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 |
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Recruitment Status :
Active, not recruiting
First Posted : October 17, 2014
Last Update Posted : April 5, 2024
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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 complete and 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 (Cohort A), and one cohort for the study of PT-112 in metastatic castrate-resistant prostate cancer (mCRPC) (Cohort D).
| 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 complete and 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 : | 109 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 : | August 1, 2024 |
| Estimated Study Completion Date : | April 1, 2025 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Arm 1: PT-112 injection
Arm 1: PT-112 Injection, administered by intravenous infusion, biweekly 360 mg/m2
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Drug: PT-112 Injection
Other Name: PT-112 |
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Experimental: Arm 2: PT-112 injection
Arm 2: PT-112 Injection, administered by intravenous infusion, biweekly 250 mg/m2
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Drug: PT-112 Injection
Other Name: PT-112 |
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Experimental: Arm 3: PT-112 injection
Arm 3: PT-112 Injection, administered by intravenous infusion, 360 mg/m2 for two doses, 250 mg/m2 for subsequent doses
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Drug: PT-112 Injection
Other Name: PT-112 |
- Initial design: Comparison of two dose levels, administered on Days 1 and 15 of each 28-day cycle: [ Time Frame: 28-day cycle ]
[ ] Define the recommended dose level for PT-112 for pivotal studies based on the risk/benefit ratio across Arms 1, 2 and 3.
Cohort D only
- Modified design: Define the recommended dose and schedule for PT-112 for pivotal studies [ Time Frame: 28-day cycle ]
Define the recommended dose and schedule for PT-112 for pivotal studies.
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
- Percentage of patients who are CTC nonzero at baseline and with 0 CTCs/mL in one or more post-baseline samples (i.e., CTC0) [ Time Frame: up to 24 months ]Cohort D only
- Percentage of patients who have ≥ 3 CTCs at baseline and ≤ 3 CTCs in one or more post-baseline samples (i.e., CTC conversion) [ 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
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Key Inclusion Criteria:
- Male >/= 18 years of age
- Histologically or cytologically confirmed adenocarcinoma of the prostate.
- Document current evidence of metastatic castration-resistant prostate cancer (mCRPC), where metastatic status is defined as having documented metastatic lesion(s) on either bone scan or CT/MRI scan.
- Patients who have received at least three prior intended life-prolonging therapies for metastatic disease.
- 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.
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.
- Bone marrow reserve which is not adequate for participation in this trial.
- Radiotherapy within 14 days prior to baseline.
- Fraction of radiotherapy to >25 % of active bone marrow.
- Major surgery within 28 days prior to initiation of study drug.
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
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| 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: | April 5, 2024 |
| Last Verified: | April 2024 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
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PT-112 |
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Prostatic Neoplasms Neoplasms Neoplasms by Site Urogenital Neoplasms Genital Neoplasms, Male Genital Diseases, Male |
Genital Diseases Urogenital Diseases Prostatic Diseases Male Urogenital Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications |