Cancer, Neoplasms, TumorsPhase 1NCT00543387

Treatment of Participants With Advanced and/or Refractory Solid Tumors (MK-5108-001)

A Phase 1 study testing MK-5108 and docetaxel in people with Cancer, Neoplasms, Tumors, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Cancer, Neoplasms, Tumors
What is being tested?: MK-5108 and docetaxel
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 35 participants
Where: No sites listed yet
Study dates: 27 Mar 2008to 4 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

Participant has a histologically-confirmed metastatic or locally advanced solid tumor that has failed to respond to standard therapy or progressed with standard therapy

Who cannot join

Participant has had chemotherapy, radiotherapy or biological therapy within 4 weeks prior to study start or has not recovered from adverse events caused by therapy more than 4 weeks earlier
Participant is currently participating or has participated in a study with an investigational compound or device within 4 weeks prior to signing informed consent
Participant has received more than 2 courses of chemotherapy for metastatic disease
Participant has had prolonged neutropenia or neutropenia with fever from previous chemotherapy treatment
Participant has a primary central nervous system tumor
Participant is a regular or recreational user of any illicit drugs or has a recent history within the last year of drug or alcohol abuse

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Participant is pregnant, breastfeeding or planning to have children during the study
Participant is Human Immunodeficiency Virus (HIV) positive
Participant has a history of Hepatitis B or C

About this study

Official title: A Phase I Investigation of MK-5108 and MK-5108 With Docetaxel in Patients With Advanced Solid Tumors

This study will investigate the safety, side effects and how well the body tolerates MK-5108 as well as determine different doses of MK-5108 in participants with advanced and/or refractory solid tumors. The corresponding primary hypotheses of this study are that 1) administration of oral MK-5108 (twice daily for 2 out of 14-21 days) to participants with advanced and/or refractory solid tumors will be safe and tolerable, and that 2) the spectrum of side effects observed in these participants after administration of oral MK-5108 alone and in combination with docetaxel will be dose-dependent and allow for definition of a maximum tolerated dose (MTD).

Conditions: Cancer, Neoplasms, Tumors
Being tested: MK-5108, docetaxel
Medical subject headings: Neoplasms

What participants receive

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

MK-5108Drug
MK-5108 will be administered orally, every 12 hours (Q12H) during the first 2 days of each cycle. Cycle length will be 14-21 days in Panel 1 and 21 days in Panel 2.
docetaxelDrug
Also called Taxotere
Docetaxel will be administered intravenously (I.V.) at a dose of 60 mg/m^2 Q12H during the first 2 days of each 21-day cycle.

