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 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
Title
- Brief Title: A Phase 1 Study Evaluating the Safety, PK, and Clinical Effects of PT-112 in Subjects With Advanced Solid Tumors
- 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
Clinical Trial IDs
- ORG STUDY ID:
PT-112-101
- NCT ID:
NCT02266745
Conditions
- 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
Interventions
Drug | Synonyms | Arms |
---|
PT-112 Injection | PT-112 | PT-112 injection |
Purpose
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
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).
Trial Arms
Name | Type | Description | Interventions |
---|
PT-112 injection | Experimental | PT-112 Injection, administered by intravenous infusion | |
Eligibility 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.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | Male |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | 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 |
Safety Issue: | |
Description: | 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. |
Secondary Outcome Measures
Measure: | Document any observed anti-tumor effects |
Time Frame: | Day 1, Day 56 and every 56 days subsequently |
Safety Issue: | |
Description: | 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. |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Phosplatin Therapeutics |
Trial Keywords
Last Updated
October 22, 2020