Advanced CancerPhase 1NCT01212107
A Phase 1 Study of LY2874455 in Participants With Advanced Cancer
A Phase 1 study testing FGF Receptor and Phosphate Binders in people with Advanced Cancer, run by Eli Lilly and Company at 3 sites in 2 countries.
Trial summary
The study is to determine the recommended Phase 2 regimen of study drug that may be safely administered to participants with advanced and or metastatic cancer. The study consists of two parts: a dose escalation and a dose confirmation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- FGF Receptor and Phosphate Binders
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Dec 2010to Feb 2015
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 (solid tumors, lymphoma, or chronic lymphocytic leukemia) that is advanced and/or metastatic and for which all standard therapies have failed
- Have the presence of measurable or non-measurable disease
- Have given written informed consent prior to any study-specific procedures
- Have adequate organ function including:
- Hematologic: Absolute neutrophil count (ANC) equal to or greater than 1.5 x 10(9)/L platelets equal to or greater than 100 x 10(9)/L, and hemoglobin equal to or greater than 8 g/dL. Participants may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator. Initial treatment must not begin until 14 days after the erythrocyte transfusion
- Hepatic: Bilirubin equal to or less than 1.5 times upper limits of normal (ULN), alanine transaminase (ALT), and aspartate transaminase (AST) equal to or less than 2.5 times ULN. If the liver has tumor involvement, AST and ALT equaling equal to or less than 5 times ULN are acceptable
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- Renal: Serum creatinine less than or equal to 1.2 times ULN or calculated creatinine clearance greater than or equal to 60 milliliters per minute using the Standard Cockcroft and Gault Creatinine Clearance Calculation
- Calcium and phosphate less than or equal to 1.1 times ULN
- Have a performance status of 0, 1, or 2 on the Eastern Cooperative Oncology Group (ECOG) scale
- Have discontinued chemotherapy and cancer-related hormonal therapy with commercially available agents for at least 21 days (6 weeks for mitomycin-C or nitrosoureas) and radiotherapy for at least 14 days prior to study enrollment and recovered from the acute effects of therapy. Hormone refractory prostate cancer participants receiving gonadotropin releasing hormone (GnRH) agonist therapy or breast cancer participants on antiestrogen therapy (for example, an aromatase inhibitor) prior to entrance on the study may have that treatment continued while they are enrolled in the study
- Females with childbearing potential must have had a negative serum pregnancy test less than or equal to 7 days prior to the first dose of study drug. Males and females with reproductive potential must agree to use 2 medically approved contraceptive methods during the trial and for 3 months following the last dose of study drug. Female participants must agree to use 2 medically acceptable methods of contraception, 1 being an oral contraceptive, dermal patch, or progestin (implantation or injection), and the other being a medically acceptable barrier method; alternatively, 2 medically acceptable barrier methods may be used. Medically acceptable barrier methods of contraception that may be used by the participant and/or his/her partner include: abstinence; diaphragm with spermicide; intrauterine device (IUD); condom together with foam, spermicide, or vaginal spermicidal suppository. Prohibited methods include the rhythm method, withdrawal, condoms alone, or diaphragm alone
- Have an estimated life expectancy of greater than or equal to 12 weeks
Who cannot join
- Have received treatment with an investigational drug, which has not received regulatory approval for any indication, within 28 days of study treatment with LY2874455
- Currently taking agents to control serum phosphate or calcium levels. This includes dietary restrictions
- Have medical conditions that, in the opinion of the investigator, would preclude participation in this study
- Have symptomatic central nervous system (CNS) malignancy or metastasis. Participants with treated CNS metastases are eligible provided their disease is radiographically stable, asymptomatic, and they are not currently receiving corticosteroids and/or anticonvulsants. Screening of asymptomatic participants without history of CNS metastases is not required
- Have a history of major organ transplant (for example: heart, lungs, liver, and kidney)
- Have current acute leukemia
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- Females who are pregnant or nursing
- An untreated or uncontrolled acute infection, including urinary tract infection, within 7 days of study entry
- Have Bazett's corrected QT (QTcB) greater than 470 msec (female) or greater than 450 msec (male), history of unexplained recurrent syncope, history of congenital long QT syndrome, family history of sudden death, or the presence in the screening electrocardiogram (ECG) of a conduction abnormality that in the opinion of the investigator would preclude safe participation in this study
- Have had an autologous or allogenic bone marrow transplant
- Previously treated with LY2874455
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Australia2 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 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
East Melbourne, Victoria, 3002
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Parkville, Victoria, 3050
South Korea1 site
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Seoul, 110-744
About this study
Official title: A Phase 1 Study of LY2874455 to Assess Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy in Patients With Advanced Cancer.
