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A Phase Ib Dose Escalation Study of MK-4827 in Combination With Pegylated Liposomal Doxorubicin (Doxil™ or Caelyx™) in Patients With Advanced Solid Tumors With a Cohort Expansion in Patients With Platinum Resistant/Refractory High Grade Serous Ovarian Cancer


Phase 1
18 Years
N/A
Not Enrolling
Both
Ovarian Cancer

Thank you

Trial Information

A Phase Ib Dose Escalation Study of MK-4827 in Combination With Pegylated Liposomal Doxorubicin (Doxil™ or Caelyx™) in Patients With Advanced Solid Tumors With a Cohort Expansion in Patients With Platinum Resistant/Refractory High Grade Serous Ovarian Cancer


The decision to discontinue new enrollment is not related to any concerns about the safety
profile of the product.


Inclusion Criteria:



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 Criteria:

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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants with Dose-limiting Toxicities (DLTs)

Outcome Time Frame:

28 days (one cycle of treatment)

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

MK-4827-011

NCT ID:

NCT01227941

Start Date:

November 2010

Completion Date:

September 2011

Related Keywords:

  • Ovarian Cancer
  • advanced solid tumors
  • ovarian cancer
  • pegylated liposomal doxorubicin
  • Doxil
  • Caelyx
  • Ovarian Neoplasms

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