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Adenocarcinoma of the ProstateNCT01812668

Cabozantinib-S-Malate in Treating Patients With Hormone-Resistant Metastatic Prostate Cancer

A study testing cabozantinib-s-malate, fluorine F 18 d-FMAU and positron emission tomography in people with Adenocarcinoma of the Prostate and Hormone-resistant Prostate Cancer, run by Barbara Ann Karmanos Cancer Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This pilot clinical trial studies cabozantinib-s-malate in treating patients with hormone-resistant metastatic prostate cancer. Cabozantinib-s-malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
cabozantinib-s-malate, fluorine F 18 d-FMAU and positron emission tomography
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
Mar 2013to 18 Jun 2019
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The subject has histologically confirmed prostate adenocarcinoma with radiologic evidence of metastases
  • If patient are on anti-androgens, these should be discontinued, at least 4 weeks prior for flutamide and at least 6 weeks for bicalutamide or nilutamide
  • At least 14 days should have elapsed from prior radiation therapy to bone metastases from prostate cancer
  • The patient has received a maximum of one prior chemotherapy regimen for metastatic prostate cancer
  • Patients must demonstrate disease progression on or after most recent systemic therapy, either by prostate-specific antigen (PSA), new bone metastases or by measurable disease criteria per Response Evaluation Criteria in Solid Tumors (RECIST) guidelines
  • Patients should have received either luteinizing hormone-releasing hormone (LHRH) analogue, or LHRH analogue and anti- androgen for metastatic prostate cancer
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  • The patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Bisphosphonate therapy can be continued if started prior to protocol enrollment
  • Patients must have blood pressure (BP) readings < 150/90 prior to enrollment
  • Absolute neutrophil count (ANC) >= 1500/mm^3 without colony stimulating factor support
  • Platelets >= 100,000/mm^3
  • Hemoglobin >= 9 g/dL
  • Bilirubin =< 1.5 x the upper limit of normal (ULN); for subjects with known Gilbert's disease, bilirubin =< 3.0 mg/dL
  • Serum albumin >= 2.8 g/dl
  • Serum creatinine =< 1.5 x ULN or creatinine clearance (CrCl) >= 50 mL/min; for creatinine clearance estimation, the Cockcroft and Gault equation should be used
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2.5 x ULN if no liver involvement, or =< 5 x ULN with liver involvement
  • Lipase < 1.5 x the upper limit of normal (except for subjects with adenocarcinoma of the pancreas)
  • Urine protein/creatinine ratio (UPCR) =< 1
  • Serum phosphorus >= lower limit of normal (LLN)
  • The subject is capable of understanding and complying with the protocol requirements and has signed the informed consent document
  • Patients participating in this trial must also be eligible and willing to sign consent for participation in [2'-18F]-1-(2'-deoxy-2'-fluoro-beta-D-arabinofuranosyl)thymine (FMAU) and 18F-flouride positron emission tomography (PET) scans done under separate protocols
  • Sexually active subjects (men) must agree to use medically accepted barrier methods of contraception (eg, male condom, or diaphragm with spermicidal gel) 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 by the female partner; all subjects of reproductive potential must agree to use both a barrier method and a second method of birth control
  • Projected life expectancy of at least 6 months
  • No prior history of other malignancies in the last 3 years, except for squamous and basal cell skin cancer

