Advanced CancerPhase 1NCT01394003

A Study of LY2584702 in Participants With Advanced Cancer

A Phase 1 study testing LY2584702 in people with Advanced Cancer, run by Eli Lilly and Company at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The main purpose of this trial is to determine a recommended Phase 2 dose of LY2584702 that may be safely administered to participants with advanced/metastatic cancer. 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?: LY2584702
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 34 participants
Where: 2 sitesUnited States
Study dates: Nov 2008to Apr 2011
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 advanced and/or metastatic cancer (solid tumors) that is refractory to standard therapy and/or therapies known to provide clinical benefit, or for which no standard therapy exists
Have the presence of disease amenable to efficacy assessment as defined by the Response Evaluation Criteria in Solid Tumors. Participants who have advanced non-measurable disease with elevation of a validated tumor marker may be eligible, if discussed and agreed upon by the investigator and the sponsor
Participants entering Part C of the study must have a tumor that is safely amenable to 2 biopsies (one pre-treatment and one on-treatment biopsy for the same tumor). Participants in Part C of the study must agree to biopsy procedures at time of consent
Have adequate hematologic, renal, and hepatic organ function
Have a performance status of less than or equal to 2 on the Eastern Cooperative Oncology Group (ECOG) scale
Have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, cancer-related hormonal therapy (with the exception of continuing gonadotropic releasing hormone (GnRH) agonist therapy for participants with prostate cancer, or anti-estrogen therapy [for example, an aromatase inhibitor] for participants with breast cancer), or other investigational therapy for at least 3 weeks (6 weeks for mitomycin-C or nitrosoureas) prior to study enrollment and recovered from the acute effects of therapy

Show all 11Show fewer

Are reliable and willing to be available for the duration of the study and are willing to follow study procedures
Males and females with reproductive potential must agree to use medically approved contraceptive precautions during the trial and for 3 months following the last dose of study drug
Females with child bearing potential must have had a negative serum pregnancy test less than or equal to 7 days prior to the first dose of study drug
Have an estimated life expectancy of greater than or equal to 12 weeks
Are able to swallow capsules

Who cannot join

Have received treatment within 3 weeks of the initial dose of study drug with a drug that has not received regulatory approval for any indication
Have 1 or more serious preexisting 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 metastasis is not required
Have hematologic malignancies, or lymphoma
Females who are pregnant or lactating
Have a second primary malignancy that, in the judgement of the investigator and sponsor, may affect the interpretation of results
Have bleeding diathesis

Trial locations and contacts

2 sites in 1 country.

United States2 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.
San Antonio, Texas
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.
Santa Monica, California

Other trials in United States

About this study

Official title: A Phase I Study of LY2584702 in Patient With Advanced or Metastatic Cancer

The main purpose of this trial is to determine a recommended Phase 2 dose of LY2584702 that may be safely administered to participants with advanced/metastatic cancer.

Conditions: Advanced Cancer
Being tested: LY2584702
Keywords: Advanced cancer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LY2584702Drug
administered orally

Study groups in NCT01394003
Study group	Role	What they receive
LY2584702	Experimental	Oral dose escalation starting at 25 milligrams (mg), daily for 28 day cycles in Part A; oral dose escalation starting at 50 mg, twice daily for 28 day cycles in Part B; oral dose with schedule determined by Parts A and B will be administered in Part C (dose confirmation). Part A: Participants received 25 mg, 50 mg, 100 mg and 200 mg once daily (QD) and 300 mg twice daily (BID) of LY2584702 capsule, for a 28-day cycle during Part A of the study until the criteria for maximum tolerated dose (MTD) were met. Part B: Participants received 50 mg, 75 mg and 100 mg LY2584702 orally as a capsule, twice daily (BID) for a 28-day cycle during Part B of the study until the criteria for maximum tolerated dose (MTD) were met. Receives: Drug: LY2584702

