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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
Must not have
Fraction of radiotherapy to >25 % of active bone marrow
Any cytotoxic chemotherapy within 21 days prior to initiation of study drug
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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More than 25% of my bone marrow has been exposed to radiation.
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I haven't had chemotherapy in the last 21 days.
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I have not had radiotherapy in the last 14 days.
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My bone marrow is not healthy enough for this trial.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

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
Genitourinary Cancers Research Study Groups: Arm 2: PT-112 injection, Arm 1: PT-112 injection, Arm 3: PT-112 injection
Genitourinary Cancers 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
~10 spots leftby Nov 2025
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