Prostate CancerPhase 1/2NCT01335204
Ph Ib/IIa Study of Cabazitaxel Plus Bavituximab in Castration-resistant Prostate Cancer
A Phase 1/2 study testing Cabazitaxel plus bavituximab in people with Prostate Cancer and Prostatic Neoplasms, run by Medical University of South Carolina at 1 site in United States.
Trial summary
This is a Phase Ib/IIa Study of Cabazitaxel plus Bavituximab in patients with castration-resistant prostate cancer (CRPC). The current study is designed to determine if the addition of bavituximab to cabazitaxel will improve progression free survival (PFS) or overall survival (OS). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Prostatic Neoplasms
- What is being tested?
- Cabazitaxel plus bavituximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Mar 2013
- Phase
- Phase 1/2
- 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
- Written informed consent has been obtained.
- Adults 18 years of age or older with a life expectancy of at least 3 months.
- Histologically confirmed castration-resistant prostate cancer (CRPC). Patient must have demonstrated a rising PSA level above the androgen-deprivation therapy (ADT) nadir, on at least two determinations four weeks or more apart. ADT is defined as treatment with a Luteinizing-hormone-releasing hormone (LHRH) agonist or orchiectomy.
- Treatment with only one prior chemotherapy regimen, which must contain docetaxel as a single agent or in combination with other agents. Patients may be intolerant of, or resistant to, the cytotoxic drug combination.
- Patients on ADT must be willing to continue ADT for the duration of their participation in this protocol. ADT cannot be initiated, and ADT dose/agents may not be changed during the study.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
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- Adequate hematologic function (absolute neutrophil count [ANC] ≥ 1,500 cells/μL; hemoglobin ≥ 8 g/dL, platelets ≥ 100,000/μL).
- Adequate renal function (serum creatinine ≤ 1.5 mg/dL or calculated creatinine clearance ≥ 60 mL/min).
- Adequate hepatic function (bilirubin ≤ 1.0 x upper limit of normal [ULN], alanine aminotransferase [ALT] ≤ 1.5 x ULN, aspartate aminotransferase [AST] ≤ 1.5 x ULN).
- Prothrombin time (PT) / international normalized ratio (INR) ≤ 1.5 × ULN.
- Activated partial thromboplastin (aPTT) time ≤ 1.5 × ULN.
- Prostate-specific antigen (PSA) level of at least 2 ng/mL.
- New York Heart Association classification I or II.
- All patients of reproductive potential must agree to use an approved form of contraception (as determined by the investigator).
Who cannot join
- Known history of bleeding diathesis or coagulopathy (e.g., von Willebrand disease or hemophilia).
- Any history of thromboembolic events (e.g., deep vein thrombosis or pulmonary thromboembolism); central venous catheter-related thrombosis > 6 months before Screening is allowed.
- Ongoing therapy with oral or parenteral anticoagulants; patients on low-dose anticoagulants to maintain patency of central venous catheters are eligible.
- Grade 2 or higher peripheral neuropathy (e.g., numbness, tingling, and/or pain in distal extremities).
- Radiotherapy (teletherapy or brachytherapy) , chemotherapy or estrogen agonist within 28 days before Study Day 1.
- Systemic radiotherapy (Sm-153, Sr-89) within 56 days before study day 1.
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- Symptomatic or clinically active brain metastases.
- Major surgery within 28 days of Study Day 1.
- Uncontrolled intercurrent disease (eg, diabetes, hypertension, thyroid disease).
- Any history of cerebrovascular accident, or transient ischemic attack at any time, or history of symptomatic coronary artery disease < 6 months before screening.
- A history of any condition requiring anti-platelet therapy (eg, phosphodiesterase inhibitors, adenosine diphosphate receptor antagonists), with the exception of general cardiovascular prophylaxis with aspirin (≤ 325 mg/day).
- Serious non-healing wound (including wound healing by secondary intention, ulcer, or bone fracture).
- Known chronic infection with human immunodeficiency virus (HIV) or viral hepatitis.
- Contraindication to intravenous (IV) contrast media.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Phase Ib/IIa Study of Cabazitaxel Plus Bavituximab for Patients With Castration-resistant Prostate Cancer Previously Treated With Chemotherapy
This is a Phase Ib/IIa Study of Cabazitaxel plus Bavituximab in patients with castration-resistant prostate cancer (CRPC). The current study is designed to determine if the addition of bavituximab to cabazitaxel will improve progression free survival (PFS) or overall survival (OS). In addition, the Lead Researcher is requiring the collection of urine, and blood specimens for future research.
This study will enroll patients with CRPC, who have been previously treated with docetaxel or a docetaxel-containing regimen. Patients may be intolerant of, or resistant to, docetaxel, or may have been previously treated with the agent without definite disease progression during therapy.
Patients must meet the study eligibility criteria and must be competent to give informed consent.
Read the detailed description
Cabazitaxel will be administered IV on day 1 of each 21-day treatment cycle. Bavituximab (3 mg/kg) will be administered as an intravenous (IV) infusion on a weekly basis (Cycle 1 Day 2, all other cycles Day 1; day 8, day 15). Patients will receive cabazitaxel (day 1) plus bavituximab weekly of each 21-day cycle for up to 8 cycles.
