Status:
ACTIVE_NOT_RECRUITING
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
Lead Sponsor:
Promontory Therapeutics Inc.
Conditions:
Advanced Solid Tumors
CRPC
Eligibility:
MALE
18+ years
Phase:
PHASE2
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 wil...
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 an...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2025
Estimated Enrollment :
109 Patients enrolled
Trial Details
Trial ID
NCT02266745
Start Date
July 1 2014
End Date
April 1 2025
Last Update
April 5 2024
Active Locations (25)
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1
Arizona
Phoenix, Arizona, United States, 85054
2
Tucson
Tucson, Arizona, United States, 85719
3
Duarte
Duarte, California, United States, 91010
4
Colorado
Aurora, Colorado, United States, 80045