A Two Part, Phase I-IIa Study Evaluating MK-1775 in Combination With Topotecan/Cisplatin in Adult Patients With Cervical Cancer

Phase 1

• Conditions: Patients with advanced, metastatic, and recurrent carcinoma of the uterine cervix; MedDRA version: 12.1Level: LLTClassification code 10008229Term: Cervical cancer

• Registration Number: EUCTR2009-017054-12-FR
• Lead Sponsor: Merck & Co., Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-02-22
• Study Completion: 2011-06-13
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 132

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified