Phase 2 Study of G-202 in Patients With Chemotherapy-Naïve Metastatic Castrate-Resistant Prostate Cancer

NCT01734681 | Withdrawn Phase 2

• 1 other identifier: G202-002
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Prostate cancer that has returned after local treatment usually responds to hormone blocking treatment, but most patients eventually experience disease progression. Further chemotherapy does not normally lead to a cure or dramatic improvement in the disease and there is a need to identify new drugs that are beneficial for these patients without unacceptable side effects. Prodrug chemotherapy is an approach in which an inactive non-toxic agent is administered to the patient and gets activated within the body at specific locations, resulting in a higher concentration of the cytotoxic form at a tumour location whilst avoiding general side effects. G-202 is an example of prodrug chemotherapy. It does not have many general side effects because it is converted to a cell toxin only at the tumour or other specific locations in the body. G-202 is activated by Prostate Specific Memory Antigen (PSMA), a substance expressed by prostate cancer cells and in the blood vessels of most solid tumours, but not by normal cells or blood vessels in normal tissue. It is believed that activation of the prodrug G-202 will allow the drug to kill cancer cells, particularly prostate cancer cells. This study will evaluate the activity and safety of G-202 in men with castration-resistant prostate cancer (CRPC), which means the cancer has progressed after hormone blocking treatment, but who have not yet received chemotherapy and who have no or only a few symptoms from their CRPC. The study will evaluate clinical activity and safety of G-202 administered on three consecutive days of a 28-day cycle.

Conditions

Prostate Cancer.

Outcome Measures

Primary Outcomes (1)

• Percentage of patients who are progression-free after 24 weeks of treatment with G-202

  Determine the percentage of patients with chemotherapy-naïve metastatic castrate-resistant prostate cancer who do not have disease progression (radiographic or clinical) after 24 weeks of treatment with G-202

  24 weeks

Secondary Outcomes (7)

• Maximum prostatic specific antigen (PSA) change from baseline at any time

  Every 4 weeks

• Percent change in PSA from baseline to 24 weeks

  24 weeks

• Time to PSA progression

  Every 4 weeks

• PSA Doubling time

  Every 4 weeks

• Best Objective Response

  Every 12 weeks

Study Arms (1)

Treatment with G-202

EXPERIMENTAL

G-202 will be administered by intravenous infusion over one hour on Days 1, 2 and 3 of a 28-day treatment cycle. The G-202 dose will be 40 mg/m2 on Day 1 and 66.8 mg/m2 on Days 2 and 3.

Drug: G-202

Interventions

G-202 DRUG

Treatment with G-202

Eligibility Criteria

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

You may qualify if:

• Confirmed prostate adenocarcinoma
• Asymptomatic or minimally symptomatic
• Radiographic metastatic or recurrent disease
• Chemically- or surgically-castrated with disease progression
• Castrate testosterone level \<50 ng/dL
• Discontinued flutamide, bicalutamide and nilutamide
• Absence of known brain metastases
• Age ≥18 years
• Eastern Cooperative Oncology Group performance status ≤ 2
• Estimated life expectancy ≥ 6 months
• Adequate hematopoietic function as demonstrated by:
• hemoglobin of ≥ 9.0 g/dL without need for sustained blood transfusions
• platelet count ≥100,000 platelet/mm3 (100 x 109/L)
• White Blood Cell (WBC) count ≥ 2.0 x109/L and Absolute Neutrophil Count (ANC) ≥1.5 x109/L
• Adequate hepatobiliary function as demonstrated by:

You may not qualify if:

• Prior chemotherapy
• Other concurrent therapy for prostate cancer other than LHRH agonists or antagonists.
• Treatment with therapeutic radionucleotides within 12 weeks of study entry
• Radiation therapy \< 4 weeks before study entry
• Documentation of keratosis follicularis
• Pre-existing cardiac condition:
• use of inhibitors or inducers of cytochrome (CYP3A4) iso-enzymes
• Chronic use of opioids for cancer-related pain
• Corrected QT interval \> 470 msec
• Active uncontrolled infection, including known history of AIDS, hepatitis B or C
• Proteinuria level \> +2 on urine analysis

Sponsors & Collaborators

• GenSpera, Inc.: lead

Study Sites (1)

The University of Texas Health Science Center

San Antonio, Texas, 78229-3900, 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 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: November 19, 2012
• First Posted: November 28, 2012
• Study Start: May 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: February 19, 2014

Record last verified: 2013-02

Locations

US (1)