The study is to determine the recommended Phase 2 regimen of study drug that may be safely administered to participants with advanced and or metastatic cancer. The study consists of two parts: a dose escalation and a dose confirmation.
Read the detailed description
Phase 1, first human dose study
- Conditions
- Advanced Cancer
- Being tested
- FGF Receptor, Phosphate Binders
- Keywords
- Advanced cancer, Metastatic cancer, Oncology
- Medical subject headings
- Neoplasm Metastasis, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FGF ReceptorDrug
Also called LY2874455
LY2874455 administered orally.
Phosphate BindersDrug
| Study group | Role | What they receive |
|---|---|---|
| Part A: 2 mg FGF Receptor QD | Experimental | Part A: Dose escalation
2 milligrams (mg) FGF receptor given orally once daily (QD) for a minimum of (1) 28 day cycle.
If participants are determined to be receiving benefit, study treatment may be continued for up to one (1) year (12 cycles of 28 days) Receives: Drug: FGF Receptor |
| Part A: 4 mg FGF Receptor QD | Experimental | Part A: Dose escalation
4 mg FGF receptor given orally QD for a minimum of (1) 28 day cycle.
If participants are determined to be receiving benefit, study treatment may be continued for up to one (1) year (12 cycles of 28 days) Receives: Drug: FGF Receptor |
| Part A: 10 mg FGF Receptor QD | Experimental | Part A: Dose escalation
10 mg FGF receptor given orally QD for a minimum of (1) 28 day cycle.
If participants are determined to be receiving benefit, study treatment may be continued for up to one (1) year (12 cycles of 28 days). Receives: Drug: FGF Receptor |
| Part A: 10 mg FGF Receptor QD + Phosphate Binders | Experimental | Part A: Dose escalation
10 mg FGF receptor + phosphate binders given QD for a minimum of (1) 28 day cycle.
If participants are determined to be receiving benefit, study treatment may be continued for up to one (1) year (12 cycles of 28 days) Receives: Drug: FGF Receptor; Drug: Phosphate Binders |
| Part A: 8 mg FGF Receptor BID | Experimental | Part A: Dose escalation
8 mg of FGF receptor given orally twice a day (BID) for a minimum of (1) 28 day cycle.
If participants are determined to be receiving benefit, study treatment may be continued for up to one (1) year (12 cycles of 28 days) Receives: Drug: FGF Receptor |
| Part A: 10 mg FGF Receptor BID | Experimental | Part A: Dose escalation
10 mg FGF receptor given orally BID for a minimum of (1) 28 day cycle.
If participants are determined to be receiving benefit, study treatment may be continued for up to one (1) year (12 cycles of 28 days) Receives: Drug: FGF Receptor |
| Part A: 14 mg FGF Receptor BID | Experimental | Part A: Dose escalation
14 FGF receptor given orally BID for a minimum of (1) 28 day cycle.
If participants are determined to be receiving benefit, study treatment may be continued for up to one (1) year (12 cycles of 28 days) Receives: Drug: FGF Receptor |
| Part A: 18 mg FGF Receptor BID | Experimental | Part A: Dose escalation
18 mg FGF receptor given orally BID for a minimum of (1) 28 day cycle.
If participants are determined to be receiving benefit, study treatment may be continued for up to one (1) year (12 cycles of 28 days) Receives: Drug: FGF Receptor |
| Part A: 24 mg FGF Receptor BID | Experimental | Part A: Dose escalation
24 mg FGF receptor given orally BID for a minimum of (1) 28 day cycle.
If participants are determined to be receiving benefit, study treatment may be continued for up to one (1) year (12 cycles of 28 days). Receives: Drug: FGF Receptor |
| Part A: 18 mg FGF Receptor BID Extension | Experimental | Part A: Dose escalation
18 mg FGF Receptor given orally BID for a minimum of (1) 28 day cycle.
If participants are determined to be receiving benefit, study treatment may be continued for up to one (1) year (12 cycles of 28 days) Receives: Drug: FGF Receptor |
| Part A: 16 mg FGF Receptor BID | Experimental | Part A: Dose escalation
16 mg FGF Receptor given orally BID for a minimum of (1) 28 day cycle.
