NeoplasmsPhase 1NCT00811993
A Study of R1507 in Combination With Multiple Standard Chemotherapy Treatments in Patients With Advanced Solid Tumors
A Phase 1 study testing RG1507, RO1507 and bevacizumab [Avastin] in people with Neoplasms, run by Hoffmann-La Roche at 8 sites in United States.
Trial summary
This study will evaluate the safety and tolerability of R1507 in combination with 12 distinct standard chemotherapy drug regimens and an additional R1507 monotherapy arm in patients with advanced malignant neoplasms.The 12 regimens will be tested in parallel. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- RG1507, RO1507 and bevacizumab [Avastin]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 8 sitesUnited States
- Study dates
- Feb 2009to Dec 2012
- 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;
- malignant neoplasms;
- failed prior standard curative therapy;
- ECOG performance Status of 0 or 1;
- adequate bone marrow, hepatic and renal function;
- life expectancy greater than 8 weeks.
Who cannot join
- chemotherapy within 2 weeks of start of therapy;
- prior irradiation within 4 weeks prior to start of therapy;
- prior treatment with agents targeting IGF-IR inhibition, or other investigational agents;
- major surgery or significant traumatic injury within 2 weeks prior to study start;
- patients receiving concurrent antibody or immunotherapy;
- other exclusion criteria are related to specific treatment regimens.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Study site
Chapel Hill, North Carolina, 27514
Study site
Chicago, Illinois, 60637
Study site
Houston, Texas, 77030
Study site
Rochester, Minnesota, 55905
Study site
San Francisco, California, 94115
Study site
Santa Monica, California, 90025
Study site
Tucson, Arizona, 85724
Study site
Washington D.C., District of Columbia, 20007
About this study
Official title: Phase Ib Study To Evaluate The Safety Of Combining IGF-1R Antagonist R1507 With Multiple Standard Chemotherapy Drug Treatments In Patients With Advanced Malignancies
This study will evaluate the safety and tolerability of R1507 in combination with 12 distinct standard chemotherapy drug regimens and an additional R1507 monotherapy arm in patients with advanced malignant neoplasms.The 12 regimens will be tested in parallel. There are 3 subsets of patients who are eligible for the study: untreated, treated and requiring further treatment, or treated and failed and for whom adding R1507 represents a suitable treatment for their disease. All regimens will first test doses of R1507 which are less than the maximally administered dose, and if tolerated, the dose will be escalated in subsequent patients. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.
- Conditions
- Neoplasms
- Being tested
- RG1507, RO1507, bevacizumab [Avastin], capecitabine [Xeloda], carboplatin
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RG1507Drug
Starting dose of >=3mg/kg iv escalating to a maximum dose of <=16mg/kg iv, depending on dosing schedule in each combination treatment arm
RO1507Drug
27mg/kg iv, monotherapy
bevacizumab [Avastin]Drug
as prescribed
capecitabine [Xeloda]Drug
as prescribed
carboplatinDrug
as prescribed
cetuximabDrug
as prescribed
docetaxelDrug
as prescribed
erlotinib [Tarceva]Drug
as prescribed
etoposideDrug
as prescribed
gemcitabineDrug
as prescribed
irinotecanDrug
as prescribed
mFOLFOX6Drug
as prescribed
paclitaxelDrug
as prescribed
pemetrexelDrug
as prescribed
sorafenibDrug
as prescribed
temozolomideDrug
as prescribed
trastuzumab [Herceptin]Drug
as prescribed
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: RG1507; Drug: erlotinib [Tarceva]; Drug: gemcitabine |
| 10 | Experimental | Not described Receives: Drug: RG1507; Drug: temozolomide |
| 11 | Experimental | Not described Receives: Drug: RG1507; Drug: bevacizumab [Avastin]; Drug: docetaxel |
| 12 | Experimental | Not described Receives: Drug: RG1507; Drug: pemetrexel |
| 13 | Experimental | Not described Receives: Drug: RO1507 |
| 2 | Experimental | Not described Receives: Drug: RG1507; Drug: bevacizumab [Avastin]; Drug: paclitaxel |
| 3 | Experimental | Not described Receives: Drug: RG1507; Drug: carboplatin; Drug: etoposide |
| 4 | Experimental | Not described Receives: Drug: RG1507; Drug: bevacizumab [Avastin]; Drug: mFOLFOX6 |
| 5 | Experimental | Not described Receives: Drug: RG1507; Drug: capecitabine [Xeloda]; Drug: trastuzumab [Herceptin] |
| 6 | Experimental | Not described Receives: Drug: RG1507; Drug: sorafenib |
| 7 | Experimental | Not described Receives: Drug: RG1507; Drug: bevacizumab [Avastin]; Drug: erlotinib [Tarceva] |
| 8 | Experimental | Not described Receives: Drug: RG1507; Drug: cetuximab; Drug: irinotecan |
| 9 | Experimental | Not described Receives: Drug: RG1507; Drug: bevacizumab [Avastin]; Drug: carboplatin; Drug: paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events, laboratory parameters, vital signs
