|---|---|
| DT-LMAlso: Docetaxel Lipid MicrosphereIntravenous infusion, Upto 6 dose levels have been studied i.e. 45, 60, 75, 90 105,and 120 mg/m2, Every 3 weeks. | Drug | DT-LM |
| docetaxelAlso: TaxotereIntravenous infusion, 3 dose levels：60, 75, and 90 mg/m2, Every 3 weeks | Drug | Taxotere |
Primary outcome
The safety and tolerability
Time frame: one year
This Phase I, open-label, control,dose-escalation study was designed to determine the maximum tolerated dose (MTD) of DT-LM in patients with advanced cancer. DT-LM was administered by intravenous infusion, over 1 hour, once every 21 days until occurrence of disease progression or toxicity requiring early treatment discontinuation. Dose escalation was not done until the safety and tolerability at a given dose level has been confirmed.
2 secondary outcomes
Assessment of pharmacokinetics of DT-LM and Taxotere: AUC and Cmax
Time frame: one year
Objective tumour response according to RECIST
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2014.
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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.
Yuankai Shi contact
Xing Tang, Ph.D study director
Shenyang Pharmaceutical University
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 DT-LM and docetaxel in people with Advanced Cancer, run by Shenyang Pharmaceutical University at 1 site in China.
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 16 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: status not confirmed, as of the sponsor's last update on 30 Sep 2014. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuankai Shi (86-10-87788121), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The safety and tolerability (time frame: one year). 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 30 Sep 2014.