NeoplasmsPhase 1NCT00493155
A Multiple Ascending Dose Study of R1530 in Patients With Advanced Solid Tumors.
A Phase 1 study testing RG1530 in people with Neoplasms, run by Hoffmann-La Roche at 6 sites in United States.
Trial summary
This study will determine the maximum tolerated dose, and assess the safety, tolerability and pharmacokinetics of R1530 administered orally to patients with advanced or metastatic solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- RG1530
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 6 sitesUnited States
- Study dates
- Oct 2005to Feb 2009
- 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
- adult patients, >=18 years of age;
- cancer not amenable to curative treatment (ie advanced and/or metastatic);
- measurable or evaluable disease;
- adequate cardiac, hepatic and renal function.
Who cannot join
- patients with known CNS metastases;
- serious cardiovascular illness or other medical conditions;
- prior chemotherapy, radiotherapy or immunotherapy within 28 days of start of treatment , or hormone therapy within 14 days of start of treatment;
- inability to swallow oral medications, or impaired gastrointestinal absorption.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Study site
Boston, Massachusetts, 02114-2696
Study site
Boston, Massachusetts, 02115
Study site
Boston, Massachusetts, 02215
Study site
Detroit, Michigan, 48201
Study site
Houston, Texas, 77030
Study site
Las Vegas, Nevada, 89135
About this study
Official title: "An Open-label, Multiple Ascending Dose Study to Determine the Maximum Tolerated Dose of R1530 in Patients With Advanced Solid Tumors."
This study will determine the maximum tolerated dose, and assess the safety, tolerability and pharmacokinetics of R1530 administered orally to patients with advanced or metastatic solid tumors. R1530 will be administered daily for 14 days at the starting dose; this dose will be escalated in subsequent cohorts of patients, after a satisfactory assessment of safety and tolerability of the previous dose, until the maximum tolerated dose is reached. The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.
- Conditions
- Neoplasms
- Being tested
- RG1530
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RG1530Drug
Administered po at escalating doses (10 cohorts)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: RG1530 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose
Measured: Throughout study
Secondary outcomes (3)
AEs, laboratory parameters
Measured: Throughout study
Plasma levels of R1530
Measured: Throughout study
Tumor assessments
Measured: Every 2 cycles of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2007 (estimated)
- Study startOct 2005
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00493155
- Sponsor's protocol ID
- NO18674
- Status last verified
- Nov 2016
- First submitted
- 27 Jun 2007
- Last updated
- 2 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "An Open-label, Multiple Ascending Dose Study to Determine the Maximum Tolerated Dose of R1530 in Patients With Advanced Solid Tumors."
- ClinicalTrials.gov ID
- NCT00493155
- Acronym / sponsor ID
- NO18674
- Conditions
- Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Oct 2005
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 28 Jun 2007 (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 study will determine the maximum tolerated dose, and assess the safety, tolerability and pharmacokinetics of R1530 administered orally to patients with advanced or metastatic solid tumors. R1530 will be administered daily for 14 days at the starting dose; this dose will be escalated in subsequent cohorts of patients, after a satisfactory assessment of safety and tolerability of the previous dose, until the maximum tolerated dose is reached. The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: RG1530 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- adult patients, >=18 years of age;
- cancer not amenable to curative treatment (ie advanced and/or metastatic);
- measurable or evaluable disease;
- adequate cardiac, hepatic and renal function.
Key exclusion criteria (4 listed)
- patients with known CNS metastases;
- serious cardiovascular illness or other medical conditions;
- prior chemotherapy, radiotherapy or immunotherapy within 28 days of start of treatment , or hormone therapy within 14 days of start of treatment;
- inability to swallow oral medications, or impaired gastrointestinal absorption.
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 |
|---|---|---|
| RG1530Administered po at escalating doses (10 cohorts) | Drug | 1 |
Primary outcome
Maximum tolerated dose
Time frame: Throughout study
3 secondary outcomes
AEs, laboratory parameters
Time frame: Throughout study
Plasma levels of R1530
Time frame: Throughout study
Tumor assessments
Time frame: Every 2 cycles of treatment
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 2 Nov 2016.
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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.
Clinical Trials study director
Hoffmann-La Roche
6 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 RG1530 in people with Neoplasms, run by Hoffmann-La Roche at 6 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 4 inclusion and 4 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 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
Maximum tolerated dose (time frame: Throughout study). 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 2 Nov 2016.