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PT-112 Injection for Metastatic Castrate-resistant Prostate Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Metastatic Castrate-resistant Prostate Cancer+8 MorePT-112 Injection - Drug
Eligibility
18+
Male
What conditions do you have?
Select

Study Summary

This trial is testing a new cancer drug, PT-112. It is in two parts, the first of which has finished enrolling. The second part is testing PT-112's safety and how well it works in patients with thymoma or thymic carcinoma, and in patients with metastatic castrate-resistant prostate cancer.

Eligible Conditions
  • Metastatic Castrate-resistant Prostate Cancer
  • Metastatic Castration-Resistant Prostate Cancer
  • Prostate Cancer
  • PT-112 Syndrome
  • Tumors
  • Urogenital Neoplasms
  • Advanced Solid Tumors
  • Castration-Resistant Prostate Cancer (CRPC)
  • Male Genital Neoplasms

Treatment Effectiveness

Effectiveness Progress

1 of 3

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1
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Study Objectives

5 Primary · 11 Secondary · Reporting Duration: up to 24 months

28-day cycle
Define the recommended dose level for PT-112, administered on Days 1 and 15 of each 28-day cycle, for pivotal studies based on the risk/benefit ratio of 360 mg/m2 (Arm 1) and 250 mg/m2 (Arm 2) dose levels.
Determine the safety and tolerability, Dose Limiting Toxicity(ies) (DLT), Maximum Tolerated Dose (MTD), and recommended Phase 2 dose(s) (RP2D)
Initial design: Comparison of two dose levels, administered on Days 1 and 15 of each 28-day cycle
Modified design: Define the recommended dose and schedule for PT-112 for pivotal studies
Day 56
Document any observed anti-tumor effects
First 28-day cycle
Assess the pharmacokinetic (PK) profile
up to 24 months
Change in disease related pain based on ACS Daily Pain Diary assessment
Disease Control Rate by disease manifestation, evaluated using PCWG3-modified RECIST criteria
Median duration of response (DOR) as defined by PCWG3-modified RECIST criteria
Median overall survival (OS)
Median radiographic progression free survival (rPFS) by PCWG3 criteria
Disease
Percentage of patients achieving PSA50 as defined by PCWG3 criteria
Percentage of patients who are CTC nonzero at baseline and with 0 CTCs/mL in one or more post-baseline samples (i.e., CTC0)
Circulating Neoplastic Cells
Time to PSA progression by PCWG3 criteria

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
CBD
1
ZN-c3
1
Venetoclax

Trial Design

3 Treatment Groups

Arm 2: PT-112 injection
1 of 3
Arm 3: PT-112 injection
1 of 3
Arm 1: PT-112 injection
1 of 3

Experimental Treatment

180 Total Participants · 3 Treatment Groups

Primary Treatment: PT-112 Injection · No Placebo Group · Phase 2

Arm 2: PT-112 injection
Drug
Experimental Group · 1 Intervention: PT-112 Injection · Intervention Types: Drug
Arm 3: PT-112 injection
Drug
Experimental Group · 1 Intervention: PT-112 Injection · Intervention Types: Drug
Arm 1: PT-112 injection
Drug
Experimental Group · 1 Intervention: PT-112 Injection · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 24 months

Who is running the clinical trial?

Phosplatin TherapeuticsLead Sponsor
2 Previous Clinical Trials
92 Total Patients Enrolled
Promontory Therapeutics Inc.Lead Sponsor
2 Previous Clinical Trials
92 Total Patients Enrolled
Daniel D. Karp, MDPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
1,772 Total Patients Enrolled

Eligibility Criteria

Age 18+ · Male Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are willing and able to provide written permission, as well as comply with the study's parameters.
You have satisfactory organ function according to laboratory results.
Your ECOG Performance Status is between 0 and 1.
You have advanced disease that can be determined by either physical assessment, imaging scans or through the evaluation of biomarkers.
If there is a documented record of cranial metastases, regardless of treatment status, the condition must be in abeyance.
You have a clinically verified advanced solid tumor for which there is no known effective standard treatment or it has become ineffective.
References

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