Who cannot join

  • The subject has received cytotoxic chemotherapy (including investigational cytotoxic chemotherapy) or biologic agents (eg, cytokines or antibodies) within 3 weeks, or nitrosoureas/mitomycin C within 6 weeks before the first dose of study treatment
  • Prior treatment with cabozantinib
  • The subject has received radiation therapy:
  • To the thoracic cavity or gastrointestinal tract within 3 months of the first dose of study treatment
  • To bone or brain metastasis within 14 days of the first dose of study treatment
  • To any other site(s) within 28 days of the first dose of study treatment
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  • The subject has received radionuclide treatment within 6 weeks of the first dose of study treatment
  • The subject has received prior treatment with a small molecule kinase inhibitor or a hormonal therapy (including investigational kinase inhibitors or hormones) within 14 days or five half-lives of the compound or active metabolites, whichever is longer, before the first dose of study treatment; patients receiving LHRH or gonadotropin-releasing hormone (GnRH) agonists to maintain castrate levels of testosterone or patients on bisphosphonate/denosumab, may be maintained on these agents
  • The subject has received any other type of investigational agent within 28 days before the first dose of study treatment
  • The subject has not recovered to baseline or Common Terminology Criteria for Adverse Events (CTCAE) =< grade 1 from toxicity due to all prior therapies except alopecia and other non-clinically significant adverse events (AEs)
  • The subject has a primary brain tumor
  • The subject has active brain metastases or epidural disease (Note: Subjects with brain metastases previously treated with whole brain radiation or radiosurgery or subjects with epidural disease previously treated with radiation or surgery who are asymptomatic and do not require steroid treatment for at least 2 weeks before starting study treatment are eligible; neurosurgical resection of brain metastases or brain biopsy is permitted if completed at least 3 months before starting study treatment; baseline brain scans are not required to confirm eligibility)
  • The subject has prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) test results at screening >= 1.3 x the laboratory ULN
  • The subject requires concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin or warfarin-related agents, heparin, thrombin or Factor xabans (Xa) inhibitors, or antiplatelet agents (eg, clopidogrel); low dose aspirin (=< 81 mg/day), low-dose warfarin (=< 1 mg/day), and prophylactic low molecular weight heparin (LMWH) are permitted
  • The subject has experienced any of the following within 3 months before the first dose of study treatment:
  • Clinically-significant hematemesis or gastrointestinal bleeding
  • Hemoptysis of >= 0.5 teaspoon (2.5 ml) of red blood
  • Any other signs indicative of pulmonary hemorrhage
  • The subject has radiographic evidence of cavitating pulmonary lesion(s)
  • The subject has tumor in contact with, invading or encasing major blood vessels
  • The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:
  • Cardiovascular disorders including
  • Congestive heart failure (CHF): New York Heart Association (NYHA) class III (moderate) or class IV (severe) at the time of screening
  • Concurrent uncontrolled hypertension defined as sustained BP > 140 mmHg systolic, or > 90 mmHg diastolic despite optimal antihypertensive treatment (BP must be controlled at screening)
  • Any of the following within 6 months before the first dose of study treatment:
  • Unstable angina pectoris
  • Clinically-significant cardiac arrhythmias
  • Stroke (including transient ischemic attack [TIA], or other ischemic event)
  • Myocardial infarction
  • Thromboembolic event requiring therapeutic anticoagulation (Note: subjects with a venous filter (e.g. vena cava filter) are not eligible for this study)
  • Gastrointestinal disorders particularly those associated with a high risk of perforation or fistula formation including:
  • Any of the following at the time of screening
  • Intra-abdominal tumor/metastases invading gastrointestinal (GI) mucosa
  • Active peptic ulcer disease
  • Inflammatory bowel disease (including ulcerative colitis and Crohn's disease), diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis
  • Any of the following within 6 months before the first dose of study treatment:
  • History of abdominal fistula
  • Gastrointestinal perforation
  • Bowel obstruction or gastric outlet obstruction
  • Intra-abdominal abscess. Note: Complete resolution of an intraabdominal abscess must be confirmed prior to initiating treatment with cabozantinib even if the abscess occurred more that 6 months ago
  • GI surgery (particularly when associated with delayed or incomplete healing) within 28 days; Note: Complete healing following abdominal surgery must be confirmed prior to initiating treatment with cabozantinib even if surgery occurred more that 28 days ago
  • Other disorders associated with a high risk of fistula formation including percutaneous endoscopic gastrostomy (PEG) tube placement within 3 months before the first dose of study therapy or concurrent evidence of intraluminal tumor involving the trachea and esophagus
  • Other clinically significant disorders such as:
  • Active infection requiring systemic treatment
  • Serious non-healing wound/ulcer/bone fracture
  • History of organ transplant
  • Concurrent uncompensated hypothyroidism or thyroid dysfunction
  • History of major surgery within 4 weeks or minor surgical procedures within 1 week before randomization
  • The subject is unable to swallow tablets
  • The subject has a corrected QT interval calculated by the Fridericia formula (QTcF) > 470 ms within 28 days before randomization
  • The subject has a previously identified allergy or hypersensitivity to components of the study treatment formulation
  • The subject is unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee
  • The subject has had evidence within 2 years of the start of study treatment of another malignancy, which required systemic treatment

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201

Other trials in United States

About this study

Official title: Pilot Trial of Oral Cabozantinib/XL184 in Metastatic Castrate Resistant Prostate Cancer to Explore the Changes in Bone and Tumor Imaging Related Pathways

This pilot clinical trial studies cabozantinib-s-malate in treating patients with hormone-resistant metastatic prostate cancer. Cabozantinib-s-malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth

Read the detailed description

PRIMARY OBJECTIVES:

  1. To evaluate the timing, pathophysiology, and magnitude of changes in tumor imaging and pharmacodynamic markers with XL184 (cabozantinib-s-malate) treatment in metastatic castrate resistant prostate cancer.

