A Study Comparing AZD-1775 (MK-1775) and Gemcitabine With Gemcitabine Alone in Ovarian, Peritoneal or Fallopian Tube Cancers
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Ovarian Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/16/2015 |
| Start Date: | July 2014 |
| End Date: | January 2017 |
| Contact: | Amit Oza, M.D. |
| Phone: | 416-946-2818 |
A Randomized Placebo-Controlled Phase II Trial Comparing Gemcitabine Monotherapy to Gemcitabine in Combination With AZD1775 (MK1775) in Women With Recurrent, Platinum Resistant Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancers
This is a phase 2 (the second phase in testing a new drug or drug combination, to see how
useful the drug or combination is) of chemotherapy drug, gemcitabine, when given alone or in
combination with investigational drug, AZD 1775 (also called MK-1775), in patients with
recurrent (the cancer has returned), platinum-resistant (the cancer does not respond to
platinum-based therapies) ovarian, peritoneal or fallopian tube cancers.
Gemcitabine is a chemotherapy drug commonly used to treat patients with recurrent,
platinumresistant ovarian, peritoneal or fallopian tube cancers. Gemcitabine works by
preventing tumor cells from multiplying by damaging their DNA, which in turn stops the tumor
from growing. However, a protein, called Wee1, may play a role in helping to repair damaged
tumor cells, so that the tumor continues to grow.
AZD 1775 (MK-1775) is a new drug which may block Wee1 protein activity. When given in
combination with gemcitabine, AZD 1775 (MK-1775) may help prevent the Wee1 protein from
repairing damaged tumor cells without causing harm to normal cells. This is believed to
increase the effectiveness of gemcitabine.
useful the drug or combination is) of chemotherapy drug, gemcitabine, when given alone or in
combination with investigational drug, AZD 1775 (also called MK-1775), in patients with
recurrent (the cancer has returned), platinum-resistant (the cancer does not respond to
platinum-based therapies) ovarian, peritoneal or fallopian tube cancers.
Gemcitabine is a chemotherapy drug commonly used to treat patients with recurrent,
platinumresistant ovarian, peritoneal or fallopian tube cancers. Gemcitabine works by
preventing tumor cells from multiplying by damaging their DNA, which in turn stops the tumor
from growing. However, a protein, called Wee1, may play a role in helping to repair damaged
tumor cells, so that the tumor continues to grow.
AZD 1775 (MK-1775) is a new drug which may block Wee1 protein activity. When given in
combination with gemcitabine, AZD 1775 (MK-1775) may help prevent the Wee1 protein from
repairing damaged tumor cells without causing harm to normal cells. This is believed to
increase the effectiveness of gemcitabine.
Inclusion Criteria:
- Measurable, platinum resistant/refractory epithelial ovarian, primary peritoneal or
fallopian-tube carcinoma
- Any number of prior lines of therapy
- Completed any prior chemotherapy, radiotherapy or major surgery at least 4 weeks
before receiving study treatment.
- Age 18 years or older on day of consent.
- ECOG performance status 2 or less
- Life expectancy greater than 3 months
- Normal organ and marrow function
- Can tolerate oral medication and no bowel obstruction
- Disease that is amenable to biopsy and willing to have biopsies
- Agree to contraception, not pregnant
- Understand and sign consent
Exclusion Criteria:
- Previously received gemcitabine for t recurrent disease
- Receiving other investigational agents
- Unstable brain metastases
- History of allergic reactions to AZD 1775 (MK-1775) or gemcitabine
- Receiving sensitive CYP3A4 substrates, CYP3A4 substrates with a narrow therapeutic
index, moderate to potent inhibitors / inducers of CYP3A4.
- Pregnant/breastfeeding
- HIV positive on combination antiretroviral therapy
- Uncontrolled intercurrent illness including, but not limited to, myocardial
infarction within 6 months, congestive heart failure, symptomatic congestive heart
failure, unstable angina pectoris, active cardiomyopathy, unstable ventricular
arrhythmia, uncontrolled hypertension, uncontrolled psychotic disorders, serious
infections, active peptic ulcer disease, active liver disease or cerebrovascular
disease with previous stroke, or psychiatric illness/social situations that would
limit compliance with study requirements
We found this trial at
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Fox Chase Cancer Center Fox Chase has earned the prestigious designation from the National Cancer...
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