Study groups in NCT00543387
Study group	Role	What they receive
MK-5108 200 mg BID (Panel 1)	Experimental	Participants receive 200 mg of MK-5108 orally twice daily (BID) the first 2 days of a 14-day cycle (cycle extended to 21 days if ≥Grade 2 toxicity observed). Receives: Drug: MK-5108
MK-5108 400 mg BID (Panel 1)	Experimental	Participants receive 400 mg of MK-5108 orally BID the first 2 days of a 14-day cycle (cycle extended to 21 days if ≥Grade 2 toxicity observed). Receives: Drug: MK-5108
MK-5108 800 mg BID (Panel 1)	Experimental	Participants receive 800 mg of MK-5108 orally BID the first 2 days of a 14-day cycle (cycle extended to 21 days if ≥Grade 2 toxicity observed). Receives: Drug: MK-5108
MK-5108 1200 mg BID (Panel 1)	Experimental	Participants receive 1200 mg of MK-5108 orally BID the first 2 days of a 14-day cycle (cycle extended to 21 days if ≥Grade 2 toxicity observed). Receives: Drug: MK-5108
MK-5108 1500 mg BID (Panel 1)	Experimental	Participants receive 1500 mg of MK-5108 orally BID the first 2 days of a 14-day cycle (cycle extended to 21 days if ≥Grade 2 toxicity observed). Receives: Drug: MK-5108
MK-5108 1800 mg BID (Panel 1)	Experimental	Participants receive 1800 mg of MK-5108 orally BID the first 2 days of a 14-day cycle (cycle extended to 21 days if ≥Grade 2 toxicity observed). Receives: Drug: MK-5108
MK-5108 100 mg BID + 60 mg/m^2 Docetaxel (Panel 2)	Experimental	Participants receive 100 mg of MK-5108 orally BID in combination with 60 mg/m^2 Docetaxel administered intravenously (IV) the first 2 days of a 21-day cycle. Receives: Drug: MK-5108; Drug: docetaxel
MK-5108 150 mg BID + 60 mg/m^2 Docetaxel (Panel 2)	Experimental	Participants receive 150 mg of MK-5108 orally BID in combination with 60 mg/m^2 Docetaxel administered IV the first 2 days of a 21-day cycle. Receives: Drug: MK-5108; Drug: docetaxel
MK-5108 225 mg BID + 60 mg/m^2 Docetaxel (Panel 2)	Experimental	Participants receive 150 mg of MK-5108 orally BID in combination with 60 mg/m^2 Docetaxel administered IV the first 2 days of a 21-day cycle. Receives: Drug: MK-5108; Drug: docetaxel
MK-5108 100 mg BID + 60 mg/m^2 Docetaxel (Crossover)	Experimental	After receiving treatment in Panel 1, one participant crossed over to Panel 2 per protocol following disease progression to receive 100 mg of MK-5108 orally BID in combination with 60 mg/m^2 Docetaxel administered IV the first 2 days of a 21-day cycle. Receives: Drug: MK-5108; Drug: docetaxel
MK-5108 150 mg BID + 60 mg/m^2 Docetaxel (Crossover)	Experimental	After receiving treatment in Panel 1, participants crossed over to Panel 2 per protocol following disease progression to receive 150 mg of MK-5108 orally BID in combination with 60 mg/m^2 Docetaxel administered IV the first 2 days of a 21-day cycle. Receives: Drug: MK-5108; Drug: docetaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Who Experienced an Adverse Event (AE)
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of the Sponsor's product, was also an AE. The number of participants who experienced an AE was reported for each dose level group.
Measured: From Day 1 of study treatment until 30 days following the last dose of study treatment (up to 577 days)
Number of Participants With Dose Limiting Toxicities (DLTs)
DLTs were AEs considered related to study drug that prevented escalation of the drug dose. Hematologic DLTs included any Grade 5 hematologic toxicity, Grade 4 neutropenia lasting for ≥7 days in duration, Grade 3 or Grade 4 neutropenia with fever >38.5°C and/or infection requiring antibiotic or anti-fungal treatment, and Grade 4 thrombocytopenia (≤25.0 x 10^9/L). Non-hematologic DLT was defined as any Grade 3, 4, or 5 non-hematologic toxicity, with the specific exceptions of: Grade 3 nausea or Grade 3 vomiting, Grade 3 diarrhea, or Grade 3 dehydration occurring in the setting of inadequate compliance with supportive care and lasting for <48 hours, alopecia, inadequately treated hypersensitivity reactions, or Grade 3 elevated transaminases of ≤1 week in duration. Any drug-related AE leading to a dose modification of MK-5108, or any unresolved drug-related toxicity persisting>6 weeks, was also considered a DLT.
Measured: Day 1 to Day 21 of study treatment (Cycle 1 for Panel 1, Panel 2, or Crossover)

Timeline

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

27 Mar 20084 Apr 2011

First posted15 Oct 2007 (estimated)
Study start27 Mar 2008
Primary completion4 Apr 2011
Study completion4 Apr 2011

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 Cancer, Neoplasms, TumorsStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe 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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 35 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00543387
Sponsor's protocol ID: 5108-001
Other IDs: 2007_598, MK-5108-001
Status last verified: May 2024
First submitted: 12 Oct 2007
Last updated: 5 Jun 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Publications

Amin M, Minton SE, LoRusso PM, Krishnamurthi SS, Pickett CA, Lunceford J, Hille D, Mauro D, Stein MN, Wang-Gillam A, Trull L, Lockhart AC. A phase I study of MK-5108, an oral aurora a kinase inhibitor, administered both as monotherapy and in combination with docetaxel, in patients with advanced or refractory solid tumors. Invest New Drugs. 2016 Feb;34(1):84-95. doi: 10.1007/s10637-015-0306-7. Epub 2015 Dec 1.
PubMed 26620496

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?

