NeoplasmsPhase 1NCT00532090
A Multiple Ascending Dose Study of R4733 in Patients With Advanced Solid Tumors.
A Phase 1 study testing RG4733 in people with Neoplasms, run by Hoffmann-La Roche at 7 sites in United States.
Trial summary
This study will determine the maximum tolerated dose, safety and pharmacokinetic profile of R4733 (RO4929097), administered orally to patients with refractory metastatic or locally advanced 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?
- RG4733
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 7 sitesUnited States
- Study dates
- Nov 2007to Aug 2010
- 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;
- advanced and/or metastatic solid tumor malignancy;
- measurable or evaluable disease;
- ECOG performance status 0 or 1.
Who cannot join
- prior chemotherapy, radiotherapy or immunotherapy within 28 days of first receipt of study drug;
- prior corticosteroids as anti-cancer therapy within a minimum of 14 days of first receipt of study drug. Dexamethasone may be allowed only as part of the supportive care measures;
- major surgery within 28 days of first receipt of study drug.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Study site
Aurora, Colorado, 80045
Study site
Boston, Massachusetts, 02114
Study site
Boston, Massachusetts, 02115
Study site
Boston, Massachusetts, 02215
Study site
Houston, Texas, 77030
Study site
New Brunswick, New Jersey, 08901
Study site
San Antonio, Texas, 98229
About this study
Official title: Multiple Ascending Dose (MAD) Study of R4733 Administered Orally in Patients With Refractory Metastatic or Locally Advanced Solid Tumors
This study will determine the maximum tolerated dose, safety and pharmacokinetic profile of R4733 (RO4929097), administered orally to patients with refractory metastatic or locally advanced solid tumors. The study will assess three different dosing schedules; in one schedule R4733 will be administered 3days on/ 4 days off, in another on days 1-7 of each 21 day cycle, and in a third schedule continuously daily. The starting dose for each dosing regimen will be escalated in subsequent groups of patients after a satisfactory assessment of the safety and tolerability of the previous dose. The anticipated time on study treatment is until disease progression or dose-limiting toxicity, and the target sample size is 100-200 individuals.
- Conditions
- Neoplasms
- Being tested
- RG4733
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RG4733Drug
Also called RO4929097
Administered orally daily at ascending doses to successive cohorts of patients
RG4733Drug
Also called RO4929097
Administered orally at ascending doses to successive cohorts of patients, on a 3 days on/ 4 days off schedule
RG4733Drug
Also called RO4929097
Administered orally at ascending doses to successive cohorts of patients, on days 1-7 of each 21 day cycle
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: RG4733 |
| 2 | Experimental | Not described Receives: Drug: RG4733 |
| 3 | Experimental | Not described Receives: Drug: RG4733 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AEs, laboratory parameters.
Measured: Throughout study
Secondary outcomes (2)
Tumor assessments
Measured: day 15 cycle 1, at the end of cycle 2 and every 6 weeks thereafter
Pharmacokinetic profile
Measured: After first dose and last dose (or day 15) of cycles 1 and 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2007 (estimated)
- Study startNov 2007
- Primary completionAug 2010
- Study completionAug 2010
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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 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
- NCT00532090
- Sponsor's protocol ID
- NO21321
- Status last verified
- Nov 2016
- First submitted
- 18 Sep 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
- Multiple Ascending Dose (MAD) Study of R4733 Administered Orally in Patients With Refractory Metastatic or Locally Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT00532090
- Acronym / sponsor ID
- NO21321
- Conditions
- Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 19 Sep 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, safety and pharmacokinetic profile of R4733 (RO4929097), administered orally to patients with refractory metastatic or locally advanced solid tumors. The study will assess three different dosing schedules; in one schedule R4733 will be administered 3days on/ 4 days off, in another on days 1-7 of each 21 day cycle, and in a third schedule continuously daily. The starting dose for each dosing regimen will be escalated in subsequent groups of patients after a satisfactory assessment of the safety and tolerability of the previous dose. The anticipated time on study treatment is until disease progression or dose-limiting toxicity, and the target sample size is 100-200 individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: RG4733 |
| 2 | Experimental | Drug: RG4733 |
| 3 | Experimental | Drug: RG4733 |
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;
- advanced and/or metastatic solid tumor malignancy;
- measurable or evaluable disease;
- ECOG performance status 0 or 1.
Key exclusion criteria (3 listed)
- prior chemotherapy, radiotherapy or immunotherapy within 28 days of first receipt of study drug;
- prior corticosteroids as anti-cancer therapy within a minimum of 14 days of first receipt of study drug. Dexamethasone may be allowed only as part of the supportive care measures;
- major surgery within 28 days of first receipt of study drug.
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 |
|---|---|---|
| RG4733Also: RO4929097Administered orally daily at ascending doses to successive cohorts of patients | Drug | 3 |
| RG4733Also: RO4929097Administered orally at ascending doses to successive cohorts of patients, on a 3 days on/ 4 days off schedule | Drug | 1 |
| RG4733Also: RO4929097Administered orally at ascending doses to successive cohorts of patients, on days 1-7 of each 21 day cycle | Drug | 2 |
Primary outcome
AEs, laboratory parameters.
Time frame: Throughout study
2 secondary outcomes
Tumor assessments
Time frame: day 15 cycle 1, at the end of cycle 2 and every 6 weeks thereafter
Pharmacokinetic profile
Time frame: After first dose and last dose (or day 15) of cycles 1 and 2
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
7 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 RG4733 in people with Neoplasms, run by Hoffmann-La Roche at 7 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 3 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 7 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?
AEs, laboratory parameters. (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.