If participants are determined to be receiving benefit, study treatment may be continued for up to one (1) year (12 cycles of 28 days) Receives: Drug: FGF Receptor |
| Part B: 16 mg FGF Receptor BID | Experimental | Part B: Dose determined by part a dose escalation
16 mg FGF Receptor given orally BID for a minimum of (1) 28 day cycle.
If participants are determined to be receiving benefit, study treatment may be continued for up to one (1) year (12 cycles of 28 days) Receives: Drug: FGF Receptor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recommended Dose for Phase 2 Studies : Maximum Tolerated Dose (MTD)
MTD was determined after the evaluation of Part A portion of the trial. Dose escalation proceeded at 1.3 times the preceding cohort once a Grade 3 non-laboratory toxicity or Grade 2 laboratory toxicity was noted in ≥ 1 participant until MTD was achieved. Doses up to 24 mg (48 mg/day) were evaluated in Part A. The effects at this dose and at 18 mg (36 mg/day) suggested that a reasonable number of participants might not tolerate LY2874455 for chronic administration at these dose levels because of the constellation of effects observed individually or in combination in participants at these dose levels. Therefore, the dose of 16 mg BID of LY2874455 (total dose 32 mg per day) was selected as the initial dose for Part B. Selection of the dose level was based on the tolerability of this dose and without specific toxicities identified.
Measured: Baseline Up to 32 Weeks
Secondary outcomes (4)
Number of Participants With Treatment-Emergent Adverse Events
Treatment-emergent adverse events (TEAEs) are events which were not present at baseline or pre-existing conditions at baseline that worsened in severity following the start of treatment. A summary of other non-serious Adverse Events (AEs), and all Serious Adverse Events (SAE's), regardless of causality, is located in the Reported Adverse Events section.
Measured: Baseline Up to 60 Weeks
Percentage of Participants With Best Overall Response Rate (BORR) and Objective Response Rate (ORR)
BORR is evaluated using response evaluation criteria in solid tumors (RECIST, version 1.1) criteria. Complete Response (CR): disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to <10 millimeters (mm). Partial Response (PR): at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the baseline sum diameter.
Best overall response rate = (unconfirmed CR+ unconfirmed PR) / subjects in efficacy population.
Objective response rate = (confirmed CR+ confirmed PR) / subjects in efficacy population.
Measured: BORR: Baseline Up to 60 Weeks ; ORR: Baseline Up to 60 Weeks
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY2874455
Maximum observed concentration during a dosing interval.
Measured: Part A and B: Cycle 1, Day 1, Pre-Dose, 0.5 Hr (H), 1 H, 2 H, 4H,8 H,12 H,24 H; Day 28, Pre-Dose, 0.5 H, 1 H, 2 H, 4 H, 8 H
Pharmacokinetics (PK): Area Under the Concentration vs Time Curve 0 to Tau ( AUC[0-t]) of LY2874455
Area under the concentration-time curve from time 0 to the end of the dosing interval (e.g., BID) calculated by a combination of linear and logarithmic trapezoidal methods (linear-up/log-down method).
Measured: Part A and B: Cycle 1, Day 1, Pre-Dose, 0.5 Hr (H), 1 H, 2 H, 4H,8 H,12 H,24 H; Day 28, Pre-Dose, 0.5 H, 1 H, 2 H, 4 H, 8 H
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2010 (estimated)
- Study startDec 2010
- Primary completionAug 2014
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced CancerStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
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 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01212107
- Sponsor's protocol ID
- 13843
- Other IDs
- I4R-MC-FGAA
- Status last verified
- Jun 2019
- First submitted
- 16 Sep 2010
- Last updated
- 12 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Michael M, Bang YJ, Park YS, Kang YK, Kim TM, Hamid O, Thornton D, Tate SC, Raddad E, Tie J. A Phase 1 Study of LY2874455, an Oral Selective pan-FGFR Inhibitor, in Patients with Advanced Cancer. Target Oncol. 2017 Aug;12(4):463-474. doi: 10.1007/s11523-017-0502-9.
PubMed 28589492
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of LY2874455 to Assess Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy in Patients With Advanced Cancer.
- ClinicalTrials.gov ID
- NCT01212107
- Acronym / sponsor ID
- 13843
- Conditions
- Advanced Cancer
- Keywords
- Advanced cancer, Metastatic cancer, Oncology
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Aug 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 30 Sep 2010 (estimated)
- Results
- Posted 12 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is to determine the recommended Phase 2 regimen of study drug that may be safely administered to participants with advanced and or metastatic cancer. The study consists of two parts: a dose escalation and a dose confirmation.
