Metastases, NeoplasmPhase 1NCT01115751
A Study in Patients With Advanced or Metastatic Cancer
A Phase 1 study testing LY2780301 in people with Metastases, Neoplasm, run by Eli Lilly and Company at 2 sites in Spain.
Trial summary
Study JWAA is a multicenter, nonrandomized, open-label, dose-escalation Phase 1 study of oral LY2780301 in patients with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastases, Neoplasm
- What is being tested?
- LY2780301
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesSpain
- Study dates
- Mar 2010to Jul 2012
- 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
- Have histological or cytological evidence of a diagnosis of cancer that is advanced and/or metastatic (including Non-Hodgkin's Lymphoma). The patient must be, in the judgment of the investigator, an appropriate candidate for experimental therapy after available standard therapies have failed to provide clinical benefit for their disease.
- Have the presence of measurable or nonmeasurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) or the Revised Response Criteria for Malignant Lymphoma.
- Parts A and B: have measurable or nonmeasurable disease. Part C: have measurable disease.
- Have adequate organ function, including:
- Hematologic: Absolute neutrophil count (ANC) greater than or equal to 1.5 x 109/L, platelets greater than or equal to 100 x 109/L, and hemoglobin greater than or equal to 8 g/dL. Transfusions are not allowed to reach 8 g/dL prior to enrollment.
- Hepatic: Bilirubin less than or equal to 1.5 times upper limits of normal (ULN), alanine aminotransaminase (ALT), and aspartate aminotransaminase (AST) less than or equal to 2.5 times ULN. If the liver has tumor involvement, AST and ALT equaling less than or equal to 5 times ULN are acceptable.
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- Renal: Serum creatinine less than or equal to 1.5 times ULN or calculated creatinine clearance greater than 45 ml/mn.
- Have a performance status of less than or equal to 1 on the Eastern Cooperative Oncology Group (ECOG) scale.
- Have discontinued previous treatments for cancer and recovered from the acute effects of therapy: at least 28 days for myelosuppressive agents or 14 days for nonmyelosuppressive agents. At the discretion of the investigator, hormone-refractory prostate cancer patients who are stable on gonadotropin-releasing hormone (GnRH) agonist therapy may have that treatment continued while they are enrolled in this study.
Who cannot join
- Have received treatment within 28 days of the initial dose of study drug with an experimental agent for noncancer indications that has not received regulatory approval for any indication.
- Have serious preexisting medical conditions (left to the discretion of the investigator).
- Have symptomatic central nervous system (CNS) malignancy or metastasis (screening not required). Patients with treated CNS metastases are eligible for this study if they are not currently receiving corticosteroids and/or anticonvulsants, and their disease is asymptomatic and radiographically stable for at least 60 days.
- Have current acute or chronic leukemia.
- Have an active fungal, bacterial, and/or known viral infection including human immunodeficiency virus (HIV) or viral (A, B, or C) hepatitis (screening is not required).
- Have a second primary malignancy that in the judgment of the investigator and sponsor may affect the interpretation of results.
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- Have QTc interval of >470 msec on screening electrocardiogram(ECG).
- Treatment with a strong CYP3A4 substrate with narrow therapeutic range, strong inhibitor, or inducer.
- Have history of pituitary adenoma.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Barcelona
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Madrid
About this study
Official title: A Phase I Trial of Single-Agent LY2780301 in Patients With Advanced or Metastatic Cancer
Study JWAA is a multicenter, nonrandomized, open-label, dose-escalation Phase 1 study of oral LY2780301 in patients with advanced solid tumors.
Read the detailed description
JWAA will consist of the following treatment phases parts:
Part A - Dose escalation phase using a once-daily dosing schedule. Part B - Dose escalation phase using a twice-daily dosing schedule. Part C - Dose expansion phase using the maximum tolerated dose from either Part A or Part B.
- Conditions
- Metastases, Neoplasm
- Being tested
- LY2780301
- Keywords
- Advanced Cancer, Metastatic Cancer, Solid Tumors
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY2780301Drug
Administered orally, daily for two 28-day cycles.
Starting dose is 100mg. The dose will be subsequently increased to 200mg, 300mg, 400mg, 500mg, and 600mg if no dose limiting toxicity is observed at the prior dose levels. Patients who, in the opinion of the investigator, demonstrate clinical benefit may receive treatment beyond two cycles until disease progression.
| Study group | Role | What they receive |
|---|---|---|
| LY2780301 | Experimental | Part A: daily dosing
Part B (if determined as needed by pharmacokinetic, pharmacodynamic, and safety data): twice daily dosing
Part C: Dose and frequency as determined by Parts A and B of the study. Receives: Drug: LY2780301 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recommended dose for Phase 2 Studies
Measured: Baseline to study completion
Secondary outcomes (6)
Clinically significant effects
Measured: Baseline to study completion
Pharmacokinetics, area under the concentration-time curve
Measured: Baseline, Days 1, 2, 8, 15, and 22 of Cycle 1, Day 1 of Cycle 2
Best overall response (CR+PR+SD)
Measured: Baseline to measured disease progression. Tumor assessments are performed every 2 cycles until disease progression and during post-study follow-up period.
