CancerPhase 1NCT01567384
A Phase I Study of OSI-906 in Combination With Pemetrexed in Advanced Solid Tumor Malignancies
A Phase 1 study testing OSI-906 and Pemetrexed in people with Cancer and Neoplasms, run by Emory University at 1 site in United States.
Trial summary
The purpose of the study is to test the safety of an experimental drug called OSI-906 when combined with pemetrexed at different dose levels and to find out the optimal doses of the two drugs that can be given as a combination. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- OSI-906 and Pemetrexed
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Oct 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
- Both men and women of all races and ethnic groups are eligible for this trial.
- Patients must have histologically confirmed malignancy.
- Patient's tumor type must be appropriate for therapy with pemetrexed or have no standard treatment approaches.
- Patients must have discontinued previous chemotherapy and/or radiation at least 3 weeks[six weeks for nitrosoureas, BCNU, or mitomycin C] prior to entry into the study and recovered from any toxic effects of previous treatment. Pallative radiation therapy to sites involving more than 2 weeks prior to enrollment on this study.
- Age greater than 18 years.
- ECOG performance status less than 2 [see Appendix A].
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- Patients should be able to take oral medications.
- Patients must have normal organ and marrow function as defined below:
- leukocytes greater than 3,000/mcL
- absolute neutrophil count greater than 1,500/mcL
- platelets greater than 100,000/mcL
- total bilirubin within normal institutional limits AST[SGOT]/ALT[SGPT]less than 2.5 x institutional upper limit of normal
- creatinine within normal institutional limits OR
- creatinine clearance greater than 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal.
- The effects of OSI-906 on the developing human fetus are unknown. For this reason and because chemotherapeutic agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception [hormonal or barrier method of birth control; abstinence] prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Patients may not be receiving any other investigational agents.
- Patients with untreated, active or symptomatic brain metastases should be excluded from this clinical trial.
- History of allergic reaction to OSI-906 or pemetrexed.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit adherence with study requirements.
- Pregnant women are excluded from this study because OSI-906 and pemetrexed are anti-proliferative agents agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with OSI-906, breastfeeding should be discontinued if the mother is treated OSI-906. These potential risks may also apply to other agents used in this study.
- HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with OSI-906. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.
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- Patients with QTc interval greater than 450 msec at baseline will be excluded due to risk of QTc prolongation with OSI-906.
- Patients taking medications that prolong the QTc interval will be excluded.
- Patients with significant cardiac disease will be excluded.
- Patients with fasting blood glucose greater than 150 mg/dL at baseline will be excluded due to risk of hyperglycemia with OSI-906.
- Use of drugs that have a known risk of causing Torsades de Pointes [TdP] [Torsades List on www.azcert.org/medical-pros/drug-lists/bycategory.cfm, see Appendix D] are prohibited within 14 days prior to randomization.
- Use of the potent CYP1A2 inhibitors ciprofloxacin and fluvoxamine. Other less potent CYP1A2 inhibitors/inducers are not excluded.
- Patients with a history of poorly controlled gastrointestinal disorders that could affect the absorption of study drug (eg, Crohn's disease, ulcerative colitis, etc) should be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322
About this study
The purpose of the study is to test the safety of an experimental drug called OSI-906 when combined with pemetrexed at different dose levels and to find out the optimal doses of the two drugs that can be given as a combination. Pemetrexed has been widely used for treatment of certain solid organ tumors and is effective and approved for use in treatment of lung cancer and mesothelioma.
Read the detailed description
OSI-906 is a new agent that inhibits the insulin-like growth factor receptor pathway. Targeting this pathway appears to be a promising strategy to treat cancer based on laboratory studies. The present study will test if this agent can be administered safely in combination with pemetrexed, a commonly used chemotherapeutic agent.
- Being tested
- OSI-906 and Pemetrexed
- Keywords
- cancer, neoplasms, tumors
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OSI-906 and PemetrexedDrug
Pemetrexed will be administered intravenously on day 1 of cycle 1 at a dose of 500 mg/m2 as a 10-minute infusion. Subsequent doses will be defined by tolerability.
