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A Phase 1 Study Evaluating the Safety, PK, and Clinical Effects of PT-112 in Subjects With Advanced Solid Tumors

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 : October 22, 2020
Sponsor:
Information provided by (Responsible Party):
Phosplatin Therapeutics

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 and is no longer enrolling. The Dose Expansion Phase currently has two cohorts: one for the study of PT-112 in patients with thymoma and thymic carcinoma, and the second in the study of PT-112 in metastatic castrate-resistant prostate cancer (mCRPC).

Condition or disease: Advanced Solid Tumors; Thymoma and Thymic Carcinoma; Metastatic Castrate Resistant Prostate Cancer (mCRPC) Intervention/treatment: Drug: PT-112 Injection Phase: Phase 1/2


Condition or disease Intervention/treatment Phase
Advanced Solid Tumors TET: Thymic Epithelia 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 1

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 is no longer enrolling. The Dose Expansion Phase is commencing in the study of PT-112 in metastatic castrate-resistant prostate cancer (mCRPC).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
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
Study Start Date : July 2014
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : October 31, 2021

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




Primary Outcome Measures :
  1. Determine the safety and tolerability, Dose Limiting Toxicity(ies) (DLT), Maximum Tolerated Dose (MTD), and recommended Phase 2 dose(s) (RP2D) [ Time Frame: 28-day cycle ]
    The primary endpoint is to determine the safety profile and MTD of PT-112 Injection. Assessments will include drug exposure; characterization of DLTs; characterization of the type, incidence, severity, seriousness, and relationship to treatment of adverse events (AEs), and effects on vital signs and laboratory parameters.

  2. Assess the pharmacokinetic (PK) profile [ Time Frame: First 28-day cycle ]
    PK (pharmacokinetic) parameters, including but not limited to area under the curve (AUC), maximum plasma concentration (Cmax), trough plasma concentration (Cmin), time to maximum plasma concentration (Tmax), and plasma half-life (T1/2) will be determined.


Secondary Outcome Measures :
  1. Document any observed anti-tumor effects [ Time Frame: Day 1, Day 56 and every 56 days subsequently ]
    Subjects will be assessed for clinical activity of PT-112 Injection every 2 cycles by appropriate physical examination or computed tomography imaging techniques, using RECIST v1.1; and, where appropriate, informative tumor markers every cycle.



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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: Jason Summa (617) 335-1794 jsumma@phosplatin.com
Contact: Mariam Mahbob mmahbob@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
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         
Sponsors and Collaborators
Phosplatin Therapeutics
Investigators
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Principal Investigator: Daniel D. Karp, MD M.D. Anderson Cancer Center
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Responsible Party: Phosplatin Therapeutics
ClinicalTrials.gov Identifier: NCT02266745    
Other Study ID Numbers: PT-112-101
First Posted: October 17, 2014    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: October 2020

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