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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02266745
Recruitment Status : Recruiting
First Posted : October 17, 2014
Last Update Posted : December 8, 2021
Sponsor:
Information provided by (Responsible Party):
Promontory Therapeutics Inc.

Brief 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 its safety and tolerability, and PK (pharmacokinetics).

The Dose Escalation Phase is 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, and one cohort for the study of PT-112 in metastatic castrate-resistant prostate cancer (mCRPC).


Condition or disease Intervention/treatment Phase
Advanced Solid Tumors CRPC mCRPC Metastatic Castrate-resistant Prostate Cancer PT-112 Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Drug: PT-112 Injection Phase 2

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 no longer enrolling.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Subjects enrolled in Cohort D Part 2 will be randomized.
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : July 2014
Estimated Primary Completion Date : July 1, 2022
Estimated Study Completion Date : December 31, 2022

Arm Intervention/treatment
Experimental: Arm 1: PT-112 injection
Arm 1: PT-112 Injection, administered by intravenous infusion, 360 mg/m2
Drug: PT-112 Injection
Other Name: PT-112

Experimental: Arm 2: PT-112 injection
Arm 2: PT-112 Injection, administered by intravenous infusion, 250 mg/m2
Drug: PT-112 Injection
Other Name: PT-112




Primary Outcome Measures :
  1. 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. [ Time Frame: 28-day cycle ]
    Cohort D only


Secondary Outcome Measures :
  1. Disease Control Rate by disease manifestation, evaluated using PCWG3-modified RECIST criteria [ Time Frame: up to 24 months ]
    Cohort D only

  2. Objective Response Rate (ORR) in patients with RECIST-measurable disease, evaluated using PCWG3-modified RECIST criteria [ Time Frame: up to 24 months ]
    Cohort D only

  3. Median duration of response (DOR) as defined by PCWG3-modified RECIST criteria [ Time Frame: up to 24 months ]
    Cohort D only

  4. Percentage of patients achieving PSA50 as defined by PCWG3 criteria [ Time Frame: up to 24 months ]
    Cohort D only

  5. Median radiographic progression free survival (rPFS) by PCWG3 criteria [ Time Frame: up to 24 months ]
    Cohort D only

  6. Median overall survival (OS) [ Time Frame: up to 24 months ]
    Cohort D only

  7. Time to PSA progression by PCWG3 criteria [ Time Frame: up to 24 months ]
    Cohort D only

  8. Change in disease related pain based on ACS Daily Pain Diary assessment [ Time Frame: up to 24 months ]
    Cohort D only



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Pathologically confirmed advanced solid tumor for which standard therapy proven to provide clinical benefit does not exist or is no longer effective.
  • 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.
  • Willing and able to provide written Informed Consent and comply with the requirements of the study.

Key Exclusion Criteria:

  • 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.
  • Presence of an acute or chronic toxicity of prior chemotherapy, that has not resolved to ≤Grade 1, as determined by CTCAE v 4.0.
  • Receipt of more than 3 prior regimens of cytotoxic chemotherapy for metastatic disease.
  • Bone marrow reserve which is not adequate for participation in this trial.
  • Radiotherapy within 28 days prior to baseline.
  • Fraction of radiotherapy to >25 % of bone marrow.
  • Major surgery within 28 days prior to initiation of study drug.
  • Active bacterial, viral, or fungal infection requiring systemic therapy.
  • Known human immunodeficiency virus or acquired immunodeficiency syndrome related illness.
  • Clinically significant hearing impairment, as judged by the Principal Investigator.
  • Uncontrolled cardiovascular abnormalities.
  • Previous malignancy, except for non-squamous-cell carcinoma of skin or carcinoma in-situ of the uterine cervix, unless the tumor was treated with curative intent more than 2 years prior to study entry.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02266745


Contacts
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Contact: Phosplatin Therapeutics clinops@phosplatin.com

Locations
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United States, Arizona
Arizona Recruiting
Phoenix, Arizona, United States, 85054
United States, Colorado
Colorado Recruiting
Aurora, Colorado, United States, 80045
United States, Florida
Jacksonville Recruiting
Jacksonville, Florida, United States, 32224
United States, Massachusetts
Boston Recruiting
Boston, Massachusetts, United States, 02215
United States, Minnesota
Rochester Recruiting
Rochester, Minnesota, United States, 55905
United States, New York
Brooklyn Not yet recruiting
Brooklyn, New York, United States, 11215
New York Recruiting
New York, New York, United States, 10065
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Daniel D. Karp, MD         
United States, Washington
Seattle Recruiting
Seattle, Washington, United States, 19024
Sponsors and Collaborators
Promontory Therapeutics Inc.
Investigators
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Principal Investigator: Daniel D. Karp, MD M.D. Anderson Cancer Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Promontory Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT02266745    
Other Study ID Numbers: PT-112-101
First Posted: October 17, 2014    Key Record Dates
Last Update Posted: December 8, 2021
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Keywords provided by Promontory Therapeutics Inc.:
PT-112
Additional relevant MeSH terms:
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Prostatic Neoplasms
Neoplasms
Neoplasms by Site
Urogenital Neoplasms
Genital Neoplasms, Male
Prostatic Diseases