Progression-free survival
Measured: Baseline to measured disease progression or death. Tumor assessments are performed every 2 cycles until disease progression and during post-study follow-up period.
Duration of response
Measured: Time of response to disease progression or death. Tumor assessments are performed every 2 cycles until disease progression and during post-study follow-up period.
Pharmacokinetics, maximum concentration (Cmax)
Measured: Baseline, Days 1, 2, 8, 15, and 22 of Cycle 1, Day 1 of Cycle 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2010 (estimated)
- Study startMar 2010
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastases, NeoplasmStudies 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM - 5PM Eastern Time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01115751
- Sponsor's protocol ID
- 13127
- Other IDs
- I4H-MC-JWAA
- Status last verified
- Jul 2012
- First submitted
- 22 Apr 2010
- Last updated
- 31 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial of Single-Agent LY2780301 in Patients With Advanced or Metastatic Cancer
- ClinicalTrials.gov ID
- NCT01115751
- Acronym / sponsor ID
- 13127
- Conditions
- Metastases, Neoplasm
- Keywords
- Advanced Cancer, Metastatic Cancer, Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 4 May 2010 (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.
Study JWAA is a multicenter, nonrandomized, open-label, dose-escalation Phase 1 study of oral LY2780301 in patients with advanced solid tumors.
Detailed description
JWAA will consist of the following treatment phases parts:
Part A - Dose escalation phase using a once-daily dosing schedule. Part B - Dose escalation phase using a twice-daily dosing schedule. Part C - Dose expansion phase using the maximum tolerated dose from either Part A or Part B.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LY2780301 | Experimental | Drug: LY2780301Part A: daily dosing Part B (if determined as needed by pharmacokinetic, pharmacodynamic, and safety data): twice daily dosing Part C: Dose and frequency as determined by Parts A and B of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Have histological or cytological evidence of a diagnosis of cancer that is advanced and/or metastatic (including Non-Hodgkin's Lymphoma). The patient must be, in the judgment of the investigator, an appropriate candidate for experimental therapy after available standard therapies have failed to provide clinical benefit for their disease.
- Have the presence of measurable or nonmeasurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) or the Revised Response Criteria for Malignant Lymphoma.
- Parts A and B: have measurable or nonmeasurable disease. Part C: have measurable disease.
- Have adequate organ function, including:
- Have a performance status of less than or equal to 1 on the Eastern Cooperative Oncology Group (ECOG) scale.
Key exclusion criteria (9 listed)
- Have received treatment within 28 days of the initial dose of study drug with an experimental agent for noncancer indications that has not received regulatory approval for any indication.
- Have serious preexisting medical conditions (left to the discretion of the investigator).
- Have symptomatic central nervous system (CNS) malignancy or metastasis (screening not required). Patients with treated CNS metastases are eligible for this study if they are not currently receiving corticosteroids and/or anticonvulsants, and their disease is asymptomatic and radiographically stable for at least 60 days.
- Have current acute or chronic leukemia.
- Have an active fungal, bacterial, and/or known viral infection including human immunodeficiency virus (HIV) or viral (A, B, or C) hepatitis (screening is not required).
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 |
|---|---|---|
| LY2780301Administered orally, daily for two 28-day cycles. Starting dose is 100mg. The dose will be subsequently increased to 200mg, 300mg, 400mg, 500mg, and 600mg if no dose limiting toxicity is observed at the prior dose levels. Patients who, in the opinion of the investigator, demonstrate clinical benefit may receive treatment beyond two cycles until disease progression. | Drug | LY2780301 |
Primary outcome
Recommended dose for Phase 2 Studies
Time frame: Baseline to study completion
6 secondary outcomes
Clinically significant effects
Time frame: Baseline to study completion
Pharmacokinetics, area under the concentration-time curve
Time frame: Baseline, Days 1, 2, 8, 15, and 22 of Cycle 1, Day 1 of Cycle 2
Best overall response (CR+PR+SD)
Time frame: Baseline to measured disease progression. Tumor assessments are performed every 2 cycles until disease progression and during post-study follow-up period.
Progression-free survival
Time frame: Baseline to measured disease progression or death. Tumor assessments are performed every 2 cycles until disease progression and during post-study follow-up period.
Duration of response
Time frame: Time of response to disease progression or death. Tumor assessments are performed every 2 cycles until disease progression and during post-study follow-up period.
Pharmacokinetics, maximum concentration (Cmax)
Time frame: Baseline, Days 1, 2, 8, 15, and 22 of Cycle 1, Day 1 of Cycle 2
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 31 Jul 2012.
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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.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM - 5PM Eastern Time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LY2780301 in people with Metastases, Neoplasm, run by Eli Lilly and Company at 2 sites in Spain.
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 9 inclusion and 9 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 31 Jul 2012. 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 Spain. 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?
Recommended dose for Phase 2 Studies (time frame: Baseline to study completion). 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 31 Jul 2012.