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)
Based on the maximum tolerated dose (MTD): highest dose where <33% participants experienced a dose-limiting toxicity (DLT). DLTs were adverse events (AEs) during Cycle 1 that met any 1 of the following criteria using National Cancer Institute's (NCI) Common Terminology Criteria for AEs (CTCAE) grading: any ≥Grade 3 nonhematological toxicity (except nausea/vomiting, diarrhea or hypophosphatemia without maximal symptomatic/prophylactic treatment) that was not related to study disease, any ≥Grade 3 thrombocytopenia with bleeding, any Grade 4 hematological toxicity of >5 days duration or any febrile neutropenia. Investigators, together with the sponsor, could declare a DLT during Cycle 1 if a participant experienced increasing toxicity and it was clear that further treatment would expose the participant to excessive risk. The MTD was below the level required for efficacy, therefore, the study was terminated early and the recommended Phase 2 dose was not calculated.
Measured: Parts A and B, Baseline through Cycle 1 (1 cycle=28 days)

Secondary outcomes (4)

Pharmacokinetics, Maximum Plasma Concentration (Cmax)
Cmax results on Day 1 and on Day 8 (steady state) are reported.
Measured: Parts A and B, Cycle 1: Day 1 and Day 8 (predose, 0.5, 1, 2, 3, 5, 8 hours postdose)
Number of Participants With Tumor Response
Tumor response was defined using Response Evaluation Criteria In Solid Tumors (RECIST version 1.0) criteria. Complete Response (CR) was the disappearance of all target and non-target lesions and normalization of tumor marker levels of non-target lesions; Partial Response (PR) was at least a 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) was at least a 20% increase in the sum of the longest diameter of target lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions; Stable Disease (SD) was small changes that did not meet above criteria including persistence of 1 or more non-target lesion(s).
Measured: Parts A and B, Baseline through study completion [up to Cycle 10 (1 cycle=28 days)]
Pharmacokinetics, Area Under the Concentration-Time Curve (AUC) With Once Daily (QD) LY2584702 Dosing
Results for AUC from time 0 to infinity [AUC(0-inf)] and AUC from time 0 to 24 hours [AUC(0-24)] on Day 1 and Day 8 (steady state) are reported for participants on a QD LY2584702 dosing regimen.
Measured: Part A, Cycle 1: Day 1 and Day 8 (predose, 0.5, 1, 2, 3, 5, and 8 hours postdose)
Pharmacokinetics, Area Under the Concentration-Time Curve (AUC) With Twice Daily (BID) LY2584702 Dosing
Results for AUC from time 0 to infinity [AUC(0-inf)] and AUC from time 0 to 12 hours [AUC(0-12)] on Day 1 and Day 8 (steady state) are reported for participants with a BID LY2584702 dosing regimen.
Measured: Parts A and B, Cycle 1: Day 1 and Day 8 (predose, 0.5, 1, 2, 3, 5, and 8 hours postdose)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2008Apr 2011

First posted14 Jul 2011 (estimated)
Study startNov 2008
Primary completionApr 2011
Study completionApr 2011

Why it stopped: The pharmacokinetic properties of the molecule do not allow for further dose escalation or development.

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
Intervention model: Sequential
Masking: None (open label)
Enrolment: 34 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01394003
Sponsor's protocol ID: 12451
Other IDs: I3G-MC-JGCA
Status last verified: Aug 2018
First submitted: 1 Jun 2011
Last updated: 18 Jan 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Tolcher A, Goldman J, Patnaik A, Papadopoulos KP, Westwood P, Kelly CS, Bumgardner W, Sams L, Geeganage S, Wang T, Capen AR, Huang J, Joseph S, Miller J, Benhadji KA, Brail LH, Rosen LS. A phase I trial of LY2584702 tosylate, a p70 S6 kinase inhibitor, in patients with advanced solid tumours. Eur J Cancer. 2014 Mar;50(5):867-75. doi: 10.1016/j.ejca.2013.11.039. Epub 2014 Jan 15.
PubMed 24440085

