Health TrialsbyHealthPanel

Cabozantinib for Patients With Recurrent or Progressive Meningioma

ConditionMeningioma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBaptist Health South Florida

About this trial

A Phase II Study of Cabozantinib for Patients with Recurrent or Progressive Meningioma

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologic (preferred) or radiologic diagnosis of meningioma. All World Health Organization (WHO) grades (I, II and III) are allowed.

All patients must have developed recurrent disease or progressive disease after receiving standard therapy (e.g., radiation or surgery) > 6 months ago or have been deemed ineligible to receive these therapies.

Karnofsky Performance Status ≥ 50.

Absolute Neutrophil Count ≥ 1.5 × 10^9 / L without granulocyte colony-stimulating factor support.

Disqualifiers

Prior treatment with cabozantinib.

Patients < 18 years old.

Patients who are pregnant or breast-feeding.

4. Any other active malignancy at time of first dose of study treatment or diagnosis of another malignancy within 3 years prior to first dose of study treatment that requires active treatment, except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.

Trial design

Design model

Single group

Treatments tested in this trial

  • Cabozantinib

    Drug

    Cabozantinib tablets are supplied as film coated tablets containing cabozantinib malate equivalent to 20 mg and 60 mg of cabozantinib and contain microcrystalline cellulose, lactose anhydrous, hydroxypropyl cellulose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate and Opadry® yellow. The 60 mg tablets are oval and the 20 mg tablets are round. Doses of 40 mg will comprise two 20-mg tablets. The starting dose for all participants is 60 mg per day by mouth. The study doctor may reduce a participant's dose to 40 mg per day, 20 mg per day, or 20 mg every other day depending on severity of side effects. The study doctor may also increase the dose back up to 60 mg per day if side effects improve.

Treatment groups

24 Participants
are divided into 1 treatment group
Group A: CabozantinibExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Progression free survival (PFS)

PFS is defined as the proportion of participants who from the start of treatment are free from objective tumor progression or death from any cause at 6 months. Tumor response and progression will be assessed using Response Assessment in Neuro-Oncology (RANO) meningioma criteria. Progressive disease (PD) is defined as the presence of any of the following criteria: ≥ 25% increase in target lesion area relative to nadir, unequivocal progression of any nontarget lesion, presence of new lesions, or worsening clinical status. Participants without documented progression or death by 6 months will be censored at the date of their last adequate disease assessment. Those who discontinue early or are lost to follow-up prior to 6 months without a progression event will be censored at their last tumor assessment. Suspected but unconfirmed progression will not be counted as an event unless subsequently confirmed.

Time frame
6 months

Secondary outcomes

1

Objective response rate (ORR)

ORR is defined as the proportion of participants with confirmed complete response (CR) or partial response (PR) assessed by RANO meningioma criteria, from the start of treatment to two years. CR is defined as the disappearance of all target and non-target lesions, no new lesions, no use of corticosteroids, and stable or improved clinical status. PR is defined as ≥ 50% decrease in target lesion area relative to baseline, stable or improved non-target lesions, no new lesions, stable or decreased use of corticosteroids, and stable or improved clinical status.

Time frame
2 years
2

Overall survival (OS)

Overall Survival (OS): duration of time from start of treatment until death from any cause. Patients lost-to follow up will be censored at last valid assessment.

Time frame
2 years
3

Percent of participants with adverse events (AEs)

Percent of participants who develop AEs as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 criteria.

Time frame
2 years
4

Percent of participants with Grade 3-5 AEs

Percent of participants who develop Grade 3-5 AEs as assessed by CTCAE v5.0 criteria.

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Baptist Health South Florida

Lead sponsor

Exelixis

Collaborator

Source ClinicalTrials.gov
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