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G-202 in the Neoadjuvant Setting Followed by Radical Prostatectomy in Patients With Prostate Cancer

Primary Purpose

Prostatic Neoplasms

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

G-202

About this trial

This is an interventional treatment trial for Prostatic Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

ECOG Performance Status < 2
Histological confirmation of prostatic adenocarcinoma that is confined to the prostate without evidence of regional and/or distant metastasis
Clinical stage T1c or T2a with high-grade disease (Gleason 8-10) on initial biopsy, clinical stage T2b-T2c with Gleason grade 7 (4+3), or clinical stage T3
Negative bone scan and CT of chest and abdomen within 6 weeks of first infusion of G-202
Candidate for radical prostatectomy
Adequate hematologic function (ANC ≥ 1200/mm3, hemoglobin ≥ 8.5 g/dL, platelets ≥ 75,000/mm3)
Adequate hepatic function (albumin ≥ 2.8 g/dL, AST and ALT ≤ 5 x ULN, total bilirubin < 2 mg/dL)
Adequate renal function (proteinuria level ≤ 2+, serum creatinine ≤ 1.5 x ULN)
Acceptable coagulation profile (no history of substantial non-iatrogenic bleeding diatheses, INR ≤ 2.3, aPTT ≤ 1.5 x ULN)
Ejection fraction (LVEF) ≥ 45% measured by echocardiogram
Willing to use acceptable methods of contraception to avoid pregnancy

Exclusion Criteria:

Prostatic adenocarcinoma with neuroendocrine differentiation or small cell features
Unable to tolerate mpMRI
Surgical resection or major surgery within 4 weeks or stereotactic biopsy within 1 week prior to first G-202 treatment
Previous or current hormonal treatment, chemotherapy, radiation therapy, immunotherapy, or other investigational status drug for prostatic adenocarcinoma
Currently requiring systemic administration of antibiotics or chronic administration of anti-viral agents
Use of anti-coagulants is limited to local use for control of central line patency
History or evidence of cardiac risk
Uncontrolled cardiac or coronary artery disease
Uncontrolled hypertension or hypertension requiring treatment with more than 2 anti-hypertensive agents
Severe or uncontrolled medical disease
Severe gastrointestinal bleeding within 12 weeks prior to treatment with G-202
Known history of HIV, hepatitis B or hepatitis C
Use of herbal products that may decrease PSA levels (e.g., saw palmetto) or systemic corticosteroids
Documentation of keratosis follicularis
Requirement for chronic use of medications known to be strong inhibitors or inducers of cytochrome (CYP3A4) iso-enzymes
Another primary malignancy, except non-melanoma skin cancer, that has not been in remission for at least 2 years.

Sites / Locations

University of Texas Health Sciences Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

G-202

Arm Description

G-202 administered by intravenous infusion on 3 consecutive days of a 28-day cycle

Outcomes

Primary Outcome Measures

Volume of the prostate using multiparametric prostate magnetic resonance imaging (mpMRI)

mpMRI performed after 3 cycles of treatment prior to prostatectomy

Perfusion of the prostate using multiparametric prostate magnetic resonance imaging (mpMRI)

mpMRI performed after 3 cycles of treatment prior to prostatectomy

Secondary Outcome Measures

Full Information

NCT ID

NCT02381236

First Posted

February 23, 2015

Last Updated

February 22, 2017

Sponsor

GenSpera, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02381236

Brief Title

G-202 in the Neoadjuvant Setting Followed by Radical Prostatectomy in Patients With Prostate Cancer

Official Title

G-202-005: An Open-Label, Single-Arm, Phase II Study to Evaluate the Safety and Activity of G-202 Administered in the Neoadjuvant Setting Followed by Radical Prostatectomy in Patients With Adenocarcinoma of the Prostate

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Completed

Study Start Date

February 2016 (undefined)

Primary Completion Date

December 2016 (Actual)

Study Completion Date

February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GenSpera, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

A single-arm, open-label Phase II clinical trial to evaluate the effect of G-202 on the perfusion and volume of the prostate using non-invasive multiparametric prostate magnetic resonance imaging (mpMRI).