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 18 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I Study of LY2584702 in Patient With Advanced or Metastatic Cancer
ClinicalTrials.gov ID: NCT01394003
Acronym / sponsor ID: 12451
Conditions: Advanced Cancer
Keywords: Advanced cancer
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: The pharmacokinetic properties of the molecule do not allow for further dose escalation or development.
Enrolment: 34 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Nov 2008
Primary completion: Apr 2011 (actual)
Study completion: Apr 2011 (actual)
First posted: 14 Jul 2011 (estimated)
Results: Posted 18 Jan 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The main purpose of this trial is to determine a recommended Phase 2 dose of LY2584702 that may be safely administered to participants with advanced/metastatic cancer.

Study design

Primary purpose: Treatment
Intervention model: Sequential
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
LY2584702	Experimental	Drug: LY2584702Oral dose escalation starting at 25 milligrams (mg), daily for 28 day cycles in Part A; oral dose escalation starting at 50 mg, twice daily for 28 day cycles in Part B; oral dose with schedule determined by Parts A and B will be administered in Part C (dose confirmation). Part A: Participants received 25 mg, 50 mg, 100 mg and 200 mg once daily (QD) and 300 mg twice daily (BID) of LY2584702 capsule, for a 28-day cycle during Part A of the study until the criteria for maximum tolerated dose (MTD) were met. Part B: Participants received 50 mg, 75 mg and 100 mg LY2584702 orally as a capsule, twice daily (BID) for a 28-day cycle during Part B of the study until the criteria for maximum tolerated dose (MTD) were met.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Have histological or cytological evidence of a diagnosis of advanced and/or metastatic cancer (solid tumors) that is refractory to standard therapy and/or therapies known to provide clinical benefit, or for which no standard therapy exists
Have the presence of disease amenable to efficacy assessment as defined by the Response Evaluation Criteria in Solid Tumors. Participants who have advanced non-measurable disease with elevation of a validated tumor marker may be eligible, if discussed and agreed upon by the investigator and the sponsor
Participants entering Part C of the study must have a tumor that is safely amenable to 2 biopsies (one pre-treatment and one on-treatment biopsy for the same tumor). Participants in Part C of the study must agree to biopsy procedures at time of consent
Have adequate hematologic, renal, and hepatic organ function
Have a performance status of less than or equal to 2 on the Eastern Cooperative Oncology Group (ECOG) scale

Key exclusion criteria (7 listed)

Have received treatment within 3 weeks of the initial dose of study drug with a drug that has not received regulatory approval for any indication
Have 1 or more serious preexisting 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 metastasis is not required
Have hematologic malignancies, or lymphoma
Females who are pregnant or lactating

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
LY2584702administered orally	Drug	LY2584702

Primary outcome

Recommended Dose for Phase 2 Studies/Maximum Tolerated Dose (MTD)
Time frame: Parts A and B, Baseline through Cycle 1 (1 cycle=28 days)
Based on the maximum tolerated dose (MTD): highest dose where <33% participants experienced a dose-limiting toxicity (DLT). DLTs were adverse events (AEs) during Cycle 1 that met any 1 of the following criteria using National Cancer Institute's (NCI) Common Terminology Criteria for AEs (CTCAE) grading: any ≥Grade 3 nonhematological toxicity (except nausea/vomiting, diarrhea or hypophosphatemia without maximal symptomatic/prophylactic treatment) that was not related to study disease, any ≥Grade 3 thrombocytopenia with bleeding, any Grade 4 hematological toxicity of >5 days duration or any febrile neutropenia. Investigators, together with the sponsor, could declare a DLT during Cycle 1 if a participant experienced increasing toxicity and it was clear that further treatment would expose the participant to excessive risk. The MTD was below the level required for efficacy, therefore, the study was terminated early and the recommended Phase 2 dose was not calculated.