OSI-906 will be administered orally twice daily (12 hours apart) at approximately the same times each day on a continuous schedule, beginning on Day 0 of cycle 1.
| Study group | Role | What they receive |
|---|---|---|
| Combination therapy with OSI and Pemetrexed | Experimental | Not described Receives: Drug: OSI-906 and Pemetrexed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of dose-limiting toxicity
To define the dose of OSI-906 that can be combined with pemetrexed
Measured: 21 days
Secondary outcomes (1)
Progression-free survival
Response and progression will be evaluated in this study using the new international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) [Eur J Ca 45:228-247, 2009]. Changes in the largest diameter (unidimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes are used in the RECIST criteria.
Measured: 4-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2012 (estimated)
- Study startMay 2012
- Primary completionOct 2013 (estimated)
- Study completionOct 2013 (estimated)
Why it stopped: The sponsor withdrew support for the study before any patients were enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- OSI Pharmaceuticals
- Responsible party
- Principal investigator, Suresh S. Ramalingam, Emory University
- Investigators
- Suresh Ramalingam, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01567384
- Sponsor's protocol ID
- IRB00047570
- Other IDs
- WCI1895-10
- Status last verified
- Nov 2013
- First submitted
- 20 Dec 2011
- Last updated
- 20 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of OSI-906 in Combination With Pemetrexed in Advanced Solid Tumor Malignancies
- ClinicalTrials.gov ID
- NCT01567384
- Acronym / sponsor ID
- IRB00047570
- Keywords
- cancer, neoplasms, tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The sponsor withdrew support for the study before any patients were enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- OSI Pharmaceuticals
- Study start
- May 2012
- Primary completion
- Oct 2013 (estimated)
- Study completion
- Oct 2013 (estimated)
- First posted
- 30 Mar 2012 (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 purpose of the study is to test the safety of an experimental drug called OSI-906 when combined with pemetrexed at different dose levels and to find out the optimal doses of the two drugs that can be given as a combination. Pemetrexed has been widely used for treatment of certain solid organ tumors and is effective and approved for use in treatment of lung cancer and mesothelioma.
Detailed description
OSI-906 is a new agent that inhibits the insulin-like growth factor receptor pathway. Targeting this pathway appears to be a promising strategy to treat cancer based on laboratory studies. The present study will test if this agent can be administered safely in combination with pemetrexed, a commonly used chemotherapeutic agent.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combination therapy with OSI and Pemetrexed | Experimental | Drug: OSI-906 and Pemetrexed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Both men and women of all races and ethnic groups are eligible for this trial.
- Patients must have histologically confirmed malignancy.
- Patient's tumor type must be appropriate for therapy with pemetrexed or have no standard treatment approaches.
- Patients must have discontinued previous chemotherapy and/or radiation at least 3 weeks[six weeks for nitrosoureas, BCNU, or mitomycin C] prior to entry into the study and recovered from any toxic effects of previous treatment. Pallative radiation therapy to sites involving more than 2 weeks prior to enrollment on this study.
- Age greater than 18 years.
Key exclusion criteria (13 listed)
- Patients may not be receiving any other investigational agents.
- Patients with untreated, active or symptomatic brain metastases should be excluded from this clinical trial.
- History of allergic reaction to OSI-906 or pemetrexed.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit adherence with study requirements.
- Pregnant women are excluded from this study because OSI-906 and pemetrexed are anti-proliferative agents agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with OSI-906, breastfeeding should be discontinued if the mother is treated OSI-906. These potential risks may also apply to other agents used in this study.
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-906 and PemetrexedPemetrexed will be administered intravenously on day 1 of cycle 1 at a dose of 500 mg/m2 as a 10-minute infusion. Subsequent doses will be defined by tolerability. OSI-906 will be administered orally twice daily (12 hours apart) at approximately the same times each day on a continuous schedule, beginning on Day 0 of cycle 1. | Drug | Combination therapy with OSI and Pemetrexed |
Primary outcome
Assessment of dose-limiting toxicity
Time frame: 21 days
To define the dose of OSI-906 that can be combined with pemetrexed
1 secondary outcome
Progression-free survival
Time frame: 4-6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 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.
Suresh Ramalingam, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing OSI-906 and Pemetrexed in people with Cancer and Neoplasms, run by Emory University at 1 site 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 16 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: withdrawn, as of the sponsor's last update on 20 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 withdrawn before enrolling participants, so there are no results.
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?
Assessment of dose-limiting toxicity (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 20 Nov 2013.