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Trial record 1 of 2 for:    PT-112
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A Phase 1 Study of PT-112 Injection in Subjects With Advanced Solid Tumors

This study is currently recruiting participants.
See Contacts and Locations
Verified November 2016 by Phosplatin Therapeutics
Sponsor:
Information provided by (Responsible Party):
Phosplatin Therapeutics
ClinicalTrials.gov Identifier:
NCT02266745
First received: October 13, 2014
Last updated: November 9, 2016
Last verified: November 2016
  Purpose
This is a Phase I, open-label, multi-center, non-randomized, dose-escalation study to be conducted in two parts: the Dose Escalation Phase and the Dose Confirmation 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, PK (pharmacokinetic) and preliminary clinical effects. The Dose Confirmation Phase will be a cohort expansion at or below the MTD of PT-112 Injection. Subjects who tolerate the drug and who do not experience progressive disease may continue to receive PT-112 Injection at the discretion of the Principal Investigator for up to 6 cycles. For subjects who tolerate PT-112 Injection and who experience an objective response or stable disease through 6 cycles, the Sponsor will continue to provide PT-112 Injection under a separate mechanism, e.g., an extension protocol.

Condition Intervention Phase
Advanced Solid Tumors Drug: PT-112 Injection Phase 1

Study Type: Interventional
Study Design: 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

Further study details as provided by Phosplatin Therapeutics:

Primary Outcome Measures:
  • 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.

  • 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:
  • 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.


Estimated Enrollment: 80
Study Start Date: July 2014
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PT-112 injection
PT-112 Injection, administered by intravenous infusion
Drug: PT-112 Injection
Other Name: PT-112

Detailed Description:
This is a Phase I, open-label, multi-center, non-randomized, dose-escalation study to be conducted in two parts: the Dose Escalation Phase and the Dose Confirmation 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, PK (pharmacokinetic) and preliminary clinical effects. The Dose Confirmation Phase will be a cohort expansion at or below the MTD of PT-112 Injection. Subjects who tolerate the drug and who do not experience progressive disease may continue to receive PT-112 Injection at the discretion of the Principal Investigator for up to 6 cycles. For subjects who tolerate PT-112 Injection and who experience an objective response or stable disease through 6 cycles, the Sponsor will continue to provide PT-112 Injection under a separate mechanism, e.g., an extension protocol.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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 (Appendix 1).
  • Evaluable disease, either measurable on physical examination or imaging by Response Evaluation Criteria in Solid Tumors (RECIST v1.1, Appendix 2), or by informative tumor marker(s).
  • Laboratory values at the Screening Visit:

    1. Absolute neutrophil count (ANC) ≥1,500/mm3;
    2. Platelets ≥100,000/mm3;
    3. Total bilirubin ≤1.5 × the upper limit of normal (ULN) (subjects with Gilbert's Syndrome are allowed if direct bilirubin is within normal limits);
    4. Aspartate aminotransferase (AST [SGOT]) ≤2.5 × the ULN;
    5. Alanine aminotransferase (ALT [SGPT]) ≤2.5 × the ULN;
    6. Serum albumin ≥3.0 gm/dL;
    7. Serum creatinine ≤1.5 mg/dL or a measured creatinine clearance ≥60 mL/min; and Negative serum β hCG (human chorionic gonadotropin) test in women of childbearing potential (defined as women ≤50 years of age, or >50 years of age with a history of amenorrhea for ≤12 months prior to study entry).
  • Subjects with primary liver cancer or hepatic metastasis are eligible to enroll, provided that, at the Screening Visit, the following criteria are met:

    1. Total bilirubin is no higher than the ULN;
    2. AST and ALT are each ≤5 × the ULN;
    3. Severe liver dysfunction (Child-Pugh Class B or C) is not present; and
    4. Subjects with a history of esophageal bleeding have varices that have been sclerosed or banded and no bleeding episodes have occurred during the prior 6 months.
  • If there is a known history of brain metastases, either treated with radiation therapy or untreated, the metastatic disease must be stable in the judgment of the Principal Investigator and must not require ongoing treatment with corticosteroids or anticonvulsants.
  • 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 (unless dose has been stable for 3 months prior to Baseline and will remain stable during the trial), immunosuppressive therapy, corticosteroids >20 mg/day prednisone or equivalent, or growth factor treatment (e.g., erythropoietin) within 14 days prior to initiation of study drug.
  • Presence of an acute or chronic toxicity of prior chemotherapy, with the exception of alopecia, that has not resolved to ≤Grade 1, as determined by National Cancer Institute Common Toxicity Criteria for Adverse Effects (CTCAE) v 4.0 (http://evs.nci.nih.gov/ftp1/CTCAE/About.html).
  • Receipt of more than 3 prior regimens of cytotoxic chemotherapy for metastatic disease unless prior approval is granted by the Sponsor.
  • Bone marrow reserve which, in the clinical judgment of the Principal Investigator, is not adequate for participation in this trial.
  • Radiotherapy within 28 days prior to baseline.
  • Receipt of radiotherapy to >25 % of bone marrow.
  • Major surgery within 28 days prior to initiation of study drug.
  • Life expectancy <12 weeks.
  • 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 congestive heart failure (New York Heart Association Classification 3 or 4), angina, myocardial infarction, cerebrovascular accident, coronary/peripheral artery bypass graft surgery, transient ischemic attack, or pulmonary embolism within 3 months prior to initiation of study drug.
  • Unstable cardiac dysrhythmias or persistent prolongation of the corrected QT interval (QTc) (Fridericia) to >450 msec for males or >470 msec for females.
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02266745

Contacts
Contact: Bill Kovacs 919-792-3740 bkovacs@medsource.com

Locations
United States, Colorado
University of Colorado Cancer Center Recruiting
Aurora, Colorado, United States, 80045
Contact: Chalaunda Scott    720-848-1234    chalaunda.scott@ucdenver.edu   
Principal Investigator: Ross Camidge, MD, PhD         
United States, Tennessee
Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
Contact: Drug Development Unit    615-339-4214      
Principal Investigator: Jeffrey Infante, MD         
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Caitlin Ambrose, Study Coor.    713-794-5335    cambrose@mdanderson.org   
Contact: MD Anderson Cancer Center, General Info    1-855-873-4321      
Principal Investigator: Daniel D. Karp, MD         
Sponsors and Collaborators
Phosplatin Therapeutics
Investigators
Principal Investigator: Daniel D. Karp, MD M.D. Anderson Cancer Center
  More Information

Responsible Party: Phosplatin Therapeutics
ClinicalTrials.gov Identifier: NCT02266745     History of Changes
Other Study ID Numbers: PT-112-101
Study First Received: October 13, 2014
Last Updated: November 9, 2016

ClinicalTrials.gov processed this record on August 18, 2017