Recurrent GliomasPhase 1NCT01445119
A Phase I Trial of Enzastaurin (LY317615) in Combination With Carboplatin in Adults With Recurrent Gliomas
A Phase 1 study testing Enzastaurin (LY317615) and Carboplatin in people with Recurrent Gliomas, run by Eli Lilly and Company at 1 site in United States.
Trial summary
This study will evaluate the safety and effectiveness of Enzastaurin, an experimental drug that may prevent the growth of tumor vessels, in combination with Carboplatin, for patients who have a glioma, a type of brain tumor. Carboplatin is used for treating many kinds of cancers, though not recurrent gliomas. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Gliomas
- What is being tested?
- Enzastaurin (LY317615) and Carboplatin
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Jul 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
None listed.
Who cannot join
- Patients who, in the view of the treating physician, have significant active cardiac, hepatic, or renal diseases are ineligible.
- No concurrent use of other standard chemotherapeutics or investigative agents.
- Prior treatment with platinum-based therapy.
- Patients known to have an allergic response to mannitol.
- Patients known to have an active malignancy other than their malignant glioma (except non-melanoma skin cancer or carcinoma in-situ of the cervix).
- Patients who have an active infection requiring IV antibiotics.
Show all 12Show fewer
- Patients who are pregnant or breast feeding.
- Patients who have any disease that will obscure toxicity or dangerously alter drug metabolism.
- QTc with Bazett's correction that is unmeasurable, or greater than or equal to 460 msec on screening ECG. If a patient has QTc greater than or equal to 460 msec on screening ECG, a second screen ECG may be repeated at least 24 hours apart. The average QTc from the 2 screening ECGs must be less than 460 msec in order for the patient to be eligible for the study.
- EKG demonstrating clinically significant arrythmia (multifocal premature ventricular contraction [PVC], bigeminy, trigeminy, ventricular tachycardia, bradycardia) that is symptomatic or requires treatment (CTCAE Grade 3), or asymptomatic sustained ventricular tachycardia.
- Patients who have baseline EKGs suggestive of past or present cardiac ischemia will not be eligible unless they have an appropriate (as defined by the P.I. of this trial) negative cardiac work up (that is, echocardiogram, stress test).
- Patients may not be on systemic anti-coagulants (that is, heparin, warfarin, small heparin fragments).
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
This study will evaluate the safety and effectiveness of Enzastaurin, an experimental drug that may prevent the growth of tumor vessels, in combination with Carboplatin, for patients who have a glioma, a type of brain tumor. Carboplatin is used for treating many kinds of cancers, though not recurrent gliomas. Tumor growth involves new cancer cell formation and accumulation, requiring a blood supply. Research shows that brain tumor cells can produce substances that stimulate new blood vessel formation. This study will look into whether the combination of drugs can stop that process.
Patients ages 18 and older who have recurring gliomas, who are not pregnant or breast feeding, and who do not have serious diseases may be eligible for this study. About 96 patients will participate for 1 year. They will have a physical examination, give blood and urine samples for analysis, and undergo magnetic resonance imaging (MRI) or computed tomography (CT) scans regarding tumor growth, and perhaps an electrocardiogram. Patients may also undergo a dynamic MRI with spectroscopy or PET scan (positron emission tomography), to distinguish a live tumor from a dying one. Researchers are studying patients taking a certain type of antiseizure medicine and patients who are not taking it because some antiseizure medicines may change the way the body handles a drug such as Enzastaurin. There will be two groups of participants, with 16 to 48 each. Group A is not taking enzyme-inducing antiseizure drugs, and Group B is taking such drugs. In Groups A and B are four dose levels, with 4 to12 patients at each level. Patients' doctors will tell them which group they belong to and how much Enzastaurin and Carboplatin they will take. Treatment consists of Enzastaurin every day for 5 weeks in Cycle 1 only and for 4 weeks beginning with Cycle 2 (each 4-week period as a cycle). Patients take Enzastaurin within 30 minutes after a meal. History, physical, and neurological examinations are repeated at the end of Cycle 1 and then every 4 weeks. Patients will have a repeat head MRI or CT scan before each cycle. If they tolerate the drugs without serious side effects and the tumor is not growing, they may continue with another cycle of Enzastaurin, taking the tablets every day, and Carboplatin being infused on Day 8 of Cycle 1 and on Day 1 of each additional cycle. Routine lab tests are done regularly. Patients will continue the 4-week cycles of treatment for as long as they have no serious side effects and there are no signs of tumor growth. Side effects of Enzastaurin may be fatigue, constipation, cough, and nausea. In men, there may be a decrease in sperm count. Carboplatin can lead to low counts in blood cells and platelets, and there may also be an allergic reaction. Vomiting is a likely side effect. At injection sites, there may be redness, swelling, and pain.
This study may or may not have a direct benefit for participants. However, information gained may help the sponsor of the study, Eli Lilly and Company, and may help patients in the future who have gliomas.
Read the detailed description
Background:
- Enzastaurin, is a macrocyclic bisindolylmaleimide which disrupts the intrinsic phosphotransferase activity of conventional and novel PKC isoforms via an interaction at the ATP binding site, displays selectivity in inhibiting the isoforms. Preclinical studies demonstrate potent anti-angiogenic activity of enzastaurin and studies in normal volunteers and solid tumor patients demonstrate the drug is very well tolerated at doses that achieve a biologically active serum concentration.
- Carboplatin has shown activity as monotherapy in the treatment of recurrent malignant gliomas in adults and preclinical data generated in our laboratory demonstrates additive anti-glioma activity with enzastaurin. The safety profile of carboplatin and the preclinical and clinical data supports its use in combination with enzastaurin in patients with malignant gliomas.
Objective:
-To establish the maximally tolerated dose of enzastaurin in combination with carboplatin in patients with refractory primary brain tumors not on any enzyme-inducing anti-epileptic drugs (nEIAED) and for patients on EIAEDs.
Eligibility:
-Patients with histologically proven malignant glioma are eligible for this study.
Design:
-Patients will be stratified into two groups based on their anti-epileptic medications (nEIAEDs = Group A, EIAED = Group B)
Group A: Each cycle of therapy will consist of enzastaurin administered daily for 4 weeks with no breaks between cycles. All patients will receive a 7-day lead-in treatment period (Cycle 1) consisting of a loading dose of oral enzastaurin on Day 1 at 1125mg, followed by enzastaurin administered once daily at 500mg for 6 additional days in order to achieve steady state pharmacokinetics of enzastaurin. The first dose of carboplatin will be administered on Day 8 of Cycle 1, which will consist of 35 days. Following the lead-in treatment period, the first combination cycle of enzastaurin and carboplatin (Cycle 2) will commence as a 28-day cycle. Within each combination cycle, enzastaurin will be orally administered at 500mg once daily on Days 1 through 28 and carboplatin will be administered as an intravenous infusion over approximately 30 minutes on Day 1 every 28 days. The carboplatin dose will be 3 AUC for dose level one. For dose levels 2, 3, and 4, the carboplatin dose will be 4, 5 and 6 AUC, respectively.
Group B: Each cycle of therapy will consist of enzastaurin administered daily for 4 weeks with no breaks between cycles. All patients will receive a 7-day lead-in treatment period (Cycle 1) consisting of a loading dose of oral enzastaurin on Day 1 at 1125mg, followed by enzastaurin administered once daily at 875mg for 6 additional days in order to achieve steady state pharmacokinetics of enzastaurin. The first dose of carboplatin will be administered on Day 8 of Cycle 1, which will consist of 35 days. Following the lead-in treatment period, the first combination cycle of enzastaurin and carboplatin (Cycle 2) will commence as a 28-day cycle. Within each combination cycle, enzastaurin will be orally administered once daily on Days 1 through 28 at 875mg and carboplatin will be administered as an intravenous infusion over approximately 30 minutes on Day 1 every 28 days. The carboplatin dose will be 3 AUC for dose level one. For dose levels 2, 3, and 4, the carboplatin dose will be 4, 5 and 6 AUC, respectively.
National Cancer Institute (NCI) registered this trial with Eli Lilly as sponsor. NCI did not update the record. In June 2013, NCI transferred the trial to Lilly's clinicaltrials.gov account and Lilly updated the record with the trial status, study start date, and completion dates. This trial is not an applicable trial under Food and Drug Administration Amendments Act of 2007 (FDAAA).
- Conditions
- Recurrent Gliomas
- Being tested
- Enzastaurin (LY317615), Carboplatin
- Keywords
- Brain, Tumor, Radiation, Antiangiogenesis, Chemotherapy, Brain Tumor, Glioma
- Medical subject headings
- Glioma, Neoplasms, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enzastaurin (LY317615)Drug
CarboplatinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To establish the maximally tolerated dose of enzastaurin in combination with carboplatin in patients with refractory primary brain tumors not on any enzyme-inducing anti-epileptic drugs (EIAED) and for patients on EIAEDs.
Secondary outcomes (1)
To obtain exploratory data regarding the relationship between clinical outcome and GSK3-b activation in peripheral blood mononuclear cells in treated patients.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2011 (estimated)
- Study startJan 2007
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Recurrent GliomasStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe 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
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Joohee Sul, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01445119
- Sponsor's protocol ID
- 070053
- Other IDs
- 07-C-0053
- Status last verified
- Aug 2013
- First submitted
- 30 Sep 2011
- Last updated
- 28 Aug 2013
- Results posted
- No
Publications
Soffietti R, Nobile M, Ruda R, Borgognone M, Costanza A, Laguzzi E, Mutani R. Second-line treatment with carboplatin for recurrent or progressive oligodendroglial tumors after PCV (procarbazine, lomustine, and vincristine) chemotherapy: a phase II study. Cancer. 2004 Feb 15;100(4):807-13. doi: 10.1002/cncr.20042.
PubMed 14770438Prados MD, Schold SC Jr, Fine HA, Jaeckle K, Hochberg F, Mechtler L, Fetell MR, Phuphanich S, Feun L, Janus TJ, Ford K, Graney W. A randomized, double-blind, placebo-controlled, phase 2 study of RMP-7 in combination with carboplatin administered intravenously for the treatment of recurrent malignant glioma. Neuro Oncol. 2003 Apr;5(2):96-103. doi: 10.1093/neuonc/5.2.96.
PubMed 12672281Prados MD, Warnick RE, Mack EE, Chandler KL, Rabbitt J, Page M, Malec M. Intravenous carboplatin for recurrent gliomas. A dose-escalating phase II trial. Am J Clin Oncol. 1996 Dec;19(6):609-12. doi: 10.1097/00000421-199612000-00016.
PubMed 8931682
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial of Enzastaurin (LY317615) in Combination With Carboplatin in Adults With Recurrent Gliomas
- ClinicalTrials.gov ID
- NCT01445119
- Acronym / sponsor ID
- 070053
- Conditions
- Recurrent Gliomas
- Keywords
- Brain, Tumor, Radiation, Antiangiogenesis, Chemotherapy, Brain Tumor, Glioma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2007
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 3 Oct 2011 (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 effectiveness of Enzastaurin, an experimental drug that may prevent the growth of tumor vessels, in combination with Carboplatin, for patients who have a glioma, a type of brain tumor. Carboplatin is used for treating many kinds of cancers, though not recurrent gliomas. Tumor growth involves new cancer cell formation and accumulation, requiring a blood supply. Research shows that brain tumor cells can produce substances that stimulate new blood vessel formation. This study will look into whether the combination of drugs can stop that process.
Patients ages 18 and older who have recurring gliomas, who are not pregnant or breast feeding, and who do not have serious diseases may be eligible for this study. About 96 patients will participate for 1 year. They will have a physical examination, give blood and urine samples for analysis, and undergo magnetic resonance imaging (MRI) or computed tomography (CT) scans regarding tumor growth, and perhaps an electrocardiogram. Patients may also undergo a dynamic MRI with spectroscopy or PET scan (positron emission tomography), to distinguish a live tumor from a dying one. Researchers are studying patients taking a certain type of antiseizure medicine and patients who are not taking it because some antiseizure medicines may change the way the body handles a drug such as Enzastaurin. There will be two groups of participants, with 16 to 48 each. Group A is not taking enzyme-inducing antiseizure drugs, and Group B is taking such drugs. In Groups A and B are four dose levels, with 4 to12 patients at each level. Patients' doctors will tell them which group they belong to and how much Enzastaurin and Carboplatin they will take. Treatment consists of Enzastaurin every day for 5 weeks in Cycle 1 only and for 4 weeks beginning with Cycle 2 (each 4-week period as a cycle). Patients take Enzastaurin within 30 minutes after a meal. History, physical, and neurological examinations are repeated at the end of Cycle 1 and then every 4 weeks. Patients will have a repeat head MRI or CT scan before each cycle. If they tolerate the drugs without serious side effects and the tumor is not growing, they may continue with another cycle of Enzastaurin, taking the tablets every day, and Carboplatin being infused on Day 8 of Cycle 1 and on Day 1 of each additional cycle. Routine lab tests are done regularly. Patients will continue the 4-week cycles of treatment for as long as they have no serious side effects and there are no signs of tumor growth. Side effects of Enzastaurin may be fatigue, constipation, cough, and nausea. In men, there may be a decrease in sperm count. Carboplatin can lead to low counts in blood cells and platelets, and there may also be an allergic reaction. Vomiting is a likely side effect. At injection sites, there may be redness, swelling, and pain.
This study may or may not have a direct benefit for participants. However, information gained may help the sponsor of the study, Eli Lilly and Company, and may help patients in the future who have gliomas.
Detailed description
Background:
- Enzastaurin, is a macrocyclic bisindolylmaleimide which disrupts the intrinsic phosphotransferase activity of conventional and novel PKC isoforms via an interaction at the ATP binding site, displays selectivity in inhibiting the isoforms. Preclinical studies demonstrate potent anti-angiogenic activity of enzastaurin and studies in normal volunteers and solid tumor patients demonstrate the drug is very well tolerated at doses that achieve a biologically active serum concentration.
- Carboplatin has shown activity as monotherapy in the treatment of recurrent malignant gliomas in adults and preclinical data generated in our laboratory demonstrates additive anti-glioma activity with enzastaurin. The safety profile of carboplatin and the preclinical and clinical data supports its use in combination with enzastaurin in patients with malignant gliomas.
Objective:
-To establish the maximally tolerated dose of enzastaurin in combination with carboplatin in patients with refractory primary brain tumors not on any enzyme-inducing anti-epileptic drugs (nEIAED) and for patients on EIAEDs.
Eligibility:
-Patients with histologically proven malignant glioma are eligible for this study.
Design:
-Patients will be stratified into two groups based on their anti-epileptic medications (nEIAEDs = Group A, EIAED = Group B)
Group A: Each cycle of therapy will consist of enzastaurin administered daily for 4 weeks with no breaks between cycles. All patients will receive a 7-day lead-in treatment period (Cycle 1) consisting of a loading dose of oral enzastaurin on Day 1 at 1125mg, followed by enzastaurin administered once daily at 500mg for 6 additional days in order to achieve steady state pharmacokinetics of enzastaurin. The first dose of carboplatin will be administered on Day 8 of Cycle 1, which will consist of 35 days. Following the lead-in treatment period, the first combination cycle of enzastaurin and carboplatin (Cycle 2) will commence as a 28-day cycle. Within each combination cycle, enzastaurin will be orally administered at 500mg once daily on Days 1 through 28 and carboplatin will be administered as an intravenous infusion over approximately 30 minutes on Day 1 every 28 days. The carboplatin dose will be 3 AUC for dose level one. For dose levels 2, 3, and 4, the carboplatin dose will be 4, 5 and 6 AUC, respectively.
