Treatment of Participants With Advanced and/or Refractory Solid Tumors (MK-5108-001 AM4)
This study has been completed.
Sponsor:
Merck
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00543387
First received: October 12, 2007
Last updated: April 26, 2011
Last verified: April 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cancer, Neoplasms, Tumors |
Drug: MK-5108 Drug: docetaxel |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I Investigation of MK-5108 and MK-5108 With Docetaxel in Patients With Advanced Solid Tumors |
Resource links provided by NLM:
Further study details as provided by Merck:
Primary Outcome Measures:
- Number of participants who experience an adverse event [ Time Frame: From Day 1 of study treatment until 30 days following the last dose of study treatment ] [ Designated as safety issue: Yes ]
- Number of participants with dose limiting toxicities (DLTs) [ Time Frame: Day 1 to Day 21 of study treatment (Cycle 1) ] [ Designated as safety issue: Yes ]
| Enrollment: | 37 |
| Study Start Date: | March 2008 |
| Study Completion Date: | April 2011 |
| Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: MK-5108
Participants entered into the MK-5108 group (Panel 1) will receive MK-5108 as monotherapy; MK-5108 will be administered to cohorts of participants in sequentially rising doses. 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.
|
Drug: 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.
|
|
Experimental: MK-5108 + Docetaxel
The MK-5108 + Docetaxel group (Panel 2) will receive MK-5108 in combination with an intravenous (I.V.) dose of docetaxel (60 mg/m^2). MK-5108 will be administered to cohorts of participants in sequentially rising doses. MK-5108 will be administered orally, every 12 hours (Q12H) during the first 2 days of each cycle. Cycle length will be 21 days in Panel 2.
|
Drug: 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.
Drug: docetaxel
intravenous (I.V.) dose of docetaxel (60 mg/m^2)
Other Name: Taxotere
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
No Contacts or Locations Provided
More Information
No publications provided
| Responsible Party: | Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp |
| ClinicalTrials.gov Identifier: | NCT00543387 History of Changes |
| Other Study ID Numbers: | MK-5108-001, 2007_598 |
| Study First Received: | October 12, 2007 |
| Last Updated: | April 26, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Neoplasms Docetaxel Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013