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
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ClinicalTrials.gov Identifier: NCT02266745 |
Recruitment Status :
Recruiting
First Posted : October 17, 2014
Last Update Posted : December 8, 2021
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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 |
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.
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
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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
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Drug: PT-112 Injection
Other Name: PT-112 |
- 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
- Disease Control Rate by disease manifestation, evaluated using PCWG3-modified RECIST criteria [ Time Frame: up to 24 months ]Cohort D only
- 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
- Median duration of response (DOR) as defined by PCWG3-modified RECIST criteria [ Time Frame: up to 24 months ]Cohort D only
- Percentage of patients achieving PSA50 as defined by PCWG3 criteria [ Time Frame: up to 24 months ]Cohort D only
- Median radiographic progression free survival (rPFS) by PCWG3 criteria [ Time Frame: up to 24 months ]Cohort D only
- Median overall survival (OS) [ Time Frame: up to 24 months ]Cohort D only
- Time to PSA progression by PCWG3 criteria [ Time Frame: up to 24 months ]Cohort D only
- Change in disease related pain based on ACS Daily Pain Diary assessment [ Time Frame: up to 24 months ]Cohort D only

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

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
Contact: Phosplatin Therapeutics | clinops@phosplatin.com |
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 |
Principal Investigator: | Daniel D. Karp, MD | M.D. Anderson Cancer Center |
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 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
PT-112 |
Prostatic Neoplasms Neoplasms Neoplasms by Site |
Urogenital Neoplasms Genital Neoplasms, Male Prostatic Diseases |