Advanced or Metastatic Solid TumoursPhase 1NCT01281592
A Study of LOR-253 HCl in Patients With Advanced or Metastatic Solid Tumours
A Phase 1 study testing LOR-253 HCl in people with Advanced or Metastatic Solid Tumours, run by Aptose Biosciences Inc. at 2 sites in United States.
Trial summary
This is an open-label, phase 1 study to determine the maximum tolerated dose (MTD) or appropriate target dose if MTD not reached to identify the recommended phase 2 dose of LOR-253 HCl in patients with advanced or metastatic solid tumours. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced or Metastatic Solid Tumours
- What is being tested?
- LOR-253 HCl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2011to Jan 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female 18 years of age or older.
- Histologically confirmed diagnosis of solid tumour for which no effective therapy is available or that is unresponsive to conventional therapy.
- Meet laboratory parameter requirements at study entry.
Who cannot join
- Chemotherapy, radiotherapy, biologic therapy, immunotherapy or any other investigational drugs within 21 days of beginning study treatment with LOR-253 HCl.
- A hematologic malignancy.
- A history of brain or other central nervous system metastases.
- Have a presence of a significant infection.
- Clinically significant autoimmune disease.
- Uncontrolled intercurrent illness.
- With iron or copper overload syndromes.
- Pregnancy or breast feeding.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
MD Anderson Cancer Center
Houston, Texas, 77030
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
About this study
Official title: Open-Label, Phase 1 Study of LOR-253 HCl in Patients With Advanced or Metastatic Solid Tumours
This is an open-label, phase 1 study to determine the maximum tolerated dose (MTD) or appropriate target dose if MTD not reached to identify the recommended phase 2 dose of LOR-253 HCl in patients with advanced or metastatic solid tumours.
- Conditions
- Advanced or Metastatic Solid Tumours
- Being tested
- LOR-253 HCl
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LOR-253 HClDrug
Also called No other names are used.
LOR-253 HCl will be given in ascending doses starting from 20 mg/m2 until the maximum administered dose or appropriate target dose is reached. Patient will be treated on LOR-253 HCl for 2 cycles for the evaluation.
| Study group | Role | What they receive |
|---|---|---|
| LOR-253 HCl | Experimental | LOR-253 HCl will be given in ascending doses until the maximum administered dose or appropriate target dose is reached. A biomarker study of up to 10 patients will be conducted upon achieving appropriate dose level. Receives: Drug: LOR-253 HCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the maximum tolerated dose (MTD) or appropriate target dose if MTD not reached to identify the recommended phase 2 dose of LOR-253 HCl in patients with advanced or metastatic solid tumours.
Measured: 8 weeks
Secondary outcomes (1)
To characterize the safety profile of LOR-253 HCl when administered to patients with advanced or metastatic solid tumours.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionJul 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced or Metastatic Solid TumoursStudies 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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aptose Biosciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrea Cercek, M.D., Principal investigator, Memorial Sloan Kettering Cancer CenterJennifer Wheler, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01281592
- Sponsor's protocol ID
- 253-SOL1-01
- Status last verified
- Feb 2014
- First submitted
- 20 Jan 2011
- Last updated
- 25 Feb 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label, Phase 1 Study of LOR-253 HCl in Patients With Advanced or Metastatic Solid Tumours
- ClinicalTrials.gov ID
- NCT01281592
- Acronym / sponsor ID
- 253-SOL1-01
- Conditions
- Advanced or Metastatic Solid Tumours
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Aptose Biosciences Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 24 Jan 2011 (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 an open-label, phase 1 study to determine the maximum tolerated dose (MTD) or appropriate target dose if MTD not reached to identify the recommended phase 2 dose of LOR-253 HCl in patients with advanced or metastatic solid tumours.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LOR-253 HCl | Experimental | Drug: LOR-253 HClLOR-253 HCl will be given in ascending doses until the maximum administered dose or appropriate target dose is reached. A biomarker study of up to 10 patients will be conducted upon achieving appropriate dose level. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female 18 years of age or older.
- Histologically confirmed diagnosis of solid tumour for which no effective therapy is available or that is unresponsive to conventional therapy.
- Meet laboratory parameter requirements at study entry.
Key exclusion criteria (8 listed)
- Chemotherapy, radiotherapy, biologic therapy, immunotherapy or any other investigational drugs within 21 days of beginning study treatment with LOR-253 HCl.
- A hematologic malignancy.
- A history of brain or other central nervous system metastases.
- Have a presence of a significant infection.
- Clinically significant autoimmune disease.
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 |
|---|---|---|
| LOR-253 HClAlso: No other names are used.LOR-253 HCl will be given in ascending doses starting from 20 mg/m2 until the maximum administered dose or appropriate target dose is reached. Patient will be treated on LOR-253 HCl for 2 cycles for the evaluation. | Drug | LOR-253 HCl |
Primary outcome
To determine the maximum tolerated dose (MTD) or appropriate target dose if MTD not reached to identify the recommended phase 2 dose of LOR-253 HCl in patients with advanced or metastatic solid tumours.
Time frame: 8 weeks
1 secondary outcome
To characterize the safety profile of LOR-253 HCl when administered to patients with advanced or metastatic solid tumours.
Time frame: 8 weeks
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 25 Feb 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.
Andrea Cercek, M.D. principal investigator
Memorial Sloan Kettering Cancer Center
Jennifer Wheler, MD principal investigator
M.D. Anderson Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LOR-253 HCl in people with Advanced or Metastatic Solid Tumours, run by Aptose Biosciences Inc. at 2 sites in United States.
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 3 inclusion and 8 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 25 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
To determine the maximum tolerated dose (MTD) or appropriate target dose if MTD not reached to identify the recommended phase 2 dose of LOR-253 HCl in patients with advanced or metastatic solid tumours. (time frame: 8 weeks). 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 Feb 2014.