AdultPhase 1NCT00052273
LY317615 Plus Capecitabine in Treating Patients With Advanced Solid Tumors
A Phase 1 study testing capecitabine and enzastaurin hydrochloride in people with Adult and Solid Tumor, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial summary
RATIONALE: LY317615 may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth and by stopping blood flow to the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult, Solid Tumor
- What is being tested?
- capecitabine and enzastaurin hydrochloride
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2002to Oct 2005
- 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 confirmed solid tumor that is refractory to standard therapy or for which no standard therapy exists
- Measurable or evaluable disease
- 18 and over
- ECOG 0-2
- Hematopoietic
- Absolute neutrophil count at least 1,500/mm^3
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- Platelet count at least 100,000/mm^3
- Hemoglobin at least 9 g/dL (erythrocyte transfusions allowed)
- Hepatic
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- ALT and AST no greater than 2.5 times ULN (5 times ULN if liver metastases present)
- Renal
- Creatinine clearance at least 50 mL/min
- Potassium at least 3.4 mEq/L
- Calcium at least 8.4 mg/dL
- Magnesium at least 1.2 mEq/L
- Cardiovascular
- QTc interval no greater than 450 msec in males
- QTc interval no greater than 470 msec in females
- No other electrocardiogram abnormalities
- Able to swallow capsules
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3-6 months after study
- Endocrine therapy
- At least 4 weeks since prior anticancer hormonal therapy
- At least 6 weeks since prior bicalutamide
- At least 4 weeks since prior flutamide or nilutamide
- Concurrent luteinizing hormone-releasing hormone analog therapy (e.g., leuprolide or goserelin) allowed for patients with prostate cancer if started before study entry
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin).
- Radiotherapy
- At least 4 weeks since prior radiotherapy
- At least 2 weeks since prior palliative radiotherapy
- Recovered from prior therapy
- Other
- At least 4 weeks since prior investigational anticancer therapy
- At least 4 weeks since other prior anticancer therapy
- At least 30 days since prior experimental drugs
Who cannot join
- known untreated or symptomatic CNS metastases
- concurrent hematologic malignancies
- gastrointestinal disorder that would interfere with oral drug absorption
- serious concurrent systemic disorder
- compliance issues that would preclude study
- geographical conditions that would preclude study
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- active infection
- prior hypersensitivity to any component of study drugs
- pregnant or nursing
- concurrent immunotherapy
- concurrent routine filgrastim (G-CSF)
- other concurrent chemotherapy
- other concurrent hormonal therapy
- concurrent radiotherapy (including palliative therapy)
- other concurrent experimental medications
- other concurrent anticancer therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
About this study
Official title: A Phase I Dose Escalation Study With Oral LY317615 in Combination With Capecitabine in Advanced Cancer Patients
RATIONALE: LY317615 may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth and by stopping blood flow to the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining LY317615 with capecitabine may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combining LY317615 with capecitabine in treating patients who have advanced solid tumors.
Read the detailed description
OBJECTIVES:
- Determine the maximum tolerated dose and the recommended phase II dose of LY317615 and capecitabine in patients with advanced solid tumors.
- Determine the safety profile of this regimen in these patients.
- Determine the pharmacokinetics of this regimen in these patients.
- Determine, preliminarily, the antitumor activity of this regimen in these patients.
- Determine the effects of LY317615 on potential angiogenic surrogate markers in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive oral LY317615 daily on days 1-14 (course 1 only). Beginning with course 2, patients receive oral LY317615 daily on days 1-21 and oral capecitabine twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of LY317615 and capecitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are treated at the recommended phase II dose.
Patients are followed at 30 days after the last dose of study drug.
PROJECTED ACCRUAL: A total of 12-36 patients will be accrued for this study.
- Conditions
- Adult, Solid Tumor
- Being tested
- capecitabine, enzastaurin hydrochloride
- Keywords
- unspecified adult solid tumor, protocol specific
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
capecitabineDrug
enzastaurin hydrochlorideDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startDec 2002
- Primary completionNov 2004
- Study completionOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdultStudies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive Cancer CenterThe 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
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company
- Responsible party
- Sponsor
- Investigators
- Carolyn Britten, MD, Principal investigator, Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00052273
- Sponsor's protocol ID
- CDR0000258138
- Other IDs
- UCLA-0206061, LILLY-H6Q-MC-JCAH, NCI-G02-2132
- Status last verified
- Aug 2012
- First submitted
- 24 Jan 2003
- Last updated
- 3 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Dose Escalation Study With Oral LY317615 in Combination With Capecitabine in Advanced Cancer Patients
- ClinicalTrials.gov ID
- NCT00052273
- Acronym / sponsor ID
- CDR0000258138
- Conditions
- Adult, Solid Tumor
- Keywords
- unspecified adult solid tumor, protocol specific
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Eli Lilly and Company
- Study start
- Dec 2002
- Primary completion
- Nov 2004 (actual)
- Study completion
- Oct 2005 (actual)
- First posted
- 27 Jan 2003 (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.
RATIONALE: LY317615 may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth and by stopping blood flow to the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining LY317615 with capecitabine may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combining LY317615 with capecitabine in treating patients who have advanced solid tumors.
Detailed description
OBJECTIVES:
- Determine the maximum tolerated dose and the recommended phase II dose of LY317615 and capecitabine in patients with advanced solid tumors.
- Determine the safety profile of this regimen in these patients.
- Determine the pharmacokinetics of this regimen in these patients.
- Determine, preliminarily, the antitumor activity of this regimen in these patients.
- Determine the effects of LY317615 on potential angiogenic surrogate markers in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive oral LY317615 daily on days 1-14 (course 1 only). Beginning with course 2, patients receive oral LY317615 daily on days 1-21 and oral capecitabine twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of LY317615 and capecitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are treated at the recommended phase II dose.
Patients are followed at 30 days after the last dose of study drug.
PROJECTED ACCRUAL: A total of 12-36 patients will be accrued for this study.
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 (37 listed)
- Histologically confirmed solid tumor that is refractory to standard therapy or for which no standard therapy exists
- Measurable or evaluable disease
- 18 and over
- ECOG 0-2
- Hematopoietic
Key exclusion criteria (16 listed)
- known untreated or symptomatic CNS metastases
- concurrent hematologic malignancies
- gastrointestinal disorder that would interfere with oral drug absorption
- serious concurrent systemic disorder
- compliance issues that would preclude 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 |
|---|---|---|
| capecitabine | Drug | – |
| enzastaurin hydrochloride | Drug | – |
Primary outcome
Not reported in the source record.
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 3 Aug 2020.
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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.
Carolyn Britten, MD principal investigator
Jonsson Comprehensive Cancer Center
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 capecitabine and enzastaurin hydrochloride in people with Adult and Solid Tumor, run by Jonsson Comprehensive Cancer Center 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 37 inclusion and 16 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 3 Aug 2020. 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.
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 3 Aug 2020.