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Prostate CancerPhase 1NCT01385228

Pazopanib, Docetaxel, Prednisone Prostate

A Phase 1 study testing Pazopanib, Docetaxel and Prednisone in people with Prostate Cancer, run by Daniel George, MD at 2 sites 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

The primary purpose is to define the safety and tolerability of docetaxel/prednisone in combination with pazopanib (DPP) in men with metastatic Castration Resistant Prostate Cancer (mCRPC). Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Pazopanib, Docetaxel and Prednisone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
2 sitesUnited States
Study dates
Jun 2011to Feb 2016
Phase
Phase 1
Are there results?
None posted in the registry

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

  • Histologically confirmed carcinoma of the prostate. Histologic evidence may be confirmed through local or metastatic biopsy review. Non-adenocarcinomas are permitted.
  • Radiographic evidence of metastatic disease; non-evaluable, bone only metastasis is permitted.
  • Evidence of disease progression despite castrate levels of testosterone (<50 ng/dl).
  • At the time of screening, at least 2 weeks since prior palliative radiation therapy and 4 weeks from major surgery, and resolution of all toxic effects of prior therapy to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE); version 4.0 Grade < 1.
  • Age >18 years
  • Adequate laboratory parameters
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  • Eastern Cooperative Oncology Group (ECOG) performance status between 0 and 2
  • Life expectancy greater than 3 months
  • Written, signed and dated Institutional Review Board (IRB) approved informed consent form.

Who cannot join

  • History of or active central nervous system metastases
  • The use of immunologic, biologic, or hormonal therapies within 2 weeks of study entry.
  • Major surgery, open biopsy, traumatic injury within 4 weeks of the screening visit
  • Subjects who have not recovered from prior biopsy, surgery, traumatic injury, and/or radiation therapy.
  • Previous treatment with docetaxel, including in the neo-adjuvant or adjuvant setting
  • Presence of non-healing wound or ulcer
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  • Grade 3 or greater hemorrhage within the past month.
  • Uncontrolled hypertension
  • American Heart Association Class 2-4 heart disease or any history of congestive heart failure with an ejection fraction <40%, recent cardiovascular event (within 12 months) including unstable angina, any exertional angina, myocardial infarction, exertional or rest claudication, or stroke/Cerebral Vascular Event/Transient Ischemic Attack. Patients with known moderate to severe documented carotid or peripheral vascular disease are excluded. Angioplasty or stenting of coronary or peripheral arteries are exclusionary if within the past 12 months.
  • Anticoagulation with warfarin (therapeutic doses of warfarin for catheter patency are permitted up to 2 mg/day). Low molecular weight heparin is permitted.
  • Diabetes mellitus with glycosylated hemoglobin A1c (HbgA1c) > 8% despite therapy
  • Subjects with active autoimmune disorder(s) being treated with systemic immunosuppressive agents within 4 weeks prior to the screening visit.
  • Active infection(s), active antimicrobial therapy or serious intercurrent illness.
  • Does not agree to use medically acceptable contraceptive methods while on study and for 3 months after the last dose of pazopanib.
  • Any other major medical or psychiatric illness that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in this study, including inability to absorb oral medications.
  • Known hypersensitivity to any of the components in the docetaxel infusion or other medical reasons for not being able to receive adequate premedication (for example, antihistamine or anti-inflammatory agents).
  • CalculatedQT (QTc) interval on baseline EKG > 500milliseconds
  • History or presence of nephrotic syndrome

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • The University of Chicago

    Chicago, Illinois, 60637

  • Duke Cancer Institute

    Durham, North Carolina, 27710

Other trials in United States

About this study

Official title: Phase I Study of Docetaxel, Prednisone and Pazopanib in Men With Metastatic Castrate-Resistant Prostate Cancer (mCRPC) and Poor-Risk Factors

The primary purpose is to define the safety and tolerability of docetaxel/prednisone in combination with pazopanib (DPP) in men with metastatic Castration Resistant Prostate Cancer (mCRPC).