Measured: Throughout study
Secondary outcomes (1)
Trough levels of R1507
Measured: Throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2008 (estimated)
- Study startFeb 2009
- Primary completionDec 2012
- Study completionDec 2012
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
- 104 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
- NCT00811993
- Sponsor's protocol ID
- NO22068
- Status last verified
- Nov 2016
- First submitted
- 18 Dec 2008
- 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
- Phase Ib Study To Evaluate The Safety Of Combining IGF-1R Antagonist R1507 With Multiple Standard Chemotherapy Drug Treatments In Patients With Advanced Malignancies
- ClinicalTrials.gov ID
- NCT00811993
- Acronym / sponsor ID
- NO22068
- Conditions
- Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 19 Dec 2008 (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 evaluate the safety and tolerability of R1507 in combination with 12 distinct standard chemotherapy drug regimens and an additional R1507 monotherapy arm in patients with advanced malignant neoplasms.The 12 regimens will be tested in parallel. There are 3 subsets of patients who are eligible for the study: untreated, treated and requiring further treatment, or treated and failed and for whom adding R1507 represents a suitable treatment for their disease. All regimens will first test doses of R1507 which are less than the maximally administered dose, and if tolerated, the dose will be escalated in subsequent patients. 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
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 13
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: RG1507, Drug: erlotinib [Tarceva], Drug: gemcitabine |
| 10 | Experimental | Drug: RG1507, Drug: temozolomide |
| 11 | Experimental | Drug: RG1507, Drug: bevacizumab [Avastin], Drug: docetaxel |
| 12 | Experimental | Drug: RG1507, Drug: pemetrexel |
| 13 | Experimental | Drug: RO1507 |
| 2 | Experimental | Drug: RG1507, Drug: bevacizumab [Avastin], Drug: paclitaxel |
| 3 | Experimental | Drug: RG1507, Drug: carboplatin, Drug: etoposide |
| 4 | Experimental | Drug: RG1507, Drug: bevacizumab [Avastin], Drug: mFOLFOX6 |
| 5 | Experimental | Drug: RG1507, Drug: capecitabine [Xeloda], Drug: trastuzumab [Herceptin] |
| 6 | Experimental | Drug: RG1507, Drug: sorafenib |
| 7 | Experimental | Drug: RG1507, Drug: bevacizumab [Avastin], Drug: erlotinib [Tarceva] |
| 8 | Experimental | Drug: RG1507, Drug: cetuximab, Drug: irinotecan |
| 9 | Experimental | Drug: RG1507, Drug: bevacizumab [Avastin], Drug: carboplatin, Drug: paclitaxel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- adult patients, >=18 years of age;
- malignant neoplasms;
- failed prior standard curative therapy;
- ECOG performance Status of 0 or 1;
- adequate bone marrow, hepatic and renal function;
Key exclusion criteria (6 listed)
- chemotherapy within 2 weeks of start of therapy;
- prior irradiation within 4 weeks prior to start of therapy;
- prior treatment with agents targeting IGF-IR inhibition, or other investigational agents;
- major surgery or significant traumatic injury within 2 weeks prior to study start;
- patients receiving concurrent antibody or immunotherapy;
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 |
|---|---|---|
| RG1507Starting dose of >=3mg/kg iv escalating to a maximum dose of <=16mg/kg iv, depending on dosing schedule in each combination treatment arm | Drug | 1, 10, 11, 12, 2, 3, 4, 5, 6, 7, 8, 9 |
| RO150727mg/kg iv, monotherapy | Drug | 13 |
| bevacizumab [Avastin]as prescribed | Drug | 11, 2, 4, 7, 9 |
| capecitabine [Xeloda]as prescribed | Drug | 5 |
| carboplatinas prescribed | Drug | 3, 9 |
| cetuximabas prescribed | Drug | 8 |
| docetaxelas prescribed | Drug | 11 |
| erlotinib [Tarceva]as prescribed | Drug | 1, 7 |
| etoposideas prescribed | Drug | 3 |
| gemcitabineas prescribed | Drug | 1 |
| irinotecanas prescribed | Drug | 8 |
| mFOLFOX6as prescribed | Drug | 4 |
| paclitaxelas prescribed | Drug | 2, 9 |
| pemetrexelas prescribed | Drug | 12 |
| sorafenibas prescribed | Drug | 6 |
| temozolomideas prescribed | Drug | 10 |
| trastuzumab [Herceptin]as prescribed | Drug | 5 |
Primary outcome
Adverse events, laboratory parameters, vital signs
Time frame: Throughout study
1 secondary outcome
Trough levels of R1507
Time frame: 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
8 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 RG1507, RO1507 and bevacizumab [Avastin] in people with Neoplasms, run by Hoffmann-La Roche at 8 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 6 inclusion and 6 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 8 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 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?
Adverse events, laboratory parameters, vital signs (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.