A Phase II Study of Cabazitaxel for Patients with Breast or Lung Cancer and Recurrent or Progressive Brain Metastases (CaBaMet)

Phase 1

• Conditions: breast or lung cancer with recurrent or progressive brain metastases; MedDRA version: 19.1Level: LLTClassification code 10025062Term: Lung cancer stage IVSystem Organ Class: 100000004864; MedDRA version: 19.1Level: LLTClassification code 10006192Term: Breast cancer NOSSystem Organ Class: 100000004864; MedDRA version: 19.1Level: LLTClassification code 10006128Term: Brain metastasesSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-005545-37-DE
• Lead Sponsor: AIO-Studien-gGmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12-23
• Last Update Posted: 18 April 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- Adult patients (= 18 years of age)
- Histologically or cytologically confirmed stage IV lung or breast cancer with progressive or recurrent brain metastases
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Prior external beam radiotherapy (WBRT or SRS) of BM. Patients suffering from small cell lung cancer (SCLC) who have been treated with chemotherapy and prophylactic cranial radiotherapy may be also enrolled.
- At least one two-dimensional measurable lesion on brain MRI
- Life expectancy at least 3 months
- Females of childbearing potential (FCBP) must have a negative pregnancy test within 7 days of the first application of study treatment
and must agree to use effective contraceptive birth control measures (Pearl Index < 1) during the course of the trial

A female subject is considered to be of childbearing potential unless she is age = 50 years and naturally amenorrhoeic for = 2 year, or unless she is surgically sterile.
- Males must agree to use effective contraception (Pearl Index < 1) during the course of the trial and for at least 6 months after last administration of study medication cabazitaxel. In addition males must agree to prevent contact with the ejaculate by another person throughout study treatment.

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

- Prior chemotherapy or targeted therapy (e.g. erlotinib, bevacizumab) for brain metastases
- Any chemotherapy or targeted tumor therapy within two weeks of study inclusion or concomitantly
- Any antihormonal tumor treatment within two weeks of study inclusion or concomitantly
- Time interval to prior external beam radiotherapy less than 2 weeks
- Suspected or known leptomeningeal disease
- Peripheral neuropathy = grade 2
- Inadequate organ and bone marrow function as evidenced by:
- Absolute neutrophil count (ANC) < 1.5 x 10*9/L
- Hemoglobin < 10.0 g/dL
- Platelet count < 100 x 10*9/L
- Total bilirubin = 1 x upper limit of normal (ULN)
- AST/GOT and/or ALT/GPT = 1.5 x ULN
- Serum creatinine > 1.5 x ULN. If creatinine 1.0 - 1.5 x ULN, creatinine clearance has to be calculated according to CKD-EPI formula and patients with creatinine clearance < 60 mL/min must be excluded
- Other inadequate organ function according to investigator’s discretion
- History of hypersensitivity reaction to docetaxel
- History of hypersensitivity reaction to polysorbate 80 containing drugs
- Uncontrolled severe illness or medical condition (including uncontrolled diabetes mellitus)
- Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5 (a one week wash-out period is necessary for patients who are already on these treatments; dexamethasone is allowed)
- Recently received or planned vaccination against yellow fever during study treatment
- Pregnant or breast feeding females
- Participation in any other clinical trial or treatment with any experimental drug within 28 day before enrolment to the study or during study participation until the end of treatment visit
- Previous or concurrent tumor other than underlying tumor disease (breast or lung cancer) with the exception of cervical cancer in situ, adequately treated basal cell carcinoma or squamous cell carcinoma of the skin, superficial bladder tumors (Ta,Tis, and T1) or any curatively treated tumors > 5 years prior to enrolment

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: Objective tumor response of brain metastases (BM);Secondary Objective: - To determine overall survival (OS)<br>- To determine progression-free survival (PFS) for BM<br>- To determine PFS for extracerebral tumor disease<br>- To determine time to treatment failure (TTF) of BM<br>- Quality of life<br>- Safety and tolerability<br>;Primary end point(s): Objective tumor response of BM (Complete response [CR] or partial response [PR] or at least a minor response [MR; 25-50% reduction] according to WHO criteria, and Iwamoto confirmed by magnetic resonance imaging [MRI]);Timepoint(s) of evaluation of this end point: every 6 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Efficacy variables:<br>- Median OS<br>- PFS for BM<br>- PFS for extracerebral tumor disease<br>- TTF of BM<br>- Quality of life, assessed with EORTC QLQ-C30 and additional modul BN20 questionnaire<br><br>Safety variables:<br>- Type, incidence and severity of adverse events<br>- Dose reduction or discontinuation of study drug cabazitaxel due to adverse events<br>;Timepoint(s) of evaluation of this end point: Q2/2017