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

NCT02381236 | Completed Phase 2

• 1 other identifier: G-202-005
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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).

Conditions

Prostatic Neoplasms

Outcome Measures

Primary Outcomes (2)

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

  mpMRI performed after 3 cycles of treatment prior to prostatectomy

  12 weeks from first administration of G-202

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

  mpMRI performed after 3 cycles of treatment prior to prostatectomy

  12 weeks from first administration of G-202

Study Arms (1)

G-202

EXPERIMENTAL

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

Drug: G-202

Interventions

G-202 DRUG

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

Also known as: Mipsagargin

G-202

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GenSpera, Inc.: lead

Study Sites (1)

University of Texas Health Sciences Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Robert Amato, D.O.

  University of Texas Health Sciences Center at Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2015
• First Posted: March 6, 2015
• Study Start: February 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: February 1, 2017
• Last Updated: February 24, 2017

Record last verified: 2017-02

Locations

US (1)