Official record

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All Cancer, Neoplasms, Tumors trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I Investigation of MK-5108 and MK-5108 With Docetaxel in Patients With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT00543387
Acronym / sponsor ID: 5108-001
Conditions: Cancer, Neoplasms, Tumors
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 35 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 27 Mar 2008 (actual)
Primary completion: 4 Apr 2011 (actual)
Study completion: 4 Apr 2011 (actual)
First posted: 15 Oct 2007 (estimated)
Results: Posted 9 Nov 2018

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 11

Arm	Type	Receives
MK-5108 200 mg BID (Panel 1)	Experimental	Drug: MK-5108Participants receive 200 mg of MK-5108 orally twice daily (BID) the first 2 days of a 14-day cycle (cycle extended to 21 days if ≥Grade 2 toxicity observed).
MK-5108 400 mg BID (Panel 1)	Experimental	Drug: MK-5108Participants receive 400 mg of MK-5108 orally BID the first 2 days of a 14-day cycle (cycle extended to 21 days if ≥Grade 2 toxicity observed).
MK-5108 800 mg BID (Panel 1)	Experimental	Drug: MK-5108Participants receive 800 mg of MK-5108 orally BID the first 2 days of a 14-day cycle (cycle extended to 21 days if ≥Grade 2 toxicity observed).
MK-5108 1200 mg BID (Panel 1)	Experimental	Drug: MK-5108Participants receive 1200 mg of MK-5108 orally BID the first 2 days of a 14-day cycle (cycle extended to 21 days if ≥Grade 2 toxicity observed).
MK-5108 1500 mg BID (Panel 1)	Experimental	Drug: MK-5108Participants receive 1500 mg of MK-5108 orally BID the first 2 days of a 14-day cycle (cycle extended to 21 days if ≥Grade 2 toxicity observed).
MK-5108 1800 mg BID (Panel 1)	Experimental	Drug: MK-5108Participants receive 1800 mg of MK-5108 orally BID the first 2 days of a 14-day cycle (cycle extended to 21 days if ≥Grade 2 toxicity observed).
MK-5108 100 mg BID + 60 mg/m^2 Docetaxel (Panel 2)	Experimental	Drug: MK-5108, Drug: docetaxelParticipants receive 100 mg of MK-5108 orally BID in combination with 60 mg/m^2 Docetaxel administered intravenously (IV) the first 2 days of a 21-day cycle.
MK-5108 150 mg BID + 60 mg/m^2 Docetaxel (Panel 2)	Experimental	Drug: MK-5108, Drug: docetaxelParticipants receive 150 mg of MK-5108 orally BID in combination with 60 mg/m^2 Docetaxel administered IV the first 2 days of a 21-day cycle.
MK-5108 225 mg BID + 60 mg/m^2 Docetaxel (Panel 2)	Experimental	Drug: MK-5108, Drug: docetaxelParticipants receive 150 mg of MK-5108 orally BID in combination with 60 mg/m^2 Docetaxel administered IV the first 2 days of a 21-day cycle.
MK-5108 100 mg BID + 60 mg/m^2 Docetaxel (Crossover)	Experimental	Drug: MK-5108, Drug: docetaxelAfter receiving treatment in Panel 1, one participant crossed over to Panel 2 per protocol following disease progression to receive 100 mg of MK-5108 orally BID in combination with 60 mg/m^2 Docetaxel administered IV the first 2 days of a 21-day cycle.
MK-5108 150 mg BID + 60 mg/m^2 Docetaxel (Crossover)	Experimental	Drug: MK-5108, Drug: docetaxelAfter receiving treatment in Panel 1, participants crossed over to Panel 2 per protocol following disease progression to receive 150 mg of MK-5108 orally BID in combination with 60 mg/m^2 Docetaxel administered IV the first 2 days of a 21-day cycle.

Who may qualify

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

Key inclusion criteria (1 listed)

Participant has a histologically-confirmed metastatic or locally advanced solid tumor that has failed to respond to standard therapy or progressed with standard therapy

Key exclusion criteria (9 listed)

Participant has had chemotherapy, radiotherapy or biological therapy within 4 weeks prior to study start or has not recovered from adverse events caused by therapy more than 4 weeks earlier
Participant is currently participating or has participated in a study with an investigational compound or device within 4 weeks prior to signing informed consent
Participant has received more than 2 courses of chemotherapy for metastatic disease
Participant has had prolonged neutropenia or neutropenia with fever from previous chemotherapy treatment
Participant has a primary central nervous system tumor

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
MK-5108MK-5108 will be administered orally, every 12 hours (Q12H) during the first 2 days of each cycle. Cycle length will be 14-21 days in Panel 1 and 21 days in Panel 2.	Drug	MK-5108 100 mg BID + 60 mg/m^2 Docetaxel (Crossover), MK-5108 100 mg BID + 60 mg/m^2 Docetaxel (Panel 2), MK-5108 1200 mg BID (Panel 1), MK-5108 150 mg BID + 60 mg/m^2 Docetaxel (Crossover), MK-5108 150 mg BID + 60 mg/m^2 Docetaxel (Panel 2), MK-5108 1500 mg BID (Panel 1), MK-5108 1800 mg BID (Panel 1), MK-5108 200 mg BID (Panel 1), MK-5108 225 mg BID + 60 mg/m^2 Docetaxel (Panel 2), MK-5108 400 mg BID (Panel 1), MK-5108 800 mg BID (Panel 1)
docetaxelAlso: TaxotereDocetaxel will be administered intravenously (I.V.) at a dose of 60 mg/m^2 Q12H during the first 2 days of each 21-day cycle.	Drug	MK-5108 100 mg BID + 60 mg/m^2 Docetaxel (Crossover), MK-5108 100 mg BID + 60 mg/m^2 Docetaxel (Panel 2), MK-5108 150 mg BID + 60 mg/m^2 Docetaxel (Crossover), MK-5108 150 mg BID + 60 mg/m^2 Docetaxel (Panel 2), MK-5108 225 mg BID + 60 mg/m^2 Docetaxel (Panel 2)

Primary outcome

Number of Participants Who Experienced an Adverse Event (AE)
Time frame: From Day 1 of study treatment until 30 days following the last dose of study treatment (up to 577 days)
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of the Sponsor's product, was also an AE. The number of participants who experienced an AE was reported for each dose level group.
Number of Participants With Dose Limiting Toxicities (DLTs)
Time frame: Day 1 to Day 21 of study treatment (Cycle 1 for Panel 1, Panel 2, or Crossover)
DLTs were AEs considered related to study drug that prevented escalation of the drug dose. Hematologic DLTs included any Grade 5 hematologic toxicity, Grade 4 neutropenia lasting for ≥7 days in duration, Grade 3 or Grade 4 neutropenia with fever >38.5°C and/or infection requiring antibiotic or anti-fungal treatment, and Grade 4 thrombocytopenia (≤25.0 x 10^9/L). Non-hematologic DLT was defined as any Grade 3, 4, or 5 non-hematologic toxicity, with the specific exceptions of: Grade 3 nausea or Grade 3 vomiting, Grade 3 diarrhea, or Grade 3 dehydration occurring in the setting of inadequate compliance with supportive care and lasting for <48 hours, alopecia, inadequately treated hypersensitivity reactions, or Grade 3 elevated transaminases of ≤1 week in duration. Any drug-related AE leading to a dose modification of MK-5108, or any unresolved drug-related toxicity persisting>6 weeks, was also considered a DLT.

Results and safety

Results posted to the registry on 9 Nov 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MK-5108 200 mg BID (Panel 1)	3	0
MK-5108 400 mg BID (Panel 1)	3	0
MK-5108 800 mg BID (Panel 1)	3	0
MK-5108 1200 mg BID (Panel 1)	3	0
MK-5108 1500 mg BID (Panel 1)	3	0
MK-5108 1800 mg BID (Panel 1)	3	0
MK-5108 100 mg BID + 60 mg/m^2 Docetaxel (Panel 2)	6	0
MK-5108 150 mg BID + 60 mg/m^2 Docetaxel (Panel 2)	6	0
MK-5108 225 mg BID + 60 mg/m^2 Docetaxel (Panel 2)	5	0
MK-5108 100 mg BID + 60 mg/m^2 Docetaxel (Crossover)	0	0
MK-5108 150 mg BID + 60 mg/m^2 Docetaxel (Crossover)	0	0

Primary outcome: Number of Participants Who Experienced an Adverse Event (AE)

Time frame: From Day 1 of study treatment until 30 days following the last dose of study treatment (up to 577 days). Count of participants. Unit: Participants

Measure	MK-5108 200 mg BID (Panel 1) n = 3	MK-5108 400 mg BID (Panel 1) n = 3	MK-5108 800 mg BID (Panel 1) n = 3	MK-5108 1200 mg BID (Panel 1) n = 3	MK-5108 1500 mg BID (Panel 1) n = 3	MK-5108 1800 mg BID (Panel 1) n = 3	MK-5108 100 mg BID + 60 mg/m^2 Docetaxel (Panel 2) n = 6	MK-5108 150 mg BID + 60 mg/m^2 Docetaxel (Panel 2) n = 6	MK-5108 225 mg BID + 60 mg/m^2 Docetaxel (Panel 2) n = 5	MK-5108 100 mg BID + 60 mg/m^2 Docetaxel (Crossover) n = 1	MK-5108 150 mg BID + 60 mg/m^2 Docetaxel (Crossover) n = 3
Value	3	3	3	3	3	3	6	6	5	1	3

Population analysed: All participants that received one or more doses of study medication. Four participants who received MK-5108 monotherapy in Panel 1 and then crossed over to receive combination treatment in Panel 2 (Crossover) were included in both respective treatment groups and AEs were reported according to treatment received.

