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PT-112 Injection for Advanced Prostate Cancer

Phase 2

Waitlist Available

Led By Daniel D. Karp, MD

Research Sponsored by Phosplatin Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically or cytologically confirmed adenocarcinoma of the prostate

Male >/= 18 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

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.

Who is the study for?

This trial is for adults with advanced solid tumors, including metastatic castrate-resistant prostate cancer, who have limited treatment options. Participants must be in good physical condition (ECOG 0-1), have stable brain metastases if present, and adequate organ function. They can't join if they've had extensive chemotherapy, uncontrolled heart issues, recent major surgery or radiotherapy, active infections or certain previous cancers.Check my eligibility

What is being tested?

The study tests PT-112 Injection's safety and how the body processes it. It has two parts: an initial phase to find the highest dose patients can tolerate without severe side effects (completed) and a second phase focusing on specific cancers like thymoma/thymic carcinoma and metastatic prostate cancer.See study design

What are the potential side effects?

Potential side effects of PT-112 are not detailed here but may include typical reactions to cancer treatments such as fatigue, nausea, blood count changes leading to increased infection risk or bleeding problems; organ-specific toxicity could also occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My prostate cancer was confirmed by a lab test.

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I am a man aged 18 or older.

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My prostate cancer has spread and is resistant to hormone therapy.

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I have undergone three or more treatments for my advanced cancer.

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I am fully active or can carry out light work.

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My cancer is growing, as shown by tests or markers.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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

+7 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: Arm 3: PT-112 injectionExperimental Treatment1 Intervention

Arm 3: PT-112 Injection, administered by intravenous infusion, 360 mg/m2 for two doses, 250 mg/m2 for subsequent doses

Group II: Arm 2: PT-112 injectionExperimental Treatment1 Intervention

Arm 2: PT-112 Injection, administered by intravenous infusion, biweekly 250 mg/m2

Group III: Arm 1: PT-112 injectionExperimental Treatment1 Intervention

Arm 1: PT-112 Injection, administered by intravenous infusion, biweekly 360 mg/m2

0 / 6Eligibility criteria met

Find a Location

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

Media Library

PT-112 Injection (Other) Clinical Trial Eligibility Overview. Trial Name: NCT02266745 — Phase 2

Prostate Cancer Research Study Groups: Arm 2: PT-112 injection, Arm 1: PT-112 injection, Arm 3: PT-112 injection

Prostate Cancer Clinical Trial 2023: PT-112 Injection Highlights & Side Effects. Trial Name: NCT02266745 — Phase 2

PT-112 Injection (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02266745 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there ample locations conducting this clinical experiment in the state?

"Various locations are partaking in the recruitment of patients, such as Indianapolis, Albuquerque and Durham. In total 12 different sites have opened their enrollment to this study."

Answered by AI

What is the target outcome of this experimental investigation?

"This 28-day clinical trial seeks to determine the optimal dose and schedule for PT-112 in preparation for pivotal studies. Specific secondary objectives include achieving an objective response rate (ORR) with RECIST-measurable diseases, attaining CTC0 from nonzero baseline measurements, and observing any anti-tumor effects through physical examinations or imaging techniques every two cycles."

Answered by AI

Has PT-112 Injection been given FDA authorization?

"With prior evidence suggesting its safety, PT-112 Injection was rated a 2 on the 1 to 3 scale. However, there is no available data confirming efficacy of this drug yet."

Answered by AI

Is recruitment for this experiment still ongoing?

"Data posted on clinicaltrials.gov confirms that the trial is actively recruiting subjects; it was first published on July 1st 2014 and last edited November 14th 2022."

Answered by AI

What is the upper limit of participants taking part in this medical experiment?

"This medical research necessitates the participation of 180 eligible individuals. Those who qualify can join from two sites, one in Indianapolis, Indiana and another in Albuquerque, New mexico."

Answered by AI

Recent research and studies

eClinicalMedicineJournal

Phase I Study of PT-112, a Novel Pyrophosphate-platinum Immunogenic Cell Death Inducer, in Advanced Solid Tumours

Karp, Daniel D., D. Ross Camidge, Jeffery R. Infante, Tyler D. Ames, Matthew R. Price, José Jimeno, and Alan H. Bryce. 2022. “Phase I Study of PT-112, a Novel Pyrophosphate-platinum Immunogenic Cell Death Inducer, in Advanced Solid Tumours”. Eclinicalmedicine. Elsevier BV. doi:10.1016/j.eclinm.2022.101430.

clinicaltrials.govStudy

A Study Evaluating the Safety, Pharmacokinetics, and Clinical Effects of Intravenously Administered PT-112 Injection in Subjects With Advanced Solid Tumors and Subsequent Dose Expansion Cohorts

2014. "A Study Evaluating the Safety, Pharmacokinetics, and Clinical Effects of Intravenously Administered PT-112 Injection in Subjects With Advanced Solid Tumors and Subsequent Dose Expansion Cohorts". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02266745.

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