A Phase II Study of Cabozantinib (XL184) Therapy in Castrate Resistant Prostate Cancer (CRPC) With Visceral Metastases

NCT01834651 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: XL184-IST20
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

This research study is being done to measure the clinical benefit associated with cabozantinib (XL184) in men who have prostate cancer that has spread to visceral organs (organs other than bone or lymph nodes) and no longer responds to initial hormonal (castration) therapy. This type of prostate cancer is called metastatic, castrate-resistant prostate cancer.

Conditions

Prostate Cancer

Keywords

liver metastasis; lung metastasis; metastatic castrate-resistant; prostate cancer

Outcome Measures

Primary Outcomes (1)

• Clinical Benefit Rate From Cabozantinib (XL184)

  Clinical benefit rate is defined as the combination of complete response, partial response, and stable disease as defined by modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by CT imaging and Prostate Cancer Working Group 2 (PCWG2) criteria. Complete response (CR) defined as disappearance of all target lesions; Partial response (PR) \>=30% decrease in som of diameters of target lesions (taking as reference the baseline), and stable disease, neither sufficient shrinkage to qualify for PR nor increase to qualify for progressive disease.

  Baseline to 12 weeks after starting therapy

Secondary Outcomes (5)

• Change in Number of Circulating Tumor Cells (CTC) in Response to Cabozantinib

  Baseline and 12 weeks

• Number of Patients With NanoVelcro Appropriate for RNA in Circulating Tumor Cells

  12 weeks

• Change in Levels of Serum Hepatocyte Growth Factor (HGF) and Vascular Endothelial Growth Factor (VEGF) Concentration

  12 weeks

• Number of Participants With Grade 3/4 Adverse Events Related to Cabozantinib as Assessed Using CTCAE (v.4)

  Every 2 weeks for first 3 Cycles and every 4 weeks thereafter for an expected average of 28 weeks.

• Number of Patients With Evaluable Protein Content of Large Oncosomes From Baseline to First Documented Progression or Date of Death

  From baseline until the date of first documented progression or date of death from any cause, whichever comes first, assessed for an expected average of 28 weeks.

Study Arms (1)

Treatment (cabozantinib)

EXPERIMENTAL

Cabozantinib 60mg orally daily until disease progression

Drug: Cabozantinib

Interventions

Cabozantinib DRUG

Cabozantinib 60 mg daily (oral). Subjects may continue to receive study treatment until they experience unacceptable drug-related toxicity or disease progression.

Also known as: XL184

Treatment (cabozantinib)

Eligibility Criteria

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

You may qualify if:

• \- mCRPC that includes visceral disease. Visceral metastatic disease is defined as solid organ infiltration that is not bone or lymph node metastases.

You may not qualify if:

• Recent history (\<6 months) of gastrointestinal hemorrhage requiring blood transfusion.
• Tumor involvement in the intestinal lining which the treating physician deems at risk for perforation with rapid tumor response.

Sponsors & Collaborators

• Edwin Posadas, MD: lead

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

cabozantinib

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Dr. Edwin Posadas
• Organization: Cedars-Sinai Medical Center

Edwin.Posadas@cshs.org

310-423-7600

Study Officials

• Edwin Posadas, MD FACP

  Cedars-Sinai Medical Center Samuel Oschin Comprehensive Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Director, Urologic Oncology Program

Study Record Dates

• First Submitted: April 1, 2013
• First Posted: April 18, 2013
• Study Start: April 30, 2013
• Primary Completion: July 18, 2016
• Study Completion: July 18, 2016
• Last Updated: September 27, 2017
• Results First Posted: September 27, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)