Detailed Description

More than one-third of patients with localized high-risk prostate cancer who undergo radical prostatectomy eventually relapse with distant disease and some data suggest that neoadjuvant treatment in this patient population may be helpful. This study is based on prodrug tumor targeting, in which an inactive form of a toxic agent is administered systemically and gets activated in specific locations in the body, resulting in higher concentrations of the cytotoxic form at the tumor location. G-202 is a prodrug that is activated in prostate cancer tissue and in the blood vessels of tumors, but not normal tissue; once activated, G-202 leads to disruption of intracellular calcium levels and subsequent induction of apoptosis. Thus, G-202 is expected to bring about cell death in prostate cancer cells and to destroy the blood supply of prostate tumors. G-202 has led to disease stabilization in some patients, but the drug has not been evaluated in the neoadjuvant setting. This single-arm, open-label Phase II clinical trial will evaluate the safety and activity of G-202 in patients with localized high-risk prostate cancer prior to radical prostatectomy. Through its effects on the neovasculature of tumors, G-202 is anticipated to disrupt the blood supply of the prostate tumor, resulting in decreased perfusion and subsequent tumor volume. The primary endpoint of this study is evaluation of G-202 on the perfusion and volume of the prostate using non-invasive multiparametric prostate magnetic resonance imaging (mpMRI).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostatic Neoplasms

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

G-202

Arm Type

Experimental

Arm Description

G-202 administered by intravenous infusion on 3 consecutive days of a 28-day cycle

Intervention Type

Drug

Intervention Name(s)

G-202

Other Intervention Name(s)

Mipsagargin

Intervention Description

G-202 administered by intravenous infusion on Days 1, 2 and 3 of each 28-day cycle for up to 3 cycles

Primary Outcome Measure Information:

Title

Volume of the prostate using multiparametric prostate magnetic resonance imaging (mpMRI)

Description

mpMRI performed after 3 cycles of treatment prior to prostatectomy

Time Frame

12 weeks from first administration of G-202

Title

Perfusion of the prostate using multiparametric prostate magnetic resonance imaging (mpMRI)

Description

mpMRI performed after 3 cycles of treatment prior to prostatectomy

Time Frame

12 weeks from first administration of G-202

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: ECOG Performance Status < 2 Histological confirmation of prostatic adenocarcinoma that is confined to the prostate without evidence of regional and/or distant metastasis Clinical stage T1c or T2a with high-grade disease (Gleason 8-10) on initial biopsy, clinical stage T2b-T2c with Gleason grade 7 (4+3), or clinical stage T3 Negative bone scan and CT of chest and abdomen within 6 weeks of first infusion of G-202 Candidate for radical prostatectomy Adequate hematologic function (ANC ≥ 1200/mm3, hemoglobin ≥ 8.5 g/dL, platelets ≥ 75,000/mm3) Adequate hepatic function (albumin ≥ 2.8 g/dL, AST and ALT ≤ 5 x ULN, total bilirubin < 2 mg/dL) Adequate renal function (proteinuria level ≤ 2+, serum creatinine ≤ 1.5 x ULN) Acceptable coagulation profile (no history of substantial non-iatrogenic bleeding diatheses, INR ≤ 2.3, aPTT ≤ 1.5 x ULN) Ejection fraction (LVEF) ≥ 45% measured by echocardiogram Willing to use acceptable methods of contraception to avoid pregnancy Exclusion Criteria: Prostatic adenocarcinoma with neuroendocrine differentiation or small cell features Unable to tolerate mpMRI Surgical resection or major surgery within 4 weeks or stereotactic biopsy within 1 week prior to first G-202 treatment Previous or current hormonal treatment, chemotherapy, radiation therapy, immunotherapy, or other investigational status drug for prostatic adenocarcinoma Currently requiring systemic administration of antibiotics or chronic administration of anti-viral agents Use of anti-coagulants is limited to local use for control of central line patency History or evidence of cardiac risk Uncontrolled cardiac or coronary artery disease Uncontrolled hypertension or hypertension requiring treatment with more than 2 anti-hypertensive agents Severe or uncontrolled medical disease Severe gastrointestinal bleeding within 12 weeks prior to treatment with G-202 Known history of HIV, hepatitis B or hepatitis C Use of herbal products that may decrease PSA levels (e.g., saw palmetto) or systemic corticosteroids Documentation of keratosis follicularis Requirement for chronic use of medications known to be strong inhibitors or inducers of cytochrome (CYP3A4) iso-enzymes Another primary malignancy, except non-melanoma skin cancer, that has not been in remission for at least 2 years.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Robert Amato, D.O.

Organizational Affiliation

University of Texas Health Sciences Center at Houston

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Texas Health Sciences Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

12. IPD Sharing Statement

Learn more about this trial

G-202 in the Neoadjuvant Setting Followed by Radical Prostatectomy in Patients With Prostate Cancer

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