A Study of MK-4827 in Combination With Standard Chemotherapy in Participants With Advanced Solid Tumors (MK-4827-008 AM1)
This study has been terminated.
Sponsor:
Merck
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT01110603
First received: April 22, 2010
Last updated: March 16, 2012
Last verified: March 2012
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Purpose
This study will find the dose limiting toxicities (DLTs), maximum tolerated dose (MTD), and recommended Phase 2 dose (RPTD) of MK4827 when administered in combination with standard doses of carboplatin, or carboplatin/paclitaxel, or carboplatin/liposomal doxorubicin in the treatment of advanced solid cancers in adults.
| Condition | Intervention | Phase |
|---|---|---|
|
Cancer: Solid Tumors |
Drug: MK-4827 Drug: carboplatin Drug: paclitaxel Drug: liposomal doxorubicin |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase Ib Dose Escalation Study of MK-4827 in Combination With Carboplatin, Carboplatin/Paclitaxel and Carboplatin/Liposomal Doxorubicin in Patients With Advanced Solid Tumors |
Resource links provided by NLM:
Further study details as provided by Merck:
Primary Outcome Measures:
- Number of participants with dose limiting toxicities (DLTs) [ Time Frame: Each cycle (21 or 28 Days) ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Number of participants with clinical and laboratory adverse events (AEs) [ Time Frame: Baseline to 30 days post last dose ] [ Designated as safety issue: No ]
| Enrollment: | 12 |
| Study Start Date: | July 2010 |
| Study Completion Date: | July 2011 |
| Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: MK-4827 + carboplatin |
Drug: MK-4827
Capsules, orally, once daily, on Days 1 and 3 of each 21- or 28-day Cycle, at the assigned dose level, starting at 40 mg per dose.
Drug: carboplatin
Intravenous infusion, at AUC 5, once, on Day 3 of each 21- or 28-day cycle
|
| Experimental: MK-4827 + carboplatin/paclitaxel |
Drug: MK-4827
Capsules, orally, once daily, on Days 1 and 3 of each 21- or 28-day Cycle, at the assigned dose level, starting at 40 mg per dose.
Drug: carboplatin
Intravenous infusion, at AUC 5, once, on Day 3 of each 21- or 28-day cycle
Drug: paclitaxel
Intravenous infusion, 175 mg/m2, once, on Day 3 of each 21-day cycle
|
| Experimental: MK-4827 + carboplatin/liposomal doxorubicin |
Drug: MK-4827
Capsules, orally, once daily, on Days 1 and 3 of each 21- or 28-day Cycle, at the assigned dose level, starting at 40 mg per dose.
Drug: carboplatin
Intravenous infusion, at AUC 5, once, on Day 3 of each 21- or 28-day cycle
Drug: liposomal doxorubicin
Intravenous infusion, 30 mg/m2, once, on Day 3 of each 28-day cycle
|
Detailed Description:
The decision to discontinue new enrollment is not related to any concerns about the safety profile of the product.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Participant has a locally advanced or metastatic solid tumor for which carboplatin, carboplatin/paclitaxel, or carboplatin/liposomal doxorubicin are the standard of care.
- Participant has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
Exclusion Criteria:
- Participant has had chemotherapy, radiotherapy, or biological therapy within 4 weeks prior to entering the study.
- Participant has had more than two prior lines of chemotherapy.
- Participant has known central nervous system metastases or a primary central nervous system tumor.
- Participant is pregnant or breastfeeding or expecting to conceive during the timeframe of the study.
- Participant is known to be human immunodeficiency virus (HIV) positive.
- Participant has a history of Hepatitis B or C.
- Participant has a symptomatic pleural effusion.
- Participant with a left ventricular ejection fraction (LVEF) below the institutional norm, or with prior exposure to doxorubicin is not eligible for the MK4827 + carboplatin/liposomal doxorubicin study arm.
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: | NCT01110603 History of Changes |
| Other Study ID Numbers: | 2010_528, MK-4827-008 |
| Study First Received: | April 22, 2010 |
| Last Updated: | March 16, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Merck:
|
Cancer Advanced Solid Tumors |
Additional relevant MeSH terms:
|
Neoplasms Doxorubicin Carboplatin Paclitaxel Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses |
Pharmacologic Actions Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on May 16, 2013