4 secondary outcomes

Pharmacokinetics, Maximum Plasma Concentration (Cmax)
Time frame: Parts A and B, Cycle 1: Day 1 and Day 8 (predose, 0.5, 1, 2, 3, 5, 8 hours postdose)
Number of Participants With Tumor Response
Time frame: Parts A and B, Baseline through study completion [up to Cycle 10 (1 cycle=28 days)]
Pharmacokinetics, Area Under the Concentration-Time Curve (AUC) With Once Daily (QD) LY2584702 Dosing
Time frame: Part A, Cycle 1: Day 1 and Day 8 (predose, 0.5, 1, 2, 3, 5, and 8 hours postdose)
Pharmacokinetics, Area Under the Concentration-Time Curve (AUC) With Twice Daily (BID) LY2584702 Dosing
Time frame: Parts A and B, Cycle 1: Day 1 and Day 8 (predose, 0.5, 1, 2, 3, 5, and 8 hours postdose)

Results and safety

Results posted to the registry on 18 Jan 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
25 mg LY2584702 QD	3	3
50 mg LY2584702 QD	8	8
100 mg LY2584702 QD	3	3
200 mg LY2584702 QD	6	6
50 mg LY2584702 BID	3	3
75 mg LY2584702 BID	3	3
100 mg LY2584702 BID	6	6
300 mg LY2584702 BID	2	2

Primary outcome: Recommended Dose for Phase 2 Studies/Maximum Tolerated Dose (MTD)

Time frame: Parts A and B, Baseline through Cycle 1 (1 cycle=28 days). Number. Unit: milligrams (mg)

Measure	Part A n = 22	Part B n = 12
Value	NA	NA

Population analysed: All participants who received at least 1 dose of study drug.

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
25 mg LY2584702 QD	2 of 3 (66.7%)	2 of 3 (66.7%)	Not reported
50 mg LY2584702 QD	2 of 8 (25%)	7 of 8 (87.5%)	Not reported
100 mg LY2584702 QD	1 of 3 (33.3%)	2 of 3 (66.7%)	Not reported
200 mg LY2584702 QD	2 of 6 (33.3%)	5 of 6 (83.3%)	Not reported
50 mg LY2584702 BID	1 of 3 (33.3%)	3 of 3 (100%)	Not reported
75 mg LY2584702 BID	1 of 3 (33.3%)	3 of 3 (100%)	Not reported
100 mg LY2584702 BID	3 of 6 (50%)	6 of 6 (100%)	Not reported
300 mg LY2584702 BID	1 of 2 (50%)	2 of 2 (100%)	Not reported

Limitations and caveats (from the sponsor): Part C of the study was terminated because exposure at the maximum tolerated dose (MTD) was determined to be below the level required for efficacy.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 24440085Tolcher A, Goldman J, Patnaik A, Papadopoulos KP, Westwood P, Kelly CS, Bumgardner W, Sams L, Geeganage S, Wang T, Capen AR, Huang J, Joseph S, Miller J, Benhadji KA, Brail LH, Rosen LS. A phase I trial of LY2584702 tosylate, a p70 S6 kinase inhibitor, in patients with advanced solid tumours. Eur J Cancer. 2014 Mar;50(5):867-75. doi: 10.1016/j.ejca.2013.11.039. Epub 2014 Jan 15.

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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 (1-817-285-4559) or 1-317-615-4559 Mon-Fri Mon - Fri 9 AM - 5 PM 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 LY2584702 in people with Advanced Cancer, run by Eli Lilly and Company at 2 sites 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 11 inclusion and 7 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: stopped early, as of the sponsor's last update on 18 Jan 2019. 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 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?

Yes. Results are posted in the registry (first posted 18 Jan 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: Parts A and B, Baseline through Cycle 1 (1 cycle=28 days)). 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 NCT01394003, 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 18 Jan 2019.