Detailed description
Phase 1, first human dose study
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| Part A: 2 mg FGF Receptor QD | Experimental | Drug: FGF ReceptorPart A: Dose escalation 2 milligrams (mg) FGF receptor given orally once daily (QD) for a minimum of (1) 28 day cycle. If participants are determined to be receiving benefit, study treatment may be continued for up to one (1) year (12 cycles of 28 days) |
| Part A: 4 mg FGF Receptor QD | Experimental | Drug: FGF ReceptorPart A: Dose escalation 4 mg FGF receptor given orally QD for a minimum of (1) 28 day cycle. If participants are determined to be receiving benefit, study treatment may be continued for up to one (1) year (12 cycles of 28 days) |
| Part A: 10 mg FGF Receptor QD | Experimental | Drug: FGF ReceptorPart A: Dose escalation 10 mg FGF receptor given orally QD for a minimum of (1) 28 day cycle. If participants are determined to be receiving benefit, study treatment may be continued for up to one (1) year (12 cycles of 28 days). |
| Part A: 10 mg FGF Receptor QD + Phosphate Binders | Experimental | Drug: FGF Receptor, Drug: Phosphate BindersPart A: Dose escalation 10 mg FGF receptor + phosphate binders given QD for a minimum of (1) 28 day cycle. If participants are determined to be receiving benefit, study treatment may be continued for up to one (1) year (12 cycles of 28 days) |
| Part A: 8 mg FGF Receptor BID | Experimental | Drug: FGF ReceptorPart A: Dose escalation 8 mg of FGF receptor given orally twice a day (BID) for a minimum of (1) 28 day cycle. If participants are determined to be receiving benefit, study treatment may be continued for up to one (1) year (12 cycles of 28 days) |
| Part A: 10 mg FGF Receptor BID | Experimental | Drug: FGF ReceptorPart A: Dose escalation 10 mg FGF receptor given orally BID for a minimum of (1) 28 day cycle. If participants are determined to be receiving benefit, study treatment may be continued for up to one (1) year (12 cycles of 28 days) |
| Part A: 14 mg FGF Receptor BID | Experimental | Drug: FGF ReceptorPart A: Dose escalation 14 FGF receptor given orally BID for a minimum of (1) 28 day cycle. If participants are determined to be receiving benefit, study treatment may be continued for up to one (1) year (12 cycles of 28 days) |
| Part A: 18 mg FGF Receptor BID | Experimental | Drug: FGF ReceptorPart A: Dose escalation 18 mg FGF receptor given orally BID for a minimum of (1) 28 day cycle. If participants are determined to be receiving benefit, study treatment may be continued for up to one (1) year (12 cycles of 28 days) |
| Part A: 24 mg FGF Receptor BID | Experimental | Drug: FGF ReceptorPart A: Dose escalation 24 mg FGF receptor given orally BID for a minimum of (1) 28 day cycle. If participants are determined to be receiving benefit, study treatment may be continued for up to one (1) year (12 cycles of 28 days). |
| Part A: 18 mg FGF Receptor BID Extension | Experimental | Drug: FGF ReceptorPart A: Dose escalation 18 mg FGF Receptor given orally BID for a minimum of (1) 28 day cycle. If participants are determined to be receiving benefit, study treatment may be continued for up to one (1) year (12 cycles of 28 days) |
| Part A: 16 mg FGF Receptor BID | Experimental | Drug: FGF ReceptorPart A: Dose escalation 16 mg FGF Receptor given orally BID for a minimum of (1) 28 day cycle. If participants are determined to be receiving benefit, study treatment may be continued for up to one (1) year (12 cycles of 28 days) |
| Part B: 16 mg FGF Receptor BID | Experimental | Drug: FGF ReceptorPart B: Dose determined by part a dose escalation 16 mg FGF Receptor given orally BID for a minimum of (1) 28 day cycle. If participants are determined to be receiving benefit, study treatment may be continued for up to one (1) year (12 cycles of 28 days) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Have histological or cytological evidence of a diagnosis of cancer (solid tumors, lymphoma, or chronic lymphocytic leukemia) that is advanced and/or metastatic and for which all standard therapies have failed
- Have the presence of measurable or non-measurable disease
- Have given written informed consent prior to any study-specific procedures
- Have adequate organ function including:
- Have a performance status of 0, 1, or 2 on the Eastern Cooperative Oncology Group (ECOG) scale
Key exclusion criteria (11 listed)
