Advanced Solid TumorsPhase 1NCT00603356
Phase I Study of OSI-930 and Erlotinib in Cancer Tumors
A Phase 1 study testing OSI-930 and erlotinib in people with Advanced Solid Tumors, run by Astellas Pharma Inc at 2 sites in 2 countries.
Trial summary
This is a Phase I, dose escalation, safety study of OSI-930 and Erlotinib in cancer tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- OSI-930 and erlotinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Nov 2007to Jul 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
- Histology or cytologically documented malignancy that is now advanced and/or metastatic and refractory to established forms of therapy or for which no effective therapy exists
- Age greater than or equal to 18 years
- ECOG PS 0-2
- ANC greater than or equal to 1.5 x 10^9/L
- Bilirubin less than or equal to 1.5 x upper limit of normal (ULN), AST and ALT less than or equal to 2.5 x ULN
- Creatinine less than or equal to 1.5 ULN
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- Predicted life expectancy greater than or equal to 12 weeks
- Prior chemotherapy is permitted provided that a minimum of 3 weeks has elapsed
- Prior tyrosine kinase inhibitor therapy is permitted
- Patients must have recovered from any treatment-related toxicities (with some exceptions) prior to registration
- Prior hormonal therapy is permitted provided it is discontinued prior to registration (with the exception of prostate cancer patients who have been on hormone therapy for at least 3 months)
- Prior radiation therapy is permitted provided that it did not exceed 25% of bone marrow reserve and patients have recovered from the toxic effects (a minimum of 21 days must have elapsed unless the radiotherapy was palliative and nonmyelosuppressive)
- Prior surgery is permitted, provided that wound healing has occurred prior to registration
- Patients must use proactive effective contraceptive measures throughout the study
- Provide written informed consent
- Accessible for repeat dosing and follow-up
- Adequate hematopoietic, hepatic, and renal function
Who cannot join
- Significant cardiac disease unless well controlled
- Current or former smokers, unless patients stopped smoking greater than 3 months prior to registration
- Active or uncontrolled infections of serious illnesses or medical conditions that could interfere with participation
- History of unacceptable toxicity with previous EGFR inhibitor therapy
- History of any psychiatric condition that might impair the patient's ability to provide informed consent or participate
- Use of CYP3A4 inducers/inhibitors during the 14 days prior to first dose
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- Pregnant or breast-feeding females
- Symptomatic brain metastases which are not stable, require steroids, are potentially life-threatening or that have required radiation within the last 28 days
- History of allergic reaction attributed to a similar compound as study drug
- GI abnormalities including inability to take oral medications, required for IV alimentation
- Clinically significant ophthalmologic abnormalities
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
H Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
United Kingdom1 site
The Beatson West of Scotland Cancer Centre
Glasgow, G12 0YN
About this study
Official title: A Phase 1 Dose Escalation Study of Daily Oral OSI-930 and Erlotinib (Tarceva) in Patients With Advanced Solid Tumors
This is a Phase I, dose escalation, safety study of OSI-930 and Erlotinib in cancer tumors.
Read the detailed description
Multicenter, open-label, phase 1, dose escalation study to determine the maximum tolerated dose of OSI-930 and Erlotinib.
Patients may continue to receive OSI-930 and Erlotinib until one of the following occurs: disease progression, adverse event requiring withdrawal, failure to recover from toxicity despite a 14-day dosing interruption, medical or ethical reasons, patient request, or patient death.
- Conditions
- Advanced Solid Tumors
- Being tested
- OSI-930 and erlotinib
- Keywords
- GIST, Ovarian Cancer, Mesothelioma, Renal, Colorectal Cancer, Sarcoma, NSCLC, Cancer
- Medical subject headings
- Ovarian Neoplasms, Mesothelioma, Colorectal Neoplasms, Sarcoma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OSI-930 and erlotinibDrug
OSI-930 administered daily in combination with Erlotinib at increasing doses until disease progression or unacceptable toxicity
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Dose Escalation Receives: Drug: OSI-930 and erlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the maximum tolerated dose (MTD), evaluate the pharmacokinetic profiles
Measured: 18 months
Secondary outcomes (1)
Safety, evaluate pharmacodynamic relationships
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2008 (estimated)
- Study startNov 2007
- Primary completionApr 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- OSI Pharmaceuticals
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00603356
- Sponsor's protocol ID
- OSI-930-103
- Status last verified
- Sep 2011
- First submitted
- 26 Dec 2007
- Last updated
- 27 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Dose Escalation Study of Daily Oral OSI-930 and Erlotinib (Tarceva) in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT00603356
- Acronym / sponsor ID
- OSI-930-103
- Conditions
- Advanced Solid Tumors
- Keywords
- GIST, Ovarian Cancer, Mesothelioma, Renal, Colorectal Cancer, Sarcoma, NSCLC, Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Collaborators
- OSI Pharmaceuticals
- Study start
- Nov 2007
- Primary completion
- Apr 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 29 Jan 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 is a Phase I, dose escalation, safety study of OSI-930 and Erlotinib in cancer tumors.
Detailed description
Multicenter, open-label, phase 1, dose escalation study to determine the maximum tolerated dose of OSI-930 and Erlotinib.
Patients may continue to receive OSI-930 and Erlotinib until one of the following occurs: disease progression, adverse event requiring withdrawal, failure to recover from toxicity despite a 14-day dosing interruption, medical or ethical reasons, patient request, or patient death.
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: OSI-930 and erlotinibDose Escalation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Histology or cytologically documented malignancy that is now advanced and/or metastatic and refractory to established forms of therapy or for which no effective therapy exists
- Age greater than or equal to 18 years
- ECOG PS 0-2
- ANC greater than or equal to 1.5 x 10^9/L
- Bilirubin less than or equal to 1.5 x upper limit of normal (ULN), AST and ALT less than or equal to 2.5 x ULN
Key exclusion criteria (11 listed)
- Significant cardiac disease unless well controlled
- Current or former smokers, unless patients stopped smoking greater than 3 months prior to registration
- Active or uncontrolled infections of serious illnesses or medical conditions that could interfere with participation
- History of unacceptable toxicity with previous EGFR inhibitor therapy
- History of any psychiatric condition that might impair the patient's ability to provide informed consent or participate
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 |
|---|---|---|
| OSI-930 and erlotinibOSI-930 administered daily in combination with Erlotinib at increasing doses until disease progression or unacceptable toxicity | Drug | 1 |
Primary outcome
Determine the maximum tolerated dose (MTD), evaluate the pharmacokinetic profiles
Time frame: 18 months
1 secondary outcome
Safety, evaluate pharmacodynamic relationships
Time frame: 18 months
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 27 Sep 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 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 OSI-930 and erlotinib in people with Advanced Solid Tumors, run by Astellas Pharma Inc at 2 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 17 inclusion and 11 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 27 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, United Kingdom. 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?
Determine the maximum tolerated dose (MTD), evaluate the pharmacokinetic profiles (time frame: 18 months). 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 27 Sep 2011.