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Onvansertib in Combination With Abiraterone and Prednisone in Adult Patients With Metastatic Castration-Resistant Prostate Cancer

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ClinicalTrials.gov Identifier: NCT03414034
Recruitment Status : Recruiting
First Posted : January 29, 2018
Last Update Posted : June 24, 2019
Sponsor:
Information provided by (Responsible Party):
Trovagene, Inc.

Tracking Information
First Submitted Date  ICMJE January 22, 2018
First Posted Date  ICMJE January 29, 2018
Last Update Posted Date June 24, 2019
Actual Study Start Date  ICMJE June 18, 2018
Estimated Primary Completion Date October 16, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 26, 2018)
Percentage of Participants With Lack of Prostate-specific Antigen (PSA) Progression per Prostate Cancer Working Group 3 (PCWG3) criteria After 12 Weeks [ Time Frame: Week 12 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03414034 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 26, 2018)
  • Percentage Change from Baseline in PSA at 12 Weeks [ Time Frame: Baseline and Week 12 ]
  • Maximal Percentage Change from Baseline in PSA [ Time Frame: Baseline up to 20 months ]
  • Absolute Change from Baseline in PSA Response [ Time Frame: Baseline up to 20 months ]
  • Time to PSA Progression per PCWG3 criteria [ Time Frame: Baseline up to 20 months ]
  • Time to Radiographic Progression per PCWG3 criteria [ Time Frame: Baseline up to 20 months ]
  • Radiographic Response per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) [ Time Frame: Baseline up to 20 months ]
  • Number of Participants With Dose Limiting Toxicity (DLT) [ Time Frame: Up to 20 months ]
    DLT is defined as a grade 4 hematologic adverse event (AE) or nonhematologic AE of Grade ≥3 considered related to the study drug(s).
  • Number of Participants With Adverse Events per Common Terminology Criteria for Adverse Events (CTCAE) [ Time Frame: Baseline up to 30 days after last dose of study drug (Up to 20 months) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Onvansertib in Combination With Abiraterone and Prednisone in Adult Patients With Metastatic Castration-Resistant Prostate Cancer
Official Title  ICMJE A Phase 2 Study of PCM-075 (Onvansertib) in Combination With Abiraterone and Prednisone in Adult Patients With Metastatic Castration-Resistant Prostate Cancer
Brief Summary The purpose of the phase 2 study is to determine whether Onvansertib given orally once daily for 5 consecutive days every 14 or 21 days is safe and tolerable in adult patients with Metastatic Castration-Resistant Prostate Cancer who have disease progression while receiving abiraterone acetate (abiraterone) and prednisone therapy, and to observe the effects of Onvansertib in combination with abiraterone and prednisone on disease control.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Castration-Resistant Prostate Cancer
Intervention  ICMJE
  • Drug: Onvansertib
    Onvansertib orally
    Other Name: PCM-075
  • Drug: Abiraterone
    Abiraterone orally
  • Drug: Prednisone
    Prednisone orally
Study Arms  ICMJE
  • Experimental: Onvansertib + abiraterone and prednisone
    Onvansertib, 24 mg/m^2, administered orally Day 1 through Day 5 every 21 days (1 cycle) in combination with the standard dose of abiraterone (1000 mg orally once daily; four 250 mg tablets or two 500 mg film-coated tablets) and prednisone (5 mg orally once daily).
    Interventions:
    • Drug: Onvansertib
    • Drug: Abiraterone
    • Drug: Prednisone
  • Experimental: Onvansertib, abiraterone and prednisone
    PCM-075 administered orally once daily at a dose of 24 mg/m^2 for five days (Day 1 through Day 5) out of a 14-day cycle. Beginning on Day 1 and continuing uninteruupted throughout each cycle, patients will also receive abiraterone and prednisone. Dosing of PCM-075 can be administered at the same time the patient is administered their dose of abiraterone.
    Interventions:
    • Drug: Onvansertib
    • Drug: Abiraterone
    • Drug: Prednisone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 10, 2019)
64
Original Estimated Enrollment  ICMJE
 (submitted: January 26, 2018)
25
Estimated Study Completion Date  ICMJE October 16, 2021
Estimated Primary Completion Date October 16, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Males ≥ 18 years of age on the day of consenting to the study.
  2. Ability to swallow the study drug as a whole tablet.
  3. Histologically confirmed prostate adenocarcinoma without significant small- cell/neuroendocrine or other variant histologies, with rising PSA and/or radiographic progression in the setting of castration-level testosterone (< 50 ng/dL) indicating mCRPC. Patients must have either undergone surgical castration or continue on GnRH agonist/antagonist on the appropriate schedule throughout the study period.
  4. Asymptomatic or minimally symptomatic disease.
  5. Metastatic disease by bone scan or other nodal or visceral lesions on CT or MRI at any time (past or present).
  6. Subject currently receiving abiraterone and prednisone for CRPC.
  7. Subject has been on abiraterone for castration-sensitive prostate cancer (CSPC) or castration-resistant prostate cancer (CRPC). Subjects who have received abiraterone for CSPC must have had a response to hormonal therapy, as defined by any decline in PSA, radiographic response and/or clinical benefit after starting hormonal therapy.