Primary outcome: Number of Participants With Dose Limiting Toxicities (DLTs)

Time frame: Day 1 to Day 21 of study treatment (Cycle 1 for Panel 1, Panel 2, or Crossover). Count of participants. Unit: Participants

Measure	MK-5108 200 mg BID (Panel 1) n = 3	MK-5108 400 mg BID (Panel 1) n = 3	MK-5108 800 mg BID (Panel 1) n = 3	MK-5108 1200 mg BID (Panel 1) n = 3	MK-5108 1500 mg BID (Panel 1) n = 3	MK-5108 1800 mg BID (Panel 1) n = 3	MK-5108 100 mg BID + 60 mg/m^2 Docetaxel (Panel 2) n = 6	MK-5108 150 mg BID + 60 mg/m^2 Docetaxel (Panel 2) n = 6	MK-5108 225 mg BID + 60 mg/m^2 Docetaxel (Panel 2) n = 5	MK-5108 100 mg BID + 60 mg/m^2 Docetaxel (Crossover) n = 1	MK-5108 150 mg BID + 60 mg/m^2 Docetaxel (Crossover) n = 3
Value	0	0	0	0	0	0	1	0	2	0	0

Population analysed: All participants that received one or more doses of study medication. Participants who received MK-5108 monotherapy in Panel 1 and then crossed over to receive combination treatment in Panel 2 (Crossover) were included in both respective treatment groups and DLTs were reported according to treatment received.

Adverse events

Time frame: From Day 1 of study treatment until 30 days following the last dose of study treatment (up to 577 days). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MK-5108 200 mg BID (Panel 1)	0 of 3 (0%)	3 of 3 (100%)	0 of 3
MK-5108 400 mg BID (Panel 1)	1 of 3 (33.3%)	2 of 3 (66.7%)	0 of 3
MK-5108 800 mg BID (Panel 1)	1 of 3 (33.3%)	3 of 3 (100%)	0 of 3
MK-5108 1200 mg BID (Panel 1)	0 of 3 (0%)	3 of 3 (100%)	0 of 3
MK-5108 1500 mg BID (Panel 1)	1 of 3 (33.3%)	3 of 3 (100%)	1 of 3
MK-5108 1800 mg BID (Panel 1)	0 of 3 (0%)	2 of 3 (66.7%)	0 of 3
MK-5108 100 mg BID + 60 mg/m2 Docetaxel (Panel 2)	1 of 6 (16.7%)	5 of 6 (83.3%)	0 of 6
MK-5108 150 mg BID + 60 mg/m2 Docetaxel (Panel 2)	4 of 6 (66.7%)	6 of 6 (100%)	0 of 6
MK-5108 225 mg BID + 60 mg/m2 Docetaxel (Panel 2)	4 of 5 (80%)	4 of 5 (80%)	0 of 5
MK-5108 100 mg BID + 60 mg/m2 Docetaxel (Crossover)	0 of 1 (0%)	1 of 1 (100%)	0 of 1
MK-5108 150 mg BID + 60 mg/m2 Docetaxel (Crossover)	0 of 3 (0%)	3 of 3 (100%)	0 of 3

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 26620496Amin M, Minton SE, LoRusso PM, Krishnamurthi SS, Pickett CA, Lunceford J, Hille D, Mauro D, Stein MN, Wang-Gillam A, Trull L, Lockhart AC. A phase I study of MK-5108, an oral aurora a kinase inhibitor, administered both as monotherapy and in combination with docetaxel, in patients with advanced or refractory solid tumors. Invest New Drugs. 2016 Feb;34(1):84-95. doi: 10.1007/s10637-015-0306-7. Epub 2015 Dec 1.
Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

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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.

Medical Director study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MK-5108 and docetaxel in people with Cancer, Neoplasms, Tumors, run by Merck Sharp & Dohme LLC.

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 1 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 5 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

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 9 Nov 2018). 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?

Number of Participants Who Experienced an Adverse Event (AE) (time frame: From Day 1 of study treatment until 30 days following the last dose of study treatment (up to 577 days)). The study lists 2 primary outcomes in all. 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 NCT00543387, 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 5 Jun 2024.