Read the detailed description

This Phase I study will consist of a dose escalation portion which includes a dose escalation phase of 10 dose levels: (1a) docetaxel 60 mg/m2, pazopanib 400 mg daily, prednisone 5 mg BID; (2a) docetaxel 75 mg/m2, pazopanib 400 mg daily, prednisone 5 mg BID; and (3a) docetaxel 75 mg/m2, pazopanib 600 mg daily, prednisone 5 mg BID; (4a) docetaxel 75mg/m2, pazopanib 800 mg daily, (5a) docetaxel 75mg/m2, pazopanib 1000mg daily, prednisone 5 mg; (1b) docetaxel 60 mg/m2, pazopanib 400 mg daily x 17 days, prednisone 5 mg BID; (2b) docetaxel 75 mg/m2, pazopanib 400 mg daily x 17 days, prednisone 5 mg BID; and (3b) docetaxel 75 mg/m2, pazopanib 600 mg daily x 17 days, prednisone 5 mg BID; (4b) docetaxel 75mg/m2, pazopanib 800 mg daily x 17 days, (5b) docetaxel 75mg/m2, pazopanib 1000mg daily x 17 days, prednisone 5 mg. If the investigators see > 1 dose limiting toxicity (DLT) at Dose level 3 then the investigators would investigate docetaxel 75 mg/m2, pazopanib 600 mg daily, prednisone 5 mg BID (Dose level 3a). If < 1 DLT are seen at Dose level 3 and Pharmacokinetic (PK) analysis is complete and acceptable, then the investigators will proceed to dose level 4) docetaxel 75 mg/m2, pazopanib 1000 mg daily, prednisone 5 mg BID.

The investigators will dose escalate in a classic 3+3 design. The maximum tolerated dose (MTD) will be defined as the highest dose level that does not result in 2 or more dose limiting toxicities (DLTs). A dose expansion at the MTD of 10-15 patients (up to a total of 36 patients) will be accrued in order to further describe the safety profile.

Conditions
Prostate Cancer
Being tested
Pazopanib, Docetaxel, Prednisone, Pegfilgrastim
Keywords
prostate cancer, metastatic, pazopanib, docetaxel, metastatic prostate cancer
Medical subject headings
Prostatic Neoplasms, Neoplasm Metastasis

What participants receive

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

  • PazopanibDrug

    Also called Pazopanib (GW786034)

    Dose Level "Xa" - daily administration of pazopanib on days 1 through 21 starting at 400mg with a maximum dose of 1000mg.

  • DocetaxelDrug

    Also called Taxotere

    Docetaxel given IV on Day 1 starting dose 60mg/m2 increase to 75mg/m2

  • PazopanibDrug

    Also called Pazopanib (GW786034)

    Dose Level "Xb" - daily administration of pazopanib on days 3 through 19 starting at 400mg with a maximum dose of 1000mg.

  • PrednisoneDrug

    5mg Prednisone given twice daily days 1-21.

  • PegfilgrastimDrug

    Also called Neulasta

Study groups in NCT01385228
Study groupRoleWhat they receive
Dose Level "Xa"Experimentalonce daily pazopanib for Days 1-21 in combination with docetaxel given IV on Day 1 and prednisone daily. Pegfilgrastim (Neulasta) every 21 days on Day 2, 3 or 4 of each cycle.
Receives: Drug: Pazopanib; Drug: Docetaxel; Drug: Prednisone; Drug: Pegfilgrastim
Dose Level "Xb"Experimentalonce daily oral administration of pazopanib for Days 3-19 in combination with docetaxel given intravenous administration on Day 1 and prednisone daily. Pegfilgrastim (Neulasta) every 21 days on Day 2, 3 or 4 of each cycle.
Receives: Drug: Docetaxel; Drug: Pazopanib; Drug: Prednisone; Drug: Pegfilgrastim

What is being measured

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

  1. Number and Percent of Participants with Adverse Events as a Measure of Safety and Tolerability

    The primary objective for the phase I study is to assess the safety and tolerability of pazopanib, docetaxel, and prednisone given in combination in patients with metastatic castration resistant prostate cancer.

    Measured: 15 months

Secondary outcomes (2)

  1. Establish the maximum tolerated dose

    Determine the dose levels of pazopanib and docetaxel that are the most tolerated.

    Measured: 15 months

  2. Establish the optimal dosing schedule

    Establish the optimal dosing schedule for the combination of docetaxel, prednisone and pazopanib

    Measured: 15 months

Timeline

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

  1. First posted30 Jun 2011 (estimated)
  2. Study startJun 2011
  3. Primary completionJul 2015
  4. Study completionFeb 2016

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 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01385228
Sponsor's protocol ID
Pro00026577
Other IDs
PZP113296, c09-039
Status last verified
Jun 2018
First submitted
12 Jun 2011
Last updated
6 Jun 2018
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Pazopanib, Docetaxel and Prednisone in people with Prostate Cancer, run by Daniel George, MD at 2 sites 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 9 inclusion and 18 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 6 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Number and Percent of Participants with Adverse Events as a Measure of Safety and Tolerability (time frame: 15 months). 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 NCT01385228.

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 6 Jun 2018.

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Pazopanib, Docetaxel, Prednisone Prostate | AzTrials