Phase 2
N=25
Cabozantinib-S-Malate in Treating Patients With Refractory Thyroid Cancer
Poorly Differentiated Thyroid Gland Carcinoma · Recurrent Thyroid Gland Carcinoma · Stage I Thyroid Gland Follicular Carcinoma · Stage I Thyroid Gland Papillary Carcinoma · Stage II Thyroid Gland Follicular Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT01811212 ↗Enrolled (actual)
25
Serious AEs
28.0%
Results posted
Apr 2018
Primary outcome: Primary: Objective Response Rate, Defined as the Proportion of Patients Who Have Had a PR or CR as Assessed by the RECIST Version (v)1.1 — 10 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Cabozantinib S-malate (Drug); Laboratory Biomarker Analysis (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Cancer Institute (NCI)
- Primary completion
- Jul 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate, Defined as the Proportion of Patients Who Have Had a PR or CR as Assessed by the RECIST Version (v)1.1 |
10 | — |
| SECONDARY Bone Turnover, as Measured by Serum and Urinary Markers of Bone Turnover |
— | — |
| SECONDARY Duration of Objective Response as Assessed by the RECIST v1.1 |
11.3 | — |
| SECONDARY Expression Levels of Predictive Biomarkers of Response by Immunohistochemistry in Archived Tumor Tissue |
— | — |
| SECONDARY Genotype of Biomarkers Potentially Predictive of Response |
— | — |
| SECONDARY Incidence of Severe (Grade 3+) Adverse Events, Graded According to the National Cancer Institute CTCAE v4.0 |
1; 1; 1; 1; 1; 1 | — |
| SECONDARY Overall Survival |
34.7 | — |
| SECONDARY Percent Change in Serum Tumor Marker Thyroglobulin Levels |
— | — |
| SECONDARY Progression-free Survival |
12.7 | — |
| SECONDARY Response of Cabozantinib-s-malate in Bone Metastasis (Bone Metastasis-specific Progression Free Survival) as Evaluated by Functional Imaging |
— | — |
Summary
This phase II trial studies how well cabozantinib-s-malate works in treating patients with thyroid cancer that does not respond to treatment. Cabozantinib-s-malate may stop the growth of thyroid cancer by blocking some of the enzymes needed for cell growth. Cabozantinib-s-malate may also stop the growth of thyroid cancer by blocking blood flow to the tumor.
Eligibility Criteria
Inclusion Criteria
- Patients must have histologically or cytologically confirmed papillary thyroid cancer, follicular thyroid cancer or hurthle cell thyroid cancer (cancer, follicular variant of papillary thyroid cancers or any of the above mixed histology will be allowed; these patients will be enrolled on Arm A of the trial); patients with the following aggressive histologies will be enrolled on Arm B of the trial; tall cell, insular or poorly differentiated thyroid cancer
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 2.0 cm with conventional techniques or as >= 1.0 cm (or >= 1.5 cm in short axis for lymph node) with spiral computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam
- Patients must have radioactive iodine (RAI)-refractory/resistant disease as defined by one or more of the following criteria:
- One or more measurable lesions that do not demonstrate RAI uptake
- One or more measurable lesions progressive by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 within 12 months of prior RAI therapy
- One or more measurable lesion present after cumulative RAI dose of >= 600 mCi
- Patients must have "progressed on" up to 2 lines of prior vascular endothelial growth factor receptor (VEGFR)-targeted therapy (including but not limited to sorafenib, sunitinib, vandetanib, pazopanib, or lenvatinib) as defined by progressive disease per RECIST while receiving VEGFR-targeted therapy; Note: patients who progressed on kinase inhibitor that target VEGFR and MET will not be eligible
- Prior external beam radiation, systemic cytotoxic chemotherapy or BRAF- or non-VEGFR-targeted therapies will be allowed, provided that >= 4 weeks has elapsed since receiving prior treatment and they have recovered to = = 1,500/mcL
- Platelet count >= 100,000/mcL
- Hemoglobin >= 9 g/dL
- Thyroid stimulating hormone (TSH) = 2.8 g/dL
- Lipase = LLN
- Prothrombin time (PT) = 12 consecutive months; Note: women who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, antiestrogens, ovarian suppression or any other reversible reason
- Women of child-bearing potential and men must agree to use adequate contraception; women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of cabozantinib administration; sexually active subjects (men and women) must agree to use medically accepted barrier methods of contraception (e.g., male or female condom) during the course of the study and for 4 months after the last dose of study drug(s), even if oral contraceptives are also used; all subjects of reproductive potential must agree to use both a barrier method and a second method of birth control during the course of the study and for 4 months after the last dose of study drug(s)
- Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria
- Prior treatment with cabozantinib or any tyrosine kinase inhibitor that targets MET or monoclonal antibody (mAb) targeting MET (such as onartuzumab [MetMAb])
- The subject has received radionuclide treatment = = 0.5 teaspoon (2.5 mL) of red blood = 140 mmHg systolic, or > 90 mmHg diastolic despite optimal antihypertensive treatment = 480 ms within 28 days before registration; Note: if initial QTcF or QTcB is found to be > 480 ms, two
Data sourced from ClinicalTrials.gov (NCT01811212). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.