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

NCT ID: NCT00543387

Last Updated: 2024-06-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-27
• Study Completion Date: 2011-04-04

Brief Summary

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MK-5108 200 mg BID (Panel 1)

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).

Group Type: EXPERIMENTAL

MK-5108

Intervention Type: DRUG

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.

MK-5108 400 mg BID (Panel 1)

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).

Group Type: EXPERIMENTAL

MK-5108

Intervention Type: DRUG

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.

MK-5108 800 mg BID (Panel 1)

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).

Group Type: EXPERIMENTAL

MK-5108

Intervention Type: DRUG

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.

MK-5108 1200 mg BID (Panel 1)

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).

Group Type: EXPERIMENTAL

MK-5108

Intervention Type: DRUG

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.

MK-5108 1500 mg BID (Panel 1)

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).

Group Type: EXPERIMENTAL

MK-5108

Intervention Type: DRUG

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.

MK-5108 1800 mg BID (Panel 1)

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).

Group Type: EXPERIMENTAL

MK-5108

Intervention Type: DRUG

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.

MK-5108 100 mg BID + 60 mg/m^2 Docetaxel (Panel 2)

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.

Group Type: EXPERIMENTAL

MK-5108

Intervention Type: DRUG

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.

docetaxel

Intervention Type: DRUG

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.

MK-5108 150 mg BID + 60 mg/m^2 Docetaxel (Panel 2)

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.

Group Type: EXPERIMENTAL

MK-5108

Intervention Type: DRUG

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.

docetaxel

Intervention Type: DRUG

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.

MK-5108 225 mg BID + 60 mg/m^2 Docetaxel (Panel 2)

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.

Group Type: EXPERIMENTAL

MK-5108

Intervention Type: DRUG

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.

docetaxel

Intervention Type: DRUG

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.

MK-5108 100 mg BID + 60 mg/m^2 Docetaxel (Crossover)

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.

Group Type: EXPERIMENTAL

MK-5108

Intervention Type: DRUG

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.

docetaxel

Intervention Type: DRUG

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.

MK-5108 150 mg BID + 60 mg/m^2 Docetaxel (Crossover)

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.

Group Type: EXPERIMENTAL

MK-5108

Intervention Type: DRUG

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.

docetaxel

Intervention Type: DRUG

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.

Interventions

MK-5108

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.

Intervention Type: DRUG

docetaxel

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.

Intervention Type: DRUG

Other Intervention Names

Taxotere

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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.

Reference Type: RESULT

PMID: 26620496 (View on PubMed)

Other Identifiers

2007_598

Identifier Type: OTHER

Identifier Source: secondary_id

MK-5108-001

Identifier Type: OTHER

Identifier Source: secondary_id

5108-001

Identifier Type: -

Identifier Source: org_study_id