Sarcoma, Soft TissuePhase 1/2NCT00289809
TLC D-99 and Ifosfamide in Metastatic Soft Tissue Sarcoma Patients
A Phase 1/2 study testing combination of TLC D-99 and Ifosfamide in people with Sarcoma, Soft Tissue, run by Istituto Clinico Humanitas at 1 site in Italy.
Trial summary
The purpose of this study is to determine the maximum tolerated dose of the TLC D-99 combined with ifosfamide and then the efficacy of this combination in terms of overall response rate, time to progression and time of response Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoma, Soft Tissue
- What is being tested?
- combination of TLC D-99 and Ifosfamide
- How many people
- 36 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2006to Dec 2009
- Phase
- Phase 1/2
- 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
- Histologic diagnosis of soft tissue sarcoma metastatic or recurrent after 6 months from the last chemotherapy
- Age >/=18 yrs
- PS </=2
- Disease detectable almost for 1 dimension
- Life expectancy >/=3 mos
- Minimum 4 wks from last radiotherapy
Show all 9Show fewer
- Adequate medullary, liver, and renal functions
- Normal LVEF
- Written Informed Consent
Who cannot join
- Pregnant or breast-feeding patients
- Serious concomitant disease or not controlled infections
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Perspective Phase I and II Trial of Liposome-encapsulated Doxorubicin (TLC D-99) in Combination With Ifosfamide in Patients With Metastatic Soft Tissue Sarcoma
The purpose of this study is to determine the maximum tolerated dose of the TLC D-99 combined with ifosfamide and then the efficacy of this combination in terms of overall response rate, time to progression and time of response
Read the detailed description
The Maximum Tolerated Dose of the combination was determined and the Phase I terminated.
Then, Phase II study started.
- Conditions
- Sarcoma, Soft Tissue
- Being tested
- combination of TLC D-99 and Ifosfamide
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
combination of TLC D-99 and IfosfamideDrug
- TLC D-99: 40 mg/m2 Day 1 every 3 weeks;
- Ifosfamide: 3000 mg/m2 Day 1, 2, 3 every 3 weeks
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I: Maximum Tolerated Dose (MTD) of combination of TLC D-99 and Ifosfamide
Measured: Definition of TDL
Phase II: Response rate (CR/PR or SD)
Measured: Tumor assessment
Secondary outcomes (1)
Phase II: time to progression, duration of response, overall survival
Measured: Tumor assessment, follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2006 (estimated)
- Study startSep 2006
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sarcoma, Soft TissueStudies of the same condition, open and under way.
- More trials run by Istituto Clinico HumanitasThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Investigators
- Armando Santoro, MD, Principal investigator, Istituto Clinico Humanitas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00289809
- Sponsor's protocol ID
- ONC-2005-001
- Other IDs
- EUDRACT 2005-004569-40
- Status last verified
- Dec 2009
- First submitted
- 9 Feb 2006
- Last updated
- 18 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Perspective Phase I and II Trial of Liposome-encapsulated Doxorubicin (TLC D-99) in Combination With Ifosfamide in Patients With Metastatic Soft Tissue Sarcoma
- ClinicalTrials.gov ID
- NCT00289809
- Acronym / sponsor ID
- ONC-2005-001
- Conditions
- Sarcoma, Soft Tissue
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 10 Feb 2006 (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 determine the maximum tolerated dose of the TLC D-99 combined with ifosfamide and then the efficacy of this combination in terms of overall response rate, time to progression and time of response
Detailed description
The Maximum Tolerated Dose of the combination was determined and the Phase I terminated.
Then, Phase II study started.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologic diagnosis of soft tissue sarcoma metastatic or recurrent after 6 months from the last chemotherapy
- Age >/=18 yrs
- PS </=2
- Disease detectable almost for 1 dimension
- Life expectancy >/=3 mos
Key exclusion criteria (2 listed)
- Pregnant or breast-feeding patients
- Serious concomitant disease or not controlled infections
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 |
|---|---|---|
| combination of TLC D-99 and Ifosfamide* TLC D-99: 40 mg/m2 Day 1 every 3 weeks; * Ifosfamide: 3000 mg/m2 Day 1, 2, 3 every 3 weeks | Drug | – |
Primary outcome
Phase I: Maximum Tolerated Dose (MTD) of combination of TLC D-99 and Ifosfamide
Time frame: Definition of TDL
Phase II: Response rate (CR/PR or SD)
Time frame: Tumor assessment
1 secondary outcome
Phase II: time to progression, duration of response, overall survival
Time frame: Tumor assessment, follow-up
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 18 Dec 2009.
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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.
Armando Santoro, MD principal investigator
Istituto Clinico Humanitas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing combination of TLC D-99 and Ifosfamide in people with Sarcoma, Soft Tissue, run by Istituto Clinico Humanitas at 1 site in Italy.
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 9 inclusion and 2 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 18 Dec 2009. 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 Italy. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Phase I: Maximum Tolerated Dose (MTD) of combination of TLC D-99 and Ifosfamide (time frame: Definition of TDL). 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 18 Dec 2009.