Status:
TERMINATED
MK-4827 in Combination With Pegylated Liposomal Doxorubicin in Participants With Advanced Solid Tumors and Ovarian Cancer (MK-4827-011)
Lead Sponsor:
Tesaro, Inc.
Conditions:
Ovarian Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This study will determine whether MK-4827 can be safely administered in combination with pegylated liposomal doxorubicin, and if so, will obtain an estimate of the benefit of the combination in patien...
Detailed Description
The decision to discontinue new enrollment is not related to any concerns about the safety profile of the product.
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01227941
Start Date
November 1 2010
End Date
September 1 2011
Last Update
October 19 2016
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