A phase II study assessing safety and efficacy of Cabozantinib for advanced or metastatic cervical carcinoma after platinum treatment failure - CABOCOL-01

Centre François Baclesse0 sites57 target enrollmentOctober 18, 2019

ConditionsRecurrent unresectable or metastatic cervix carcinoma MedDRA version: 21.1Level: PTClassification code 10008344Term: Cervix carcinoma recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]

DrugsCABOZANTINIB

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Recurrent unresectable or metastatic cervix carcinoma
Sponsor: Centre François Baclesse
Enrollment: 57
Status: Active, not recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

October 18, 2019

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Investigators

Sponsor

Centre François Baclesse

Eligibility Criteria

Inclusion Criteria

•\-Female 18 years of age or older
•\-Histologically confirmed recurrent unresectable or metastatic cervix carcinoma
•\-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\.04\.0 (Common Terminology Criteria for Adverse Events, version 54\.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 randomizationinclusion:
•oAbsolute neutrophil count (ANC) \= 1000/mm3 (\= 1\.0 GI/L)
•oPlatelets \= 100,000/mm3 (\= 100 GI/L)
•oHemoglobin \= 10 g/dL (\= 100 g/L) (red blood cell transfusion is allowed)

Exclusion Criteria

•\-Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding and/or fistula/perforation including, but not limited to: Active peptic ulcer disease, inflammatory bowel disease (e.g. ulcerative colitis, Crohn's disease), history of abdominal fistula, gastrointestinal perforation, or intra\-abdominal abscess within 28 days prior to beginning study treatment.
•\-Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product including, but not limited to: malabsorption syndrome, major resection of the stomach or small bowel.
•\-History of any one or more of the following cardiovascular conditions within the past 6 months: Cardiac angioplasty or stenting, myocardial infarction, unstable angina, coronary artery bypass graft surgery, symptomatic peripheral vascular disease, class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA).
•\-Uncontrolled hypertension defined as systolic blood pressure (SBP) of \> 140 mmHg or diastolic blood pressure (DBP) of \> 90 mmHg despite an optimal treatment.
•\-History of cerebrovascular accident including transient ischemic attack (TIA), symptomatic pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months. Note: Subjects with recent DVT or asymptomatic pulmonary embolism who have been treated with therapeutic anti\-coagulating agents for at least 6 weeks are eligible.
•\-Major surgery or trauma within 28 days prior to first dose of investigational product and/or presence of any non\-healing wound, fracture, or ulcer.
•\-Evidence of active bleeding or pathologic conditions that carry high risk of bleeding such as known bleeding disorders, coagulopathy or tumor involving major vessels.
•\-Any external radiation therapy within 4 weeks before randomization.
•\-Presence of brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 3 months before randomization. Eligible subjects must be neurologically asymptomatic and without corticosteroid treatment at the time of randomization.
•\-Concomitant use of known strong CYP3A4 inhibitors or inducers.