Clinical trial · Interventional
A Study of MK-4827 in Combination With Standard Chemotherapy in Participants With Advanced Solid Tumors (MK-4827-008 AM1)
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
NCT01110603CI-TRIAL-00022022terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer: Solid Tumors | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboplatin | Drug | Carboplatin | ALIAS |
| liposomal doxorubicin | Drug | — | UNRESOLVED |
| MK-4827 | Drug | Niraparib | ALIAS |
| paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- MK-4827 + carboplatin
- interventionNames
- Drug: MK-4827
- Drug: carboplatin
- type
- EXPERIMENTAL
- label
- MK-4827 + carboplatin/paclitaxel
- interventionNames
- Drug: MK-4827
- Drug: carboplatin
- Drug: paclitaxel
- type
- EXPERIMENTAL
- label
- MK-4827 + carboplatin/liposomal doxorubicin
- interventionNames
- Drug: MK-4827
- Drug: carboplatin
- Drug: liposomal doxorubicin
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.