Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Tesaro, Inc.
The decision to discontinue new enrollment is not related to any concerns about the safety profile of the product.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Parts A and B:
The participant has a locally advanced or metastatic solid tumor and lacks curative options
* Pegylated liposomal doxorubicin must be an appropriate therapy or the participant has not responded to standard of care or therapies known to provide clinical benefit, or has refused such therapies or no therapy is known to provide clinical benefit
Part B only: Female participants must have high grade serous ovarian cancer without curative options; pegylated liposomal doxorubicin must be an appropriate therapy. Eligible patients for Part B must have:
* Platinum-resistant ovarian cancer, defined as tumor progression within 6 months of completing treatment with a platinum-containing agent, OR secondary platinum-refractory ovarian cancer defined as tumor progression while on treatment for recurrent ovarian cancer after initially responding to a platinum-based chemotherapy regimen in the first line setting; and
* Measurable disease, OR elevated serum cancer antigen 125 (CA-125) levels at baseline, defined as a pre-treatment sample that is at least twice the upper limit of normal and within 2 weeks prior to starting treatment
* Participant has a performance status of 0 or 1 on the ECOG (Eastern Cooperative Oncology Group) Performance Scale
* Participant must have adequate organ function
* Participant has no history of a prior malignancy with the exception of cervical intraepithelial neoplasia, basal cell carcinoma of the skin, or has undergone potentially curative therapy with no evidence of that disease for five years, or is deemed at low risk for recurrence by his/her treating physician
You may not be if
Parts A and B:
The participant:
Has had chemotherapy, radiotherapy, or biological therapy within 4 weeks of entering the study
Has previously been treated with pegylated liposomal doxorubicin
Has active central nervous system metastases or a primary central nervous system tumor
Part A: Has had more than two prior chemotherapy regimens; in Part B, there is no limit to the number of prior chemotherapy regimens
Is known to be Human Immunodeficiency Virus (HIV) positive
Has a known history of Hepatitis B or C
Has a left ventricular ejection fraction (LVEF) below the institutional lower limit of normal
Has had prior doxorubicin exposure \>240 mg/m\^2 (or anthracycline equivalent)
Has initiated or adjusted bisphosphonate therapy/regimen within 30 days prior to Cycle 1 Day 1
Part B only: Has been previously treated with a poly\[ADP\] ribose polymerase (PARP) inhibitor
Clareo Health | MK-4827 in Combination With Pegylated Liposomal Doxorubicin in Participants With Advanced Solid Tumors and Ovarian Cancer (MK-4827-011)
