A Study of MK-1775 in Combination With Topotecan/Cisplatin in Participants With Cervical Cancer (MK-1775-008)
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ClinicalTrials.gov Identifier: NCT01076400 |
Recruitment Status :
Terminated
(The sponsor permanently suspended new enrollment into the trial and discontinued the study; which was not related to any concerns over product safety.)
First Posted : February 26, 2010
Results First Posted : December 14, 2017
Last Update Posted : July 20, 2018
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Condition or disease | Intervention/treatment | Phase |
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Cervical Cancer | Drug: MK-1775 Drug: Topotecan Drug: Cisplatin Drug: Placebo to MK-1775 | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 7 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Two Part, Phase I-IIa Study Evaluating MK1775 in Combination With Topotecan/Cisplatin in Adult Patients With Cervical Cancer |
Actual Study Start Date : | May 31, 2010 |
Actual Primary Completion Date : | June 13, 2011 |
Actual Study Completion Date : | June 13, 2011 |

Arm | Intervention/treatment |
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Experimental: Part 1: MK-1775 + topotecan/cisplatin
Part 1: Dose escalation study. MK-1775 capsules will be administered in sequentially rising dose levels twice daily for a total of nine doses on Days 1-5 of a 21-day cycle. Topotecan will be administered at a dosage of 0.75 mg/m^2 by intravenous (IV) infusion over 30 minutes on Days 1-3 . Cisplatin will be administered at a dosage of 50 mg/m^2 by IV infusion over 30 minutes on Day 1.
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Drug: MK-1775
MK-1775 capsules are administered in sequentially rising dose levels twice daily for a total of nine doses on Days 1-5 of a 21-day cycle. Drug: Topotecan Topotecan is administered at a dosage of 0.75 mg/m^2 by intravenous (IV) infusion over 30 minutes on Days 1-3. Drug: Cisplatin Cisplatin is administered at a dosage of 50 mg/m^2 by IV infusion over 30 minutes on Day 1. |
Experimental: Part 2: MK-1775 + topotecan/cisplatin
Part 2: MK-1775 capsules will be administered at the dose determined in Part 1 twice daily for a total of nine doses on Days 1-5 of a 21-day cycle. Topotecan will be administered at a dosage of 0.75 mg/m^2 by intravenous (IV) infusion over 30 minutes on Days 1-3. Cisplatin will be administered at a dosage of 50 mg/m^2 by IV infusion over 30 minutes on Day 1.
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Drug: MK-1775
MK-1775 capsules are administered in sequentially rising dose levels twice daily for a total of nine doses on Days 1-5 of a 21-day cycle. Drug: Topotecan Topotecan is administered at a dosage of 0.75 mg/m^2 by intravenous (IV) infusion over 30 minutes on Days 1-3. Drug: Cisplatin Cisplatin is administered at a dosage of 50 mg/m^2 by IV infusion over 30 minutes on Day 1. |
Placebo Comparator: Part 2: Placebo to MK-1775 + topotecan/cisplatin
Part 2: Placebo to MK-1775 capsules will be administered twice daily for a total of nine doses on Days 1-5 of a 21-day cycle. Topotecan will be administered at a dosage of 0.75 mg/m^2 by intravenous (IV) infusion over 30 minutes on Days 1-3. Cisplatin will be administered at a dosage of 50 mg/m^2 by IV infusion over 30 minutes on Day 1.
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Drug: Topotecan
Topotecan is administered at a dosage of 0.75 mg/m^2 by intravenous (IV) infusion over 30 minutes on Days 1-3. Drug: Cisplatin Cisplatin is administered at a dosage of 50 mg/m^2 by IV infusion over 30 minutes on Day 1. Drug: Placebo to MK-1775 Placebo to MK-1775 capsules are administered in sequentially rising dose levels twice daily for a total of nine doses on Days 1-5 of a 21-day cycle. |
- Part 1: Percentage of Participants Whose Best Confirmed Response is Partial Response (PR) or Complete Response (CR) [ Time Frame: Up to approximately 1 year ]On the basis of Response Evaluation Criteria In Solid Tumors (RECIST) 1.1, PR is at least a 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline sum diameters. CR is the disappearance of all extranodal target lesions, where all pathological lymph nodes must have decreased to <10 mm in the short axis.
- Part 1: Number of Participants With Dose Limiting Toxicities (DLTs) [ Time Frame: Up to approximately 1 year ]A DLT is a protocol-defined, (hematologic and non-hematologic), AE that must be definitely, probably, or possibly related to the study therapy. A DLT is any of the following: Grade 4-5 hematological toxicity; Grade 3 or Grade 4 neutropenia with fever >38.°C and/or infection requiring antibiotic or anti-fungal treatment. Non-hematologic dose-limiting toxicities are any Grade 3, 4, or 5 non-hematologic toxicity, with specific exceptions. If occurring within the first cycle of combination therapy: unresolved drug-related toxicity, preventing (re) treatment for 3 weeks or more from the date of the next scheduled treatment or any drug-related toxicity preventing the participant from taking at least 75% of the doses of MK-1775 with each administration of chemotherapy.
- Part 2: Length of Time for Progression-free Survival (PFS) [ Time Frame: Up to approximately 1 year ]PFS is the length of time during and after treatment that a participant lives, but whose tumor progression does not worsen. PFS is defined as the time from randomization to progressive disease or death, whichever occurs earlier. Tumor volume changes of +20% for progressive disease was used to be consistent with RECIST 1.1.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Gender Based Eligibility: | Yes |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Has advanced, metastatic, and recurrent squamous cell, adenosquamous, or adeno-carcinoma of the uterine cervix (Stage II - IVb)
- Has received cisplatin in combination with radiation as initial or adjuvant treatment for their cervical cancer
- Has not received any other treatment for their cancer following the cisplatin-based chemo-radiation or targeted therapy except non-cytotoxic targeted therapy
- Recurrence must be at least 6 months post cisplatin-based chemotherapy
- Has measurable disease
- Performance status on the Eastern Cooperative Oncology Group (ECOG) Performance Scale is less than or equal to 1
- Has a negative pregnancy test within 72 hours of the first dose of study medication
Exclusion Criteria:
- Has had chemotherapy, radiotherapy, or biological therapy within 6 months of entering the study
- Has a history of vascular thrombotic events or vascular reconstruction
- Has active central nervous system (CNS) metastases and/or carcinomatous meningitis
- Has a primary CNS tumor
- Requires the use of medications or products that are metabolized by, or inhibit or induce CYP3A4 (Cytochrome P450 3A4)
- Is expecting to reproduce within the duration of the study or is pregnant or breastfeeding
- Is known to be Human Immunodeficiency Virus (HIV)-positive
- Has known active Hepatitis B or C
- Has a known history of interstitial lung disease or pulmonary fibrosis
- Has symptomatic ascites or pleural effusion
- Has a clinical history suggestive of Li-Fraumeni Syndrome

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01076400
Study Director: | Medical Director | Merck Sharp & Dohme LLC |
Responsible Party: | Merck Sharp & Dohme LLC |
ClinicalTrials.gov Identifier: | NCT01076400 |
Other Study ID Numbers: |
1775-008 2009-017054-12 ( EudraCT Number ) MK-1775-008 ( Other Identifier: Merck Protocol Number ) |
First Posted: | February 26, 2010 Key Record Dates |
Results First Posted: | December 14, 2017 |
Last Update Posted: | July 20, 2018 |
Last Verified: | July 2018 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Uterine Cervical Neoplasms Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms Uterine Cervical Diseases Uterine Diseases |
Topotecan Adavosertib Antineoplastic Agents Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |