Cabozantinib for Advanced or Metastatic Cervical Carcinoma After Platinum Treatment Failure (NCT04205799) | Clinical Trial Compass
CompletedPhase 2
Cabozantinib for Advanced or Metastatic Cervical Carcinoma After Platinum Treatment Failure
France57 participantsStarted 2020-01-15
Plain-language summary
Assess efficacy and safety of cabozantinib in monotherapy in advanced/metastatic cervical cancer (CC) after failure of platinum-based regimen treatment.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Female 18 years of age or older
* Histologically confirmed recurrent unresectable or metastatic cervix carcinoma with squamous cell, adenocarcinoma or adenosquamous histology - - Patient may have received at least one prior chemotherapy regimen of platinum-based chemotherapy for recurrence or metastatic disease.
* Cisplatin given in combination with radiation for a localized disease does not count as a prior chemotherapy.
* Prior treatment for advanced/metastatic disease with bevacizumab is allowed.
* Prior treatments with immune checkpoint inhibitors are allowed. - ECOG performance status 0-2 - Measurable disease per RECIST 1.1
* The subject must have recovered to baseline or CTCAE v.5.0 (Common Terminology Criteria for Adverse Events, version 5.0) ≤ Grade 1 from clinical toxicities related to any prior treatments, i.e chemotherapy or pelvis radiation unless AE(s) are clinically non-significant (for example alopecia)
* Adequate organ and marrow function, defined as follows, based upon laboratory tests performed within 7 days before inclusion:
* Absolute neutrophil count (ANC) ≥ 1000/mm3 (≥ 1.0 GI/L)
* Platelets ≥ 100,000/mm3 (≥ 100 GI/L)
* Hemoglobin ≥ 10 g/dL (≥ 100 g/L) (red blood cell transfusion is allowed)
* Total bilirubin ≤ 1.5 fold the upper limit of normal (for subjects with Gilbert's disease, ≤ 3 mg/dL or ≤ 51.3 μmol/L) o Serum albumin ≥ 3.0 g/dL (≥ 30 g/L)
* Calculated creatinine clearance ≥ 30 mL/min by the CKD-EPI method.
* Al…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Efficacy of Cabozantinib: Proportion of Patients With Disease Control Rate
Timeframe: 3 months after cabozantinib treatment initiation.
2
Safety of Cabozantinib: Proportion of Patients With Clinical Gastro-intestinal (GI) Perforation/Fistula, GI-vaginal Fistula and Genito-urinary (GU) Fistula Events Grade ≥ 2 (NCI CTCAE v 5.0)
Timeframe: toxicities occurring up to 1 month after the end of treatment