Cabozantinib in Advanced Solid Malignancies

NCT01588821 | Completed Phase 2 Results DMC

• 1 other identifier: 12-091
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Cancer; Solid Tumor (Not Breast or Prostate Cancers)

Keywords

Metastatic; Refractory; Relapsed

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Bone Bio-marker Response

  Effect of cabozantinib on bone biomarkers of osteoblast and osteoclast activity. The bio-markers of interest were serum C-terminal telopeptide (Ctx), urine N-terminal telopeptide (Ntx), serum (Ntx). Participants were considered to have a response if there was at least a 40% decrease in the bio-marker concentration.

  8 Weeks

Secondary Outcomes (6)

• Number of Patients With Skeletal-related Events (SRE)

  2 years

• Quality of Life as Assessed by FACT-G

  From baseline to Cycle 3 Day 1 (approximately 2 months)

• Overall Tumor Response Rate

  2 years

• MET Amplification in Tumor Sample

  2 years

• Response to Cabozantinib in Bone Metastatic Disease

  2 years

Study Arms (1)

Treatment Arm

EXPERIMENTAL

Cabozantinib

Drug: Cabozantinib

Interventions

Cabozantinib DRUG

60 mg daily by mouth

Also known as: XL184

Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Prostatic Neoplasms; Neoplasm Metastasis; Recurrence

Interventions

cabozantinib

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Results Point of Contact

• Title: Rebecca Suk Heist, MD
• Organization: Massachusetts General Hospital

rheist@partners.org

617-724-4000

Study Officials

• Rebecca Heist, MD

  MGH

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 26, 2012
• First Posted: May 1, 2012
• Study Start: June 1, 2012
• Primary Completion: January 1, 2017
• Study Completion: June 1, 2019
• Last Updated: September 29, 2020
• Results First Posted: January 10, 2018

Record last verified: 2020-09

Locations

US (1)