Patients with advanced, metastatic, and recurrent carcinoma of the uterine cervix MedDRA version: 12.1 Level: LLT Classification code 10008229 Term: Cervical cancer
Conditions
Interventions
Product Name: MK-1775
Product Code: MK-1775
Pharmaceutical Form: Capsule*
INN or Proposed INN: MK-1775
Current Sponsor code: MK-1775
Concentration unit: mg milligram(s)
Concentration type: equal
Conce
Sponsors
Merck & Co., Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient must have a histologically or cytologically confirmed advanced, metastatic, and recurrent carcinoma of the uterine cervix (Stage II – IVb). 2. Patient must have received platinum in combination with radiation as initial or adjuvant treatment for their cervical cancer. 3. Patient may not have received any other treatment for their cancer following the chemo-radiation or targeted therapy with the exception of non-cytotoxic targeted therapy. 4. Recurrence must have occurred at least 6 months post platinum-based chemo-radiotherapy. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patient has had chemotherapy, radiotherapy, or biological therapy within 6 months prior to entering the study or who has not recovered from adverse events due to agents administered more than 6 months earlier. 2. Patient is currently participating or has participated in a study with an investigational compound or device within 28 days of receiving first dose of study medication. 3. Patients with active CNS metastases and/or carcinomatous meningitis are excluded. However, patients with CNS metastases who have completed a course of therapy would be eligible for the study provided they are clinically stable for 1 month prior to entry as defined as: (1) no evidence of new or enlarging CNS metastasis (2) off steroids or on a stable dose of steroids for at least 2 weeks. 4. Patient has had prescription or non-prescription drugs or other products (i.e. grapefruit juice) known to be metabolized by CYP3A4, or to inhibit or induce CYP3A4, which cannot be discontinued prior to Day 1 of dosing and withheld throughout the study until 2 weeks after the last dose of study medication.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Part 1 : (1) To determine the safety and tolerability of MK-1775 in combination with topotecan and cisplatin in patients with advanced, metastatic, and recurrent cervical cancer. (2) To establish a Phase II / Maximum Tolerated Dose for MK 1775 in combination with topotecan + cisplatin. (3) To determine the preliminary efficacy of MK-1775 in combination with topotecan and cisplatin in patients with advanced, metastatic, and recurrent cervical cancer. Part 2 : (1) To evaluate the effect of the combination of topotecan/cisplatin + MK-1775 versus topotecan/cisplatin alone on PFS in patients with advanced, metastatic, and recurrent cervical cancer. (2) To determine the safety and tolerability of MK-1775 in combination with topotecan and cisplatin in patients with advanced, metastatic, and recurrent cervical cancer. ;Secondary Objective: Part 1 : (1) To assess the pharmacokinetic profile of MK-1775 in combination with topotecan and cisplatin in patients with advanced, metastatic, and recurrent cervical cancer. (2) To determine pharmacodynamic changes in skin induced by MK-1775 in combination with topotecan and cisplatin in patients with advanced, metastatic, or recurrent cervical cancer. Part 2: (1) To evaluate the effect of the combination of topotecan/cisplatin + MK-1775 versus topotecan/cisplatin alone on OResponse Rate in patients with advanced, metastatic, and recurrent cervical cancer. (2) To evaluate the effect of the combination of topotecan/cisplatin + MK-1775 versus topotecan/cisplatin alone on Overall Survival in patients with advanced, metastatic, and recurrent cervical cancer.;Primary end point(s): Assessment of safety, efficacy, Progression Free Survival, pharmacokinetics, and the pharmacokinetic / pharmacodynamic relationship of MK1775 in combination with cisplatin/topotecan. | — |
Countries
France
Outcome results
None listed