    Subjects who have received abiraterone for CRPC must have responded to abiraterone, defined by any decline in PSA, radiographic response, and/or clinical benefit after starting abiraterone.

  8. Two rising PSA values separated by at least 1 week, one showing a rise of at least 0.5 ng/mL and one confirmatory value not showing a decline, while on abiraterone therapy.
  9. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
  10. Subject has adequate bone marrow and organ function as shown by:

    • Absolute neutrophil count (ANC) ≥ 1.0 x 109/L
    • Platelets ≥ 100 x 109/L
    • Hemoglobin (Hgb) ≥ 9.0 g/dL
    • Serum creatinine ≤ 2 x the upper limit of normal (ULN)
    • Total serum bilirubin ≤ 1.5 x ULN (in subjects with known Gilbert Syndrome, a total bilirubin ≤ 3.0 x ULN, with direct bilirubin ≤ 1.5 x ULN)
    • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x ULN (or ≤ 5.0 x ULN if hepatic metastases are present)

Exclusion Criteria:

  1. Major surgery within 28 days prior to starting study drug or has not recovered from major side effects of the surgery.
  2. Rapidly progressive symptoms of mCRPC.
  3. Acute neurological dysfunction as a result of bone metastasis.
  4. Previously treated with enzalutamide or experimental therapies directed against androgen receptor (ie, apalutamide).
  5. Use of any chemotherapy, investigational agents, immunotherapy, or hormonal therapy other than GnRH agonists within 28 days of the start of treatment on protocol.

    Use of bone targeted agents including bisphosphonates and RANK ligand inhibitors is allowed if on stable dose; Xgeva or Zometa cannot be started within 28 days of initiating study therapy.

  6. Systemic corticosteroids except as part of on label treatment prostate cancer regimens. Note: Topical applications (eg, rash), inhaled sprays (eg, obstructive airways diseases), eye drops or local injections (eg, intra-articular) are allowed.
  7. Treatment with any of the drugs listed in Section 8.4.5 at the time of study treatment initiation.
  8. Has received wide field radiotherapy (including therapeutic radioisotopes such as radium 223) ≤ 28 days or limited field radiation for palliation ≤ 14 days prior to starting study drug or has not recovered from side effects of such therapy.
  9. New York Heart Association (NYHA) Class III or IV heart disease, active ischemia or any other uncontrolled cardiac condition, or hypertensive or metabolic condition.
  10. Myocardial infarction in the previous 12 weeks (from the start of treatment)
  11. QT interval with Fridericia's correction [QTcF] >470 milliseconds. The QTcF should be calculated as the arithmetic mean of the QTcF on triplicate ECGs. In the case of potentially correctible causes of QT prolongation (e.g., medications, hypokalemia), the triplicate ECG may be repeated once during screening and that result may be used to determine eligibility.
  12. Planned concomitant use of medications known to prolong the QT/QTc interval
  13. Presence of risk factors for torsade de pointes, including family history of Long QT Syndrome or uncorrected hypokalemia.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Central Contact Lead 858-952-7652 VKelemen@trovagene.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03414034
Other Study ID Numbers  ICMJE TROV-053
U1111-1208-1579 ( Registry Identifier: WHO )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Trovagene, Inc.
Study Sponsor  ICMJE Trovagene, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Trovagene, Inc.
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP