Phase 1
Completed N=36
Cabozantinib S-Malate in Treating Patients With Advanced Solid Tumors and Human Immunodeficiency Virus
Advanced Malignant Solid Neoplasm · HIV · Metastatic Malignant Solid Neoplasm · Recurrent Malignant Solid Neoplasm
Source: ClinicalTrials.gov NCT01822522 ↗
Enrolled (actual)
36
Serious AEs
41.7%
Results posted
Jan 2023
Primary outcomePrimary: Incidence of Adverse Events — 6; 7; 7; 6 Participants
Summary
This phase I trial studies the side effects and best dose of cabozantinib s-malate in treating patients with solid tumors that have spread to other places in the body and usually cannot be cured or controlled with treatment and human immunodeficiency virus. Cabozantinib s-malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Adverse Events |
6; 7; 7; 6; 3; 7 | — |
| PRIMARY Maximal Tolerated Dose (MTD) of Cabozantinib-s-malate |
20; 60; 60 | — |
| SECONDARY Response Rates |
0; 0; 1; 2; 0; 2 | — |
| SECONDARY Human Immunodeficiency Virus (HIV) Viral Load |
3; 4; 2; 3; 1; 4 | — |
| SECONDARY CD4+ Cell Counts |
41.0; 30.0; 64.5; 23.0; 33.0; -87.5 | — |
| SECONDARY CD8+ Cell Counts |
— | — |
| SECONDARY Pharmacokinetic Parameters |
683; 521; 1239 | — |
Eligibility Criteria
Inclusion Criteria
- Participants must have known HIV infection and histologically confirmed solid malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective; any number of prior cancer therapies will be permitted; at least 4 weeks must have elapsed since prior chemotherapy or biological therapy, 6 weeks if the regimen included carmustine (BCNU) or mitomycin C; prior radiation therapy to the thoracic cavity, abdomen, or pelvis must be completed at least 3 months prior to registration; radiotherapy to any other site (including bone or brain metastases) must be completed at least 28 days prior to registration
- Serologic documentation of HIV infection at any time prior to study entry, as evidenced by positive enzyme-linked immunosorbent assay (ELISA), positive western blot, or any other federally approved licensed HIV test; alternatively, this documentation may include a record that another physician has documented that the participant has HIV infection based on prior ELISA and western blot, or other approved diagnostic tests
- Eastern Cooperative Oncology Group (ECOG) performance status = = 60%)
- Life expectancy of greater than 12 weeks
- Leukocytes >= 3, 000/mcL (within 1 week of study entry)
- Absolute neutrophil count >= 1, 500/mcL (within 1 week of study entry)
- Platelets >= 100, 000/mcL (within 1 week of study entry)
- Total bilirubin= = 50 mL/min/1.73 m^2 for participants with creatinine levels above institutional normal (within 1 week of study entry)
- Hemoglobin >= 9 g/dL (within 1 week of study entry)
- Serum albumin >= 2.8 g/dL (within 1 week of study entry)
- Lipase = lower limit of normal (LLN) (within 1 week of study entry)
- Calcium >= LLN (within 1 week of study entry)
- Magnesium >= LLN (within 1 week of study entry)
- Potassium >= LLN (within 1 week of study entry)
- A cluster of differentiation (CD)4+ lymphocyte count > 50/mcL will be required within 2 weeks of study participation
- Women of childbearing potential must have a negative pregnancy test within 7 days before enrollment; women of childbearing potential include women who have experienced menarche and who have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or are not postmenopausal; postmenopause is defined as amenorrhea >= 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
- The effects of cabozantinib on the developing human fetus are unknown; for this reason and because tyrosine kinase inhibitors agents as well as other therapeutic agents used in this trial are known to be teratogenic, 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 6 months after completion of cabozantinib administration; sexually active participants (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 6 months after the last dose of study drug(s), even if oral contraceptives are also used; all participants 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 6 months after the last dose of study drug
- Participating participants MUST receive appropriate care and treatment for HIV infection, including antiretroviral medications
Data sourced from ClinicalTrials.gov (NCT01822522). 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. Informational only — not medical advice.