- Have received treatment with an investigational drug, which has not received regulatory approval for any indication, within 28 days of study treatment with LY2874455
- Currently taking agents to control serum phosphate or calcium levels. This includes dietary restrictions
- Have medical conditions that, in the opinion of the investigator, would preclude participation in this study
- Have symptomatic central nervous system (CNS) malignancy or metastasis. Participants with treated CNS metastases are eligible provided their disease is radiographically stable, asymptomatic, and they are not currently receiving corticosteroids and/or anticonvulsants. Screening of asymptomatic participants without history of CNS metastases is not required
- Have a history of major organ transplant (for example: heart, lungs, liver, and kidney)
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 |
|---|---|---|
| FGF ReceptorAlso: LY2874455LY2874455 administered orally. | Drug | Part A: 10 mg FGF Receptor BID, Part A: 10 mg FGF Receptor QD, Part A: 10 mg FGF Receptor QD + Phosphate Binders, Part A: 14 mg FGF Receptor BID, Part A: 16 mg FGF Receptor BID, Part A: 18 mg FGF Receptor BID, Part A: 18 mg FGF Receptor BID Extension, Part A: 2 mg FGF Receptor QD, Part A: 24 mg FGF Receptor BID, Part A: 4 mg FGF Receptor QD, Part A: 8 mg FGF Receptor BID, Part B: 16 mg FGF Receptor BID |
| Phosphate Binders | Drug | Part A: 10 mg FGF Receptor QD + Phosphate Binders |
Primary outcome
Recommended Dose for Phase 2 Studies : Maximum Tolerated Dose (MTD)
Time frame: Baseline Up to 32 Weeks
MTD was determined after the evaluation of Part A portion of the trial. Dose escalation proceeded at 1.3 times the preceding cohort once a Grade 3 non-laboratory toxicity or Grade 2 laboratory toxicity was noted in ≥ 1 participant until MTD was achieved. Doses up to 24 mg (48 mg/day) were evaluated in Part A. The effects at this dose and at 18 mg (36 mg/day) suggested that a reasonable number of participants might not tolerate LY2874455 for chronic administration at these dose levels because of the constellation of effects observed individually or in combination in participants at these dose levels. Therefore, the dose of 16 mg BID of LY2874455 (total dose 32 mg per day) was selected as the initial dose for Part B. Selection of the dose level was based on the tolerability of this dose and without specific toxicities identified.
4 secondary outcomes
Number of Participants With Treatment-Emergent Adverse Events
Time frame: Baseline Up to 60 Weeks
Percentage of Participants With Best Overall Response Rate (BORR) and Objective Response Rate (ORR)
Time frame: BORR: Baseline Up to 60 Weeks ; ORR: Baseline Up to 60 Weeks
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY2874455
Time frame: Part A and B: Cycle 1, Day 1, Pre-Dose, 0.5 Hr (H), 1 H, 2 H, 4H,8 H,12 H,24 H; Day 28, Pre-Dose, 0.5 H, 1 H, 2 H, 4 H, 8 H
Pharmacokinetics (PK): Area Under the Concentration vs Time Curve 0 to Tau ( AUC[0-t]) of LY2874455
Time frame: Part A and B: Cycle 1, Day 1, Pre-Dose, 0.5 Hr (H), 1 H, 2 H, 4H,8 H,12 H,24 H; Day 28, Pre-Dose, 0.5 H, 1 H, 2 H, 4 H, 8 H
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28589492Michael M, Bang YJ, Park YS, Kang YK, Kim TM, Hamid O, Thornton D, Tate SC, Raddad E, Tie J. A Phase 1 Study of LY2874455, an Oral Selective pan-FGFR Inhibitor, in Patients with Advanced Cancer. Target Oncol. 2017 Aug;12(4):463-474. doi: 10.1007/s11523-017-0502-9.
- Individual participant dataSharing planned: No
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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 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing FGF Receptor and Phosphate Binders in people with Advanced Cancer, run by Eli Lilly and Company at 3 sites in 2 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 12 inclusion and 11 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 12 Jun 2019. 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 Australia, South Korea. 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?
Yes. Results are posted in the registry (first posted 12 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 : Maximum Tolerated Dose (MTD) (time frame: Baseline Up to 32 Weeks). 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 NCT01212107, which also lists 1 linked publication.
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 12 Jun 2019.