SECONDARY OBJECTIVES:

  1. To estimate the progression-free survival (PFS) achieved with XL184 in metastatic castrate resistant prostate cancer (CRPC) patients.

II. To evaluate the feasibility of the therapy, and the toxicities associated. III. To evaluate overall survival (OS) in metastatic CRPC patients post androgen deprivation therapy (ADT) treated with XL-184.

OUTLINE:

Patients receive cabozantinib-s-malate orally (PO) daily in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 4 weeks and then periodically thereafter.

Being tested
cabozantinib-s-malate, fluorine F 18 d-FMAU, positron emission tomography, pharmacological study, laboratory biomarker analysis
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cabozantinib-s-malateDrug

    Also called BMS-907351, Cometriq, XL184

    Given PO

  • fluorine F 18 d-FMAURadiation

    Undergo 18F PET/FMAU PET scan

  • positron emission tomographyProcedure or surgery

    Also called FDG-PET, PET, PET scan, tomography, emission computed

    Undergo 18F PET/FMAU PET scan

  • pharmacological studyOther

    Also called pharmacological studies

    Correlative studies

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT01812668
Study groupRoleWhat they receive
Treatment (cabozantinib-s-malate)ExperimentalPatients receive cabozantinib-s-malate PO daily in the absence of disease progression or unacceptable toxicity.
Receives: Drug: cabozantinib-s-malate; Radiation: fluorine F 18 d-FMAU; Procedure: positron emission tomography; Other: pharmacological study; Other: laboratory biomarker analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in PET Standard Uptake Value SUV Levels Pre-treatment to Post-treatment.

    Change in PET standard uptake value SUV levels (each value measured in g/ml). (post-treatment - pre-treatment)/pre-treatment x 100 , therefore, measured in percentage change from baseline.

    Measured: Baseline to 4 weeks

Secondary outcomes (5)

  1. Time to Progression

    Summarized via the Kaplan-Meier (K-M) survivorship estimate.

    Measured: From date of registration to date of first documented disease progression, or death from any cause, assessed up to 1 year

  2. Number of Participants With Indicated Toxicities Grade 3 or Higher

    Type of toxicities graded per National Cancer Institute (NCI) CTCAE version 4.0 Summarized via their frequency distribution and point estimate of the proportion.

    Measured: Up to 4 weeks post-treatment, about 2 years on average.

  3. Number of Participants With Indicated Clinical Response Based on the RECIST Criteria 1.1

    Number of Participants with Indicated Clinical response based on the RECIST criteria 1.1 summarized via their frequency distribution.

    Measured: Up to 1 year

  4. PSA Response Based on the RECIST Criteria 1.1

    Summarized via their frequency distribution, point estimate of the proportion, and the Wilson type 80% CI.

    Measured: Up to 1 year

  5. PET Response Based on the RECIST Criteria 1.1

    Summarized via their frequency distribution, point estimate of the proportion, and the Wilson type 80% CI.

    Measured: Up to 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2013 (estimated)
  2. Study startMar 2013
  3. Primary completion18 Jan 2019
  4. Study completion18 Jun 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01812668
Sponsor's protocol ID
2011-185
Other IDs
NCI-2013-00399
Status last verified
Aug 2021
First submitted
14 Mar 2013
Last updated
5 Aug 2021
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing cabozantinib-s-malate, fluorine F 18 d-FMAU and positron emission tomography in people with Adenocarcinoma of the Prostate and Hormone-resistant Prostate Cancer, run by Barbara Ann Karmanos Cancer Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 24 inclusion and 53 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in PET Standard Uptake Value SUV Levels Pre-treatment to Post-treatment. (time frame: Baseline to 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01812668.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2021.

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