NeoplasmsPhase 1NCT00985374
A Multiple Ascending Dose Study of the mTOR Inhibitor (RAD001) in Combination With R1507 in Patients With Advanced Solid Tumors
A Phase 1 study testing RAD001 and RG1507 in people with Neoplasms, run by Hoffmann-La Roche at 3 sites in 2 countries.
Trial summary
This 2 part study will assess the safety, tolerability and efficacy of a combination of oral daily RAD001 and intravenous 3-weekly R1507 in patients with advanced solid tumors. In Part 1 of the study, patients will be enrolled sequentially to receive 5mg by mouth (po) RAD001 daily + 16mg/kg intravenous (iv) R1507… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- RAD001 and RG1507
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Nov 2009to Jun 2013
- 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;
- histologically confirmed recurrent or refractory advanced solid tumor (Part 1);
- advanced metastatic renal cell cancer OR advanced metastatic pancreatic neuroendocrine tumors, with evidence of progressive disease (Part 2);
- measurable disease (Part 2);
- ECOG performance status 0-2.
Who cannot join
- prior treatment with agents acting via inhibition of IGF-IR pathway;
- prior treatment with agents acting via inhibition of mTOR (Part 2);
- untreated CNS metastases;
- current anti-cancer therapy, or radiotherapy or chemotherapy <=4 weeks prior to enrollment;
- other known malignancy requiring treatment.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Study site
New York, New York, 10017
Study site
San Antonio, Texas, 98229
About this study
Official title: Multiple Ascending Dose (MAD) Phase Ib/II Study of the mTOR Inhibitor (RAD001) in Combination With the IGF-1R Antagonist (R1507) for the Treatment of Patients With Advanced Solid Tumors
This 2 part study will assess the safety, tolerability and efficacy of a combination of oral daily RAD001 and intravenous 3-weekly R1507 in patients with advanced solid tumors. In Part 1 of the study, patients will be enrolled sequentially to receive 5mg by mouth (po) RAD001 daily + 16mg/kg intravenous (iv) R1507 every 3 weeks (level 1) and if tolerated, 10mg po RAD001 daily + 16mg/kg iv R1507 every 3 weeks (level 2).In Part 2 of the study, patients with 1) advanced renal cell cancer and 2) advanced pancreatic neuroendocrine tumors will receive the maximum tolerated dose regimen from Part 1 (5mg or 10mg po RAD001 + 16mg/kg iv R1507). The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.
- Conditions
- Neoplasms
- Being tested
- RAD001, RG1507
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RAD001Drug
5mg or 10mg po daily
RG1507Drug
16mg/kg iv every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: RAD001; Drug: RG1507 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose of RAD001, in combination with R1507 (Part 1
Measured: First 3 week cycle of treatment
Progression-free survival (Part 2)
Measured: 24 weeks
Secondary outcomes (1)
Overall objective response rate; duration of response; overall survival
Measured: Event driven; monitored throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2009 (estimated)
- Study startNov 2009
- Primary completionJun 2013
- Study completionJun 2013
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
- 11 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
- NCT00985374
- Sponsor's protocol ID
- NO21884
- Other IDs
- 2008-005806-38, 2008
- Status last verified
- Nov 2016
- First submitted
- 24 Sep 2009
- 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) Phase Ib/II Study of the mTOR Inhibitor (RAD001) in Combination With the IGF-1R Antagonist (R1507) for the Treatment of Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT00985374
- Acronym / sponsor ID
- NO21884
- Conditions
- Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 28 Sep 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 2 part study will assess the safety, tolerability and efficacy of a combination of oral daily RAD001 and intravenous 3-weekly R1507 in patients with advanced solid tumors. In Part 1 of the study, patients will be enrolled sequentially to receive 5mg by mouth (po) RAD001 daily + 16mg/kg intravenous (iv) R1507 every 3 weeks (level 1) and if tolerated, 10mg po RAD001 daily + 16mg/kg iv R1507 every 3 weeks (level 2).In Part 2 of the study, patients with 1) advanced renal cell cancer and 2) advanced pancreatic neuroendocrine tumors will receive the maximum tolerated dose regimen from Part 1 (5mg or 10mg po RAD001 + 16mg/kg iv R1507). The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 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: RAD001, Drug: RG1507 |
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;
- histologically confirmed recurrent or refractory advanced solid tumor (Part 1);
- advanced metastatic renal cell cancer OR advanced metastatic pancreatic neuroendocrine tumors, with evidence of progressive disease (Part 2);
- measurable disease (Part 2);
- ECOG performance status 0-2.
Key exclusion criteria (5 listed)
- prior treatment with agents acting via inhibition of IGF-IR pathway;
- prior treatment with agents acting via inhibition of mTOR (Part 2);
- untreated CNS metastases;
- current anti-cancer therapy, or radiotherapy or chemotherapy <=4 weeks prior to enrollment;
- other known malignancy requiring treatment.
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 |
|---|---|---|
| RAD0015mg or 10mg po daily | Drug | 1 |
| RG150716mg/kg iv every 3 weeks | Drug | 1 |
Primary outcome
Maximum tolerated dose of RAD001, in combination with R1507 (Part 1
Time frame: First 3 week cycle of treatment
Progression-free survival (Part 2)
Time frame: 24 weeks
1 secondary outcome
Overall objective response rate; duration of response; overall survival
Time frame: Event driven; monitored throughout study
Results and safety
The study was stopped early. Results are not available in the source record.
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
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RAD001 and RG1507 in people with Neoplasms, run by Hoffmann-La Roche at 3 sites in 2 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 5 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: stopped early, 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 3 sites in United States, 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 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 was stopped early. Results are not available in the source record.
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 of RAD001, in combination with R1507 (Part 1 (time frame: First 3 week cycle of treatment). 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 Nov 2016.