Any Solid Tumor or LymphomaPhase 1NCT00698243
Study of Oral OSI-027 in Patients With Advanced Solid Tumors or Lymphoma
A Phase 1 study testing OSI-027 in people with Any Solid Tumor or Lymphoma, run by Astellas Pharma Inc at 3 sites in 3 countries.
Trial summary
The primary objective of this study is to determine the maximum tolerated dose (MTD) and to establish the recommended phase 2 dose of oral OSI-027 when administered via 3 schedules, namely, intermittent, weekly, and continuous in patients with advanced solid tumors or lymphoma, namely, intermittent, weekly, and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Any Solid Tumor or Lymphoma
- What is being tested?
- OSI-027
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Jun 2008to Feb 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
- Histologically or cytologically documented malignancy (solid tumor or lymphoma)
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤ 2
- Predicted life expectancy of at least 3 months
- Adequate hematopoietic and hepatic function, and normal renal function
- Fasting glucose <7mmol/L at baseline
- Left ventricular ejection fracture (LVEF) by Multiple gated acquisition scan (MUGA)≥ 60%
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- Practice effective contraceptive measures throughout study
- Verbal and written informed consent
- Prior therapy:
- Chemotherapy, minimum of 3 weeks and recovered from any treatment-related toxicities (except for alopecia, and grade 1 neurotoxicity) prior to registration
- Hormonal, discontinued prior to registration
- Radiation, minimum of 21 days and recovered from toxic effects prior to registration
- Surgery, provided wound healing has occurred
Who cannot join
- History of significant cardiac disease unless well controlled
- Discontinuation from prior therapy due to cardiac toxicity
- Active or uncontrolled infections
- Serious illness or medical condition that could interfere with study participation
- History of any psychiatric condition that might impair understanding or compliance
- Documented history of diabetes mellitus
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- Pregnant or breastfeeding females
- Unstable symptomatic brain metastases, that require steroid or that have required radiation in the last 28 days
- Chronic systemic steroid use for cancer related condition
- History of allergic reactions
- Patients with cataract who are expected to undergo surgery within 6 months of registration
- Use of drugs causing QT interval prolongation within 14 days prior to dosing
- Patients with clinically significant electrolyte imbalances
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: A Phase 1 Dose-escalation Study of Intermittent, Once Weekly, and Continuous Daily Oral OSI-027 Dosing in Patients With Advanced Solid Tumors or Lymphoma
The primary objective of this study is to determine the maximum tolerated dose (MTD) and to establish the recommended phase 2 dose of oral OSI-027 when administered via 3 schedules, namely, intermittent, weekly, and continuous in patients with advanced solid tumors or lymphoma, namely, intermittent, weekly, and continuous.
Read the detailed description
The study will open with Schedule 1 (S1, intermittent) with initiation of Schedule 2 (S2, weekly) and Schedule 3 (S3, continuous), which may occur in parallel after observation of clinically significant related dose limiting toxicity (DLT) in the S1 schedule. Dosing will be initiated on Day 1 with intermittent weekly dosing continuing for 21 days (1 Treatment Period). Expansion of Dose Escalation Cohorts may occur for S1 and S2 at the recommended phase 2 dose level(s) and a Biomarker Expansion Cohort may be opened in S1 and/or S2.
- Conditions
- Any Solid Tumor or Lymphoma
- Being tested
- OSI-027
- Keywords
- OSI-027, Solid tumor, Lymphoma
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OSI-027Drug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| Schedule 1 | Experimental | Once daily for 3 days every 7 days Receives: Drug: OSI-027 |
| Schedule 2 | Experimental | Once weekly Receives: Drug: OSI-027 |
| Schedule 3 | Experimental | Once daily Receives: Drug: OSI-027 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose
Measured: 21 days
Secondary outcomes (4)
Safety profile of OSI-027
Measured: up to 5 years
Pharmacokinetic profile of OSI-027
Measured: up to 23 days
Preliminary pharmacodynamic relationship with OSI-027 systemic exposure
Measured: up to 23 days
Preliminary antitumor activity of OSI-027
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Any Solid Tumor or LymphomaStudies 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
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Astellas Pharma Global Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00698243
- Sponsor's protocol ID
- OSI-027-101
- Other IDs
- 2007-006158-25
- Status last verified
- Apr 2013
- First submitted
- 13 Jun 2008
- Last updated
- 15 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Dose-escalation Study of Intermittent, Once Weekly, and Continuous Daily Oral OSI-027 Dosing in Patients With Advanced Solid Tumors or Lymphoma
- ClinicalTrials.gov ID
- NCT00698243
- Acronym / sponsor ID
- OSI-027-101
- Conditions
- Any Solid Tumor or Lymphoma
- Keywords
- OSI-027, Solid tumor, Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 17 Jun 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.
The primary objective of this study is to determine the maximum tolerated dose (MTD) and to establish the recommended phase 2 dose of oral OSI-027 when administered via 3 schedules, namely, intermittent, weekly, and continuous in patients with advanced solid tumors or lymphoma, namely, intermittent, weekly, and continuous.
Detailed description
The study will open with Schedule 1 (S1, intermittent) with initiation of Schedule 2 (S2, weekly) and Schedule 3 (S3, continuous), which may occur in parallel after observation of clinically significant related dose limiting toxicity (DLT) in the S1 schedule. Dosing will be initiated on Day 1 with intermittent weekly dosing continuing for 21 days (1 Treatment Period). Expansion of Dose Escalation Cohorts may occur for S1 and S2 at the recommended phase 2 dose level(s) and a Biomarker Expansion Cohort may be opened in S1 and/or S2.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Schedule 1 | Experimental | Drug: OSI-027Once daily for 3 days every 7 days |
| Schedule 2 | Experimental | Drug: OSI-027Once weekly |
| Schedule 3 | Experimental | Drug: OSI-027Once daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Histologically or cytologically documented malignancy (solid tumor or lymphoma)
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤ 2
- Predicted life expectancy of at least 3 months
- Adequate hematopoietic and hepatic function, and normal renal function
- Fasting glucose <7mmol/L at baseline
Key exclusion criteria (13 listed)
- History of significant cardiac disease unless well controlled
- Discontinuation from prior therapy due to cardiac toxicity
- Active or uncontrolled infections
- Serious illness or medical condition that could interfere with study participation
- History of any psychiatric condition that might impair understanding or compliance
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-027Administered orally | Drug | Schedule 1, Schedule 2, Schedule 3 |
Primary outcome
Maximum tolerated dose
Time frame: 21 days
4 secondary outcomes
Safety profile of OSI-027
Time frame: up to 5 years
Pharmacokinetic profile of OSI-027
Time frame: up to 23 days
Preliminary pharmacodynamic relationship with OSI-027 systemic exposure
Time frame: up to 23 days
Preliminary antitumor activity of OSI-027
Time frame: up to 5 years
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 15 Apr 2013.
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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.
Medical Monitor study director
Astellas Pharma Global Development
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing OSI-027 in people with Any Solid Tumor or Lymphoma, run by Astellas Pharma Inc at 3 sites in 3 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 13 inclusion and 13 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 15 Apr 2013. 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, Belgium, 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?
Maximum tolerated dose (time frame: 21 days). 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 15 Apr 2013.