CompletedPhase 2NCT01588821
Official study title

Cabozantinib in Advanced Solid Malignancies

Study summary

This research study is a Phase II clinical trial. Phase II clinical trials test the effectiveness of an investigational drug to learn whether the drug works in treating a specific cancer. "Investigational" means that the drug is still being studied and that research doctors are trying to find out more about it-such as the safest dose to use, the side effects it may cause, and if the drug is effective for treating different types of cancer. It also means that the FDA has not approved the drug for this type of cancer, or for any use outside of research studies. When cancer spreads from the primary tumor, one of the most commons sites it spreads to is bone. When cancer spreads to bone there can be significant symptoms such as pain. Cabozantinib works by blocking signaling that leads to cancer growth as well as blocking the growth of new blood vessels (angiogenesis) that help to feed a tumor. Cabozantinib has been studied or is being studied in research studies as a possible treatment for various types of cancer, including prostate cancer, brain cancer, thyroid cancer, lung cancer and kidney cancer. Previous clinical research studies indicate that cabozantinib may also have activity against cancer once it has spread to the bones. The purpose of this study is to find out if cabozantinib is effective in treating cancer that has spread to the bone.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedCabozantinib

The study team can explain what participation involves.

Who it may be forLung Cancer · Solid Tumor (Not Breast or Prostate Cancers)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Sep 29, 2020 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Massachusetts General Hospital

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Massachusetts General Hospital
Interventions being studied
Drug: Cabozantinib
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • Histologic or cytologic diagnosis of a solid tumor (not breast or prostate) that is metastatic and refractory to or progressed following standard therapies
  • Has bony metastases
  • Agree to use medically accepted methods of contraception
Reasons someone may not be able to joinExclusion criteria
  • Pregnant or breastfeeding
  • Received cytotoxic chemotherapy (including investigational cytotoxic chemotherapy) or biologic agents within 3 weeks of study entry(6 weeks for nitrosoureas/mitomycin C)
  • Received radiation to the thoracic cavity/GI tract (within 3 months of study entry), to bone or brain metastasis (within 14 days) or to any other site within 28 days
  • Received prior treatment with small molecule kinase inhibitor or hormonal therapy within 14 days/5 half-lives
  • Received therapy with another investigational agent within past 28 days
  • Has not recovered from toxicities due to prior therapies
  • Primary brain tumor
  • Active brain metastases or epidural disease
  • Uncontrolled significant intercurrent or recent illness
  • Allergy or hypersensitivity to components of the study treatment formulation

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Massachusetts General HospitalBoston, Massachusetts

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 29, 2020. Always confirm current availability with the study team.

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