Up to 31 patients will be enrolled to ensure 28 evaluable subjects. The accrual period is expected to be between 12 to 18 months (1-1.5 years).
Subjects will remain on the treatment phase of the study until any of the following events occur:
- Disease progression as evidenced by an increase in the prostate-specific antigen (PSA) level, worsening of pain, or disease progression by Response Evaluation Criteria in Solid Tumors (RECIST)
- Completion of 8 cycles of cabazitaxel-bavituximab therapy (day 169)
- Development of toxicity that, in the investigator's judgment, precludes further study participation
- Significant protocol violations or noncompliance on the part of the patient or investigator
- The investigator's judgment that discontinuation is in the patient's best interest
- Initiation of alternative antineoplastic treatments.
- Refusal of the patient to continue treatment or follow-up
- Loss to follow-up
After completion of the treatment phase, subjects will remain on the followup phase of the study until any of the following events occur:
- Refusal of the patient to continue treatment or follow-up
- Loss to follow-up
- Death
- The investigator's judgment that discontinuation is in the patient's best interest
- Conditions
- Prostate Cancer, Prostatic Neoplasms
- Being tested
- Cabazitaxel plus bavituximab
- Keywords
- Castration-resistant prostate cancer, Prostate Cancer, JEVTANA, Cabazitaxel, Bavituximab
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cabazitaxel plus bavituximabDrug
Also called JEVTANA® (cabazitaxel)
Cabazitaxel (25 mg/m2) will be administered IV on Day 1 of each 21-day treatment cycle, and bavituximab (3 mg/kg) will be administered as an IV infusion on a weekly basis (Cycle 1 Day 2, all other cycles Day 1; day 8; day 15) for 8 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Cabazitaxel plus bavituximab | Experimental | Cabazitaxel (25 mg/m2) will be administered IV on Day 1 of each 21-day treatment cycle. Bavituximab (3 mg/kg) will be administered as an IV infusion on a weekly basis (Cycle 1 Day 2, all other cycles Day 1; day 8; day 15) for 8 cycles. Receives: Drug: Cabazitaxel plus bavituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probability of Progression-free Survival at Day 85
The primary objective of this study is to determine the probability of progression-free survival (PFS) after 12 weeks of therapy in subjects with CRPC treated with cabazitaxel + bavituximab.
Measured: 12 weeks
Secondary outcomes (5)
Measurement of PSA Response Rate
To estimate the PSA response rate from cabazitaxel + bavituximab therapy in CRPC patients previously treated with docetaxel. PSA response rate will be assessed at multiple time points during the 24 wks of study treatment.
Measured: 24 weeks
Objective Response Rate by RECIST for Patients With Measurable Disease
To estimate the objective response rate from cabazitaxel + bavituximab therapy in CRPC patients previously treated with docetaxel. Objective response rate will be assessed at day 85, 169
Measured: 24 weeks
Overall Survival
To estimate the overall survival in subjects with CRPC (previously treated with docetaxel) following cabazitaxel + bavituximab therapy. Overall survival will be assessed continually during the duration of the study.
Measured: 24+ weeks
Number of With Grade 3 or 4 Toxicities
To document the toxicity of cabazitaxel + bavituximab therapy in CRPC patients previously treated with docetaxel. Toxicity will be assessed continually during the 24 wks of study therapy.
Measured: 24 weeks
Progression-free Survival (PFS)
Determination of progression-free survival in subjects treated with cabazitaxel + bavituximab for CRPC previously treated with docetaxel. PFS will be assessed continually during the entire study.
Measured: 24+ weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2011 (estimated)
- Study startJun 2011
- Primary completionMar 2013
- Study completionMar 2013
Why it stopped: lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Peregrine Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Michael Lilly, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01335204
- Sponsor's protocol ID
- MUSC 101637
- Other IDs
- HS#2011-8083, NCI-2011-01248
- Status last verified
- Jun 2018
- First submitted
- 11 Apr 2011
- Last updated
- 13 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ib/IIa Study of Cabazitaxel Plus Bavituximab for Patients With Castration-resistant Prostate Cancer Previously Treated With Chemotherapy
- ClinicalTrials.gov ID
- NCT01335204
- Acronym / sponsor ID
- MUSC 101637
- Conditions
- Prostate Cancer, Prostatic Neoplasms
- Keywords
- Castration-resistant prostate cancer, Prostate Cancer, JEVTANA, Cabazitaxel, Bavituximab
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of funding
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- Peregrine Pharmaceuticals
- Study start
- Jun 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 14 Apr 2011 (estimated)
- Results
- Posted 13 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase Ib/IIa Study of Cabazitaxel plus Bavituximab in patients with castration-resistant prostate cancer (CRPC). The current study is designed to determine if the addition of bavituximab to cabazitaxel will improve progression free survival (PFS) or overall survival (OS). In addition, the Lead Researcher is requiring the collection of urine, and blood specimens for future research.
