Clinical trial · Interventional
A Study of Adavosertib (MK-1775) in Combination With Topotecan/Cisplatin in Participants With Cervical Cancer (MK-1775-008)
A Two Part, Phase I-IIa Study Evaluating MK1775 in Combination With Topotecan/Cisplatin in Adult Patients With Cervical Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The sponsor permanently suspended new enrollment into the trial and discontinued the study; which was not related to any concerns over product safety.
Summary
Brief summary (as posted)
This study will be conducted in two parts. Part 1 will determine whether administration of adavosertib in combination with topotecan and cisplatin is generally well-tolerated and causes clinical objective responses in patients with cervical cancer. Part 1 will also define the recommended Phase 2 dose and maximum tolerated dose (MTD) of the combination of adavosertib with topotecan and cisplatin. Part 2 of the study will evaluate whether treatment with adavosertib in combination with topotecan and cisplatin causes an improvement in progression-free survival (PFS) compared to treatment with topotecan and cisplatin alone and will further evaluate the tolerability of the combination treatment. The primary hypothesis is the combination of adavosertib, topotecan and cisplatin causes objective radiological responses (assessed per Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1 criteria) in ≥30% of participants. Due to the early termination of the study by the sponsor, no participants were enrolled in Part 2 of the study.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adavosertib | Drug | Adavosertib | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Placebo to adavosertib | Drug | — | UNRESOLVED |
| Topotecan | Drug | Topotecan | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Part 1: adavosertib + topotecan/cisplatin
- description
- Part 1: Dose escalation study. adavosertib 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.
- interventionNames
- Drug: adavosertib
- Drug: Topotecan
- Drug: Cisplatin
- type
- EXPERIMENTAL
- label
- Part 2: adavosertib + topotecan/cisplatin
- description
- Part 2: adavosertib 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.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available