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Advanced Solid TumorsPhase 2NCT02266745

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

A Phase 2 study testing PT-112 Injection in people with Advanced Solid Tumors and CRPC, run by Promontory Therapeutics Inc. at 25 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a Phase 1/2, open-label, multi-center, non-randomized, dose-escalation study to be conducted in two parts: the Dose Escalation Phase and the Dose Expansion Phase. The Dose Escalation Phase will determine the Maximum Tolerated Dose (MTD) and recommended Phase 2 dose(s) (RP2D) of PT-112 Injection and evaluate… Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Advanced Solid Tumors, CRPC, mCRPC
What is being tested?
PT-112 Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
109 participants
Where
25 sitesin 2 countries
Study dates
Jul 2014to 1 Apr 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male >/= 18 years of age
  • Histologically or cytologically confirmed adenocarcinoma of the prostate.
  • Document current evidence of metastatic castration-resistant prostate cancer (mCRPC), where metastatic status is defined as having documented metastatic lesion(s) on either bone scan or CT/MRI scan.
  • Patients who have received at least three prior intended life-prolonging therapies for metastatic disease.
  • Eastern Collaborative Oncology Group (ECOG) Performance Status of 0-1.
  • Progressive disease, either measurable on physical examination or imaging by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) or PCWG3 or by informative tumor marker(s).
  • Adequate organ function based on laboratory values.
  • If there is a known history of brain metastases, either treated or untreated, the disease must be stable.

Who cannot join

  • Any cytotoxic chemotherapy within 21 days prior to initiation of study drug.
  • Any immunomodulatory drug therapy, anti-neoplastic hormonal therapy, immunosuppressive therapy, corticosteroids, or growth factor treatment within 14 days prior to initiation of study drug.
  • Bone marrow reserve which is not adequate for participation in this trial.
  • Radiotherapy within 14 days prior to baseline.
  • Fraction of radiotherapy to >25 % of active bone marrow.
  • Major surgery within 28 days prior to initiation of study drug.

Trial locations and contacts

25 sites in 2 countries.

25 sites in 2 countries

United States17 sites

  • Albuquerque

    Albuquerque, New Mexico, 87190

  • Colorado

    Aurora, Colorado, 80045

  • Boston

    Boston, Massachusetts, 02215

  • Brooklyn

    Brooklyn, New York, 11215

  • Duarte

    Duarte, California, 91010

  • Durham

    Durham, North Carolina, 27705

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • Indianapolis

    Indianapolis, Indiana, 46202

  • Jacksonville

    Jacksonville, Florida, 32224

  • Minneapolis

    Minneapolis, Minnesota, 55426

  • New York

    New York, New York, 10065

  • Omaha

    Omaha, Nebraska, 68130

  • Orlando

    Orlando, Florida, 32806

  • Arizona

    Phoenix, Arizona, 85054

  • Rochester

    Rochester, Minnesota, 55905

  • Seattle

    Seattle, Washington, 19024

  • Tucson

    Tucson, Arizona, 85719

Other trials in United States

France8 sites

  • Besançon

    Besançon

  • Bordeaux

    Bordeaux

  • Caen

    Caen

  • Clermont-Ferrand

    Clermont-Ferrand

  • Marseille

    Marseille

  • Nice

    Nice

  • Paris

    Paris

  • Rennes

    Rennes

Other trials in France

About this study

Official title: A Phase 1, Open-Label, Dose-Escalation 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

This is a Phase 1/2, open-label, multi-center, non-randomized, dose-escalation study to be conducted in two parts: the Dose Escalation Phase and the Dose Expansion Phase. The Dose Escalation Phase will determine the Maximum Tolerated Dose (MTD) and recommended Phase 2 dose(s) (RP2D) of PT-112 Injection and evaluate its safety and tolerability, and PK (pharmacokinetics).

The Dose Escalation Phase is complete and no longer enrolling.

The Dose Expansion Phase has two cohorts: one cohort for the study of PT-112 in patients with thymoma and thymic carcinoma (Cohort A), and one cohort for the study of PT-112 in metastatic castrate-resistant prostate cancer (mCRPC) (Cohort D).

Read the detailed description

This is a Phase 1/2, open-label, multi-center, non-randomized, dose-escalation study to be conducted in two parts: the Dose Escalation Phase, and the Dose Expansion Phase

The Dose Escalation Phase and the Dose Expansion Thymoma Cohort are complete and no longer enrolling.

