NeoplasmsPhase 1NCT00817518
A Dose-Escalating Study of RO4987655 in Patients With Advanced Solid Tumors
A Phase 1 study testing RO4987655 in people with Neoplasms, run by Hoffmann-La Roche at 12 sites in 5 countries.
Trial summary
This study will determine the maximum tolerated dose and the dose-limiting toxicities of RO4987655 in patients with advanced and/or metastatic solid tumors. In the first part of the study, groups of patients will be sequentially enrolled to receive ascending oral doses of RO4987655 daily for 28 days. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- RO4987655
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 12 sitesin 5 countries
- Study dates
- Jan 2009to 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 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 cancer not amenable to standard therapy;
- any solid tumor type (Part 1); malignant melanoma or other responsive tumor type (Part 2);
- measurable and/or evaluable disease (Part 1); >=1 measurable lesion (Part 2);
- ECOG performance status 0-2.
Who cannot join
- prior chemotherapy, radiotherapy or immunotherapy within 28 days of first receipt of study drug;
- prior corticosteroids as anti-cancer therapy within 14 days of first receipt of study drug;
- active CNS lesions;
- acute or chronic infection.
Trial locations and contacts
12 sites in 5 countries.
12 sites in 5 countries
France4 sites
Study site
Marseille, 13385
Study site
Paris, 75231
Study site
Paris, 75651
Study site
Villejuif, 94805
Spain3 sites
Study site
Barcelona, Barcelona, 08003
Study site
Madrid, Madrid, 28050
Study site
Seville, Sevilla, 41013
United Kingdom3 sites
Study site
Cambridge, CB2 2QQ
Study site
London, SW3 6JJ
Study site
Oxford, OX3 7LJ
About this study
Official title: An Open-label, Dose-escalation Study With Extension to Evaluate Safety, Pharmacokinetics and Anti-tumor Activity of RO4987655, a MEK Inhibitor, Administered Orally as Monotherapy in Patients With Advanced Tumors
This study will determine the maximum tolerated dose and the dose-limiting toxicities of RO4987655 in patients with advanced and/or metastatic solid tumors. In the first part of the study, groups of patients will be sequentially enrolled to receive ascending oral doses of RO4987655 daily for 28 days. The starting dose of 1mg daily will be escalated in subsequent groups of patients after a successful assessment of the safety and tolerability of the previous dose. In Part 2 of the study, patients with metastatic or advanced malignant melanoma, or any other responsive tumor type, will be randomized to receive either the maximum tolerated dose or the optimal biological dose of RO4987655 daily. The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.
- Conditions
- Neoplasms
- Being tested
- RO4987655
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RO4987655Drug
Administered po daily for 28 days, at escalating doses, with a starting dose of 1mg (Part 1) maximum tolerated dose administered po daily until disease progression(Part 2)
RO4987655Drug
Administered po daily for 28 days, at escalating doses , with a starting dose of 1mg (Part 1). Optimal biological dose administered po daily until disease progression (Part 2)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: RO4987655 |
| 2 | Experimental | Not described Receives: Drug: RO4987655 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (Part 1)
Measured: Reviewed after each 4 week cycle
Tumor assessments (Part 2)
Measured: Every 8 weeks
Secondary outcomes (1)
Adverse events, laboratory parameters, PD parameters, optimal biological dose (Parts 1 and 2)
Measured: Reviewed after each 4 week cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionDec 2014
- Study completionDec 2014
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
- 145 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
- NCT00817518
- Sponsor's protocol ID
- BO21189
- Other IDs
- 2007-002021-77
- Status last verified
- Sep 2015
- First submitted
- 16 Dec 2008
- Last updated
- 2 Sep 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Dose-escalation Study With Extension to Evaluate Safety, Pharmacokinetics and Anti-tumor Activity of RO4987655, a MEK Inhibitor, Administered Orally as Monotherapy in Patients With Advanced Tumors
- ClinicalTrials.gov ID
- NCT00817518
- Acronym / sponsor ID
- BO21189
- Conditions
- Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 6 Jan 2009 (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 the dose-limiting toxicities of RO4987655 in patients with advanced and/or metastatic solid tumors. In the first part of the study, groups of patients will be sequentially enrolled to receive ascending oral doses of RO4987655 daily for 28 days. The starting dose of 1mg daily will be escalated in subsequent groups of patients after a successful assessment of the safety and tolerability of the previous dose. In Part 2 of the study, patients with metastatic or advanced malignant melanoma, or any other responsive tumor type, will be randomized to receive either the maximum tolerated dose or the optimal biological dose of RO4987655 daily. 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
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: RO4987655 |
| 2 | Experimental | Drug: RO4987655 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- adult patients, >=18 years of age;
- advanced and/or metastatic cancer not amenable to standard therapy;
- any solid tumor type (Part 1); malignant melanoma or other responsive tumor type (Part 2);
- measurable and/or evaluable disease (Part 1); >=1 measurable lesion (Part 2);
- ECOG performance status 0-2.
Key exclusion criteria (4 listed)
- prior chemotherapy, radiotherapy or immunotherapy within 28 days of first receipt of study drug;
- prior corticosteroids as anti-cancer therapy within 14 days of first receipt of study drug;
- active CNS lesions;
- acute or chronic infection.
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 |
|---|---|---|
| RO4987655Administered po daily for 28 days, at escalating doses, with a starting dose of 1mg (Part 1) maximum tolerated dose administered po daily until disease progression(Part 2) | Drug | 1 |
| RO4987655Administered po daily for 28 days, at escalating doses , with a starting dose of 1mg (Part 1). Optimal biological dose administered po daily until disease progression (Part 2) | Drug | 2 |
Primary outcome
Maximum tolerated dose (Part 1)
Time frame: Reviewed after each 4 week cycle
Tumor assessments (Part 2)
Time frame: Every 8 weeks
1 secondary outcome
Adverse events, laboratory parameters, PD parameters, optimal biological dose (Parts 1 and 2)
Time frame: Reviewed after each 4 week cycle
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 Sep 2015.
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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
12 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RO4987655 in people with Neoplasms, run by Hoffmann-La Roche at 12 sites in 5 countries.
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 5 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 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in France, Spain, United Kingdom, Germany, Netherlands. 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 (Part 1) (time frame: Reviewed after each 4 week cycle). 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 2 Sep 2015.