Group B: Each cycle of therapy will consist of enzastaurin administered daily for 4 weeks with no breaks between cycles. All patients will receive a 7-day lead-in treatment period (Cycle 1) consisting of a loading dose of oral enzastaurin on Day 1 at 1125mg, followed by enzastaurin administered once daily at 875mg for 6 additional days in order to achieve steady state pharmacokinetics of enzastaurin. The first dose of carboplatin will be administered on Day 8 of Cycle 1, which will consist of 35 days. Following the lead-in treatment period, the first combination cycle of enzastaurin and carboplatin (Cycle 2) will commence as a 28-day cycle. Within each combination cycle, enzastaurin will be orally administered once daily on Days 1 through 28 at 875mg and carboplatin will be administered as an intravenous infusion over approximately 30 minutes on Day 1 every 28 days. The carboplatin dose will be 3 AUC for dose level one. For dose levels 2, 3, and 4, the carboplatin dose will be 4, 5 and 6 AUC, respectively.
National Cancer Institute (NCI) registered this trial with Eli Lilly as sponsor. NCI did not update the record. In June 2013, NCI transferred the trial to Lilly's clinicaltrials.gov account and Lilly updated the record with the trial status, study start date, and completion dates. This trial is not an applicable trial under Food and Drug Administration Amendments Act of 2007 (FDAAA).
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (12 listed)
- Patients who, in the view of the treating physician, have significant active cardiac, hepatic, or renal diseases are ineligible.
- No concurrent use of other standard chemotherapeutics or investigative agents.
- Prior treatment with platinum-based therapy.
- Patients known to have an allergic response to mannitol.
- Patients known to have an active malignancy other than their malignant glioma (except non-melanoma skin cancer or carcinoma in-situ of the cervix).
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 |
|---|---|---|
| Enzastaurin (LY317615) | Drug | – |
| Carboplatin | Drug | – |
Primary outcome
To establish the maximally tolerated dose of enzastaurin in combination with carboplatin in patients with refractory primary brain tumors not on any enzyme-inducing anti-epileptic drugs (EIAED) and for patients on EIAEDs.
1 secondary outcome
To obtain exploratory data regarding the relationship between clinical outcome and GSK3-b activation in peripheral blood mononuclear cells in treated patients.
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 28 Aug 2013.
- Background: PubMed 14770438Soffietti R, Nobile M, Ruda R, Borgognone M, Costanza A, Laguzzi E, Mutani R. Second-line treatment with carboplatin for recurrent or progressive oligodendroglial tumors after PCV (procarbazine, lomustine, and vincristine) chemotherapy: a phase II study. Cancer. 2004 Feb 15;100(4):807-13. doi: 10.1002/cncr.20042.
- Background: PubMed 12672281Prados MD, Schold SC Jr, Fine HA, Jaeckle K, Hochberg F, Mechtler L, Fetell MR, Phuphanich S, Feun L, Janus TJ, Ford K, Graney W. A randomized, double-blind, placebo-controlled, phase 2 study of RMP-7 in combination with carboplatin administered intravenously for the treatment of recurrent malignant glioma. Neuro Oncol. 2003 Apr;5(2):96-103. doi: 10.1093/neuonc/5.2.96.
- Background: PubMed 8931682Prados MD, Warnick RE, Mack EE, Chandler KL, Rabbitt J, Page M, Malec M. Intravenous carboplatin for recurrent gliomas. A dose-escalating phase II trial. Am J Clin Oncol. 1996 Dec;19(6):609-12. doi: 10.1097/00000421-199612000-00016.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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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.
Joohee Sul, M.D. principal investigator
National Cancer Institute (NCI)
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 Enzastaurin (LY317615) and Carboplatin in people with Recurrent Gliomas, run by Eli Lilly and Company 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 0 inclusion and 12 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 28 Aug 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 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?
To establish the maximally tolerated dose of enzastaurin in combination with carboplatin in patients with refractory primary brain tumors not on any enzyme-inducing anti-epileptic drugs (EIAED) and for patients on EIAEDs.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01445119, which also lists 3 linked publications.
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 28 Aug 2013.