The Dose Expansion Phase of the study of PT-112 in metastatic castrate-resistant prostate cancer (mCRPC) is open and enrolling.

Being tested
PT-112 Injection
Keywords
PT-112
Medical subject headings
Prostatic Neoplasms, Genital Neoplasms, Male, Urogenital Neoplasms, Neoplasms by Site

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PT-112 InjectionDrug

    Also called PT-112

Study groups in NCT02266745
Study groupRoleWhat they receive
Arm 1: PT-112 injectionExperimentalArm 1: PT-112 Injection, administered by intravenous infusion, biweekly 360 mg/m2
Receives: Drug: PT-112 Injection
Arm 2: PT-112 injectionExperimentalArm 2: PT-112 Injection, administered by intravenous infusion, biweekly 250 mg/m2
Receives: Drug: PT-112 Injection
Arm 3: PT-112 injectionExperimentalArm 3: PT-112 Injection, administered by intravenous infusion, 360 mg/m2 for two doses, 250 mg/m2 for subsequent doses
Receives: Drug: PT-112 Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Initial design: Comparison of two dose levels, administered on Days 1 and 15 of each 28-day cycle:

    [ ] Define the recommended dose level for PT-112 for pivotal studies based on the risk/benefit ratio across Arms 1, 2 and 3.

    Cohort D only

    Measured: 28-day cycle

  2. Modified design: Define the recommended dose and schedule for PT-112 for pivotal studies

    Define the recommended dose and schedule for PT-112 for pivotal studies.

    Cohort D only

    Measured: 28-day cycle

Secondary outcomes (10)

  1. Disease Control Rate by disease manifestation, evaluated using PCWG3-modified RECIST criteria

    Cohort D only

    Measured: up to 24 months

  2. Objective Response Rate (ORR) in patients with RECIST-measurable disease, evaluated using PCWG3-modified RECIST criteria

    Cohort D only

    Measured: up to 24 months

  3. Median duration of response (DOR) as defined by PCWG3-modified RECIST criteria

    Cohort D only

    Measured: up to 24 months

  4. Percentage of patients achieving PSA50 as defined by PCWG3 criteria

    Cohort D only

    Measured: up to 24 months

  5. Percentage of patients who are CTC nonzero at baseline and with 0 CTCs/mL in one or more post-baseline samples (i.e., CTC0)

    Cohort D only

    Measured: up to 24 months

  6. Percentage of patients who have ≥ 3 CTCs at baseline and ≤ 3 CTCs in one or more post-baseline samples (i.e., CTC conversion)

    Cohort D only

    Measured: up to 24 months

  7. Median radiographic progression free survival (rPFS) by PCWG3 criteria

    Cohort D only

    Measured: up to 24 months

  8. Median overall survival (OS)

    Cohort D only

    Measured: up to 24 months

  9. Time to PSA progression by PCWG3 criteria

    Cohort D only

    Measured: up to 24 months

  10. Change in disease related pain based on ACS Daily Pain Diary assessment

    Cohort D only

    Measured: up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Oct 2014 (estimated)
  2. Study startJul 2014
  3. Primary completion1 Aug 2024 (estimated)
  4. Study completion1 Apr 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Model description
Subjects enrolled in Cohort D Part 2 will be randomized.
Masking
None (open label)
Enrolment
109 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02266745
Sponsor's protocol ID
PT-112-101
Status last verified
Apr 2024
First submitted
13 Oct 2014
Last updated
5 Apr 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes

Publications

  • Karp DD, Camidge DR, Infante JR, Ames TD, Price MR, Jimeno J, Bryce AH. Phase I study of PT-112, a novel pyrophosphate-platinum immunogenic cell death inducer, in advanced solid tumours. EClinicalMedicine. 2022 May 27;49:101430. doi: 10.1016/j.eclinm.2022.101430. eCollection 2022 Jul.

    PubMed 35747193

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PT-112 Injection in people with Advanced Solid Tumors and CRPC, run by Promontory Therapeutics Inc. at 25 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in United States, France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Initial design: Comparison of two dose levels, administered on Days 1 and 15 of each 28-day cycle: (time frame: 28-day cycle). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02266745, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2024.

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