This study will enroll patients with CRPC, who have been previously treated with docetaxel or a docetaxel-containing regimen. Patients may be intolerant of, or resistant to, docetaxel, or may have been previously treated with the agent without definite disease progression during therapy.
Patients must meet the study eligibility criteria and must be competent to give informed consent.
Detailed description
Cabazitaxel will be administered IV on day 1 of each 21-day treatment cycle. Bavituximab (3 mg/kg) will be administered as an intravenous (IV) infusion on a weekly basis (Cycle 1 Day 2, all other cycles Day 1; day 8, day 15). Patients will receive cabazitaxel (day 1) plus bavituximab weekly of each 21-day cycle for up to 8 cycles.
Up to 31 patients will be enrolled to ensure 28 evaluable subjects. The accrual period is expected to be between 12 to 18 months (1-1.5 years).
Subjects will remain on the treatment phase of the study until any of the following events occur:
- Disease progression as evidenced by an increase in the prostate-specific antigen (PSA) level, worsening of pain, or disease progression by Response Evaluation Criteria in Solid Tumors (RECIST)
- Completion of 8 cycles of cabazitaxel-bavituximab therapy (day 169)
- Development of toxicity that, in the investigator's judgment, precludes further study participation
- Significant protocol violations or noncompliance on the part of the patient or investigator
- The investigator's judgment that discontinuation is in the patient's best interest
- Initiation of alternative antineoplastic treatments.
- Refusal of the patient to continue treatment or follow-up
- Loss to follow-up
After completion of the treatment phase, subjects will remain on the followup phase of the study until any of the following events occur:
- Refusal of the patient to continue treatment or follow-up
- Loss to follow-up
- Death
- The investigator's judgment that discontinuation is in the patient's best interest
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cabazitaxel plus bavituximab | Experimental | Drug: Cabazitaxel plus bavituximabCabazitaxel (25 mg/m2) will be administered IV on Day 1 of each 21-day treatment cycle. Bavituximab (3 mg/kg) will be administered as an IV infusion on a weekly basis (Cycle 1 Day 2, all other cycles Day 1; day 8; day 15) for 8 cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Written informed consent has been obtained.
- Adults 18 years of age or older with a life expectancy of at least 3 months.
- Histologically confirmed castration-resistant prostate cancer (CRPC). Patient must have demonstrated a rising PSA level above the androgen-deprivation therapy (ADT) nadir, on at least two determinations four weeks or more apart. ADT is defined as treatment with a Luteinizing-hormone-releasing hormone (LHRH) agonist or orchiectomy.
- Treatment with only one prior chemotherapy regimen, which must contain docetaxel as a single agent or in combination with other agents. Patients may be intolerant of, or resistant to, the cytotoxic drug combination.
- Patients on ADT must be willing to continue ADT for the duration of their participation in this protocol. ADT cannot be initiated, and ADT dose/agents may not be changed during the study.
Key exclusion criteria (14 listed)
- Known history of bleeding diathesis or coagulopathy (e.g., von Willebrand disease or hemophilia).
- Any history of thromboembolic events (e.g., deep vein thrombosis or pulmonary thromboembolism); central venous catheter-related thrombosis > 6 months before Screening is allowed.
- Ongoing therapy with oral or parenteral anticoagulants; patients on low-dose anticoagulants to maintain patency of central venous catheters are eligible.
- Grade 2 or higher peripheral neuropathy (e.g., numbness, tingling, and/or pain in distal extremities).
- Radiotherapy (teletherapy or brachytherapy) , chemotherapy or estrogen agonist within 28 days before Study Day 1.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cabazitaxel plus bavituximabAlso: JEVTANA® (cabazitaxel)Cabazitaxel (25 mg/m2) will be administered IV on Day 1 of each 21-day treatment cycle, and bavituximab (3 mg/kg) will be administered as an IV infusion on a weekly basis (Cycle 1 Day 2, all other cycles Day 1; day 8; day 15) for 8 cycles. | Drug | Cabazitaxel plus bavituximab |
Primary outcome
Probability of Progression-free Survival at Day 85
Time frame: 12 weeks
The primary objective of this study is to determine the probability of progression-free survival (PFS) after 12 weeks of therapy in subjects with CRPC treated with cabazitaxel + bavituximab.
5 secondary outcomes
Measurement of PSA Response Rate
Time frame: 24 weeks
Objective Response Rate by RECIST for Patients With Measurable Disease
Time frame: 24 weeks
Overall Survival
Time frame: 24+ weeks
Number of With Grade 3 or 4 Toxicities
Time frame: 24 weeks
Progression-free Survival (PFS)
Time frame: 24+ weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Lilly, MD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Cabazitaxel plus bavituximab in people with Prostate Cancer and Prostatic Neoplasms, run by Medical University of South Carolina 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 14 inclusion and 14 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: stopped early, as of the sponsor's last update on 13 Jul 2018. 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.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jul 2018). 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?
Probability of Progression-free Survival at Day 85 (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jul 2018.