Clinical trialPhase 1 / Phase 2Completed
Phase 1/2a DTA-H19 in Patients With Unresectable Pancreatic Cancer
Phase 1/2a, Dose-Escalation, Safety, Pharmacokinetic, and Preliminary Efficacy Study of Intratumoral Administration of DTA-H19 in Patients With Unresectable Pancreatic Cancer
- Outcome
- Outcome unknown
- Phase
- Phase 1 / Phase 2
- Status
- Completed
- Study type
- Interventional
- Start
- August 2009
- Expected end
- December 2010
- Enrollment
- 9 participants
- Sites
- 4
- Primary outcomes
- Maximal Tolerated Dose (MTD) & Dose Limiting Toxicity (DLT) of Intratumoral Injections of BC-819
- Sponsor
- Industry
- Results posted
- 2013-12-02
- Last update
- 20 March 2019
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Brief summary public domain (ClinicalTrials.gov)
This study is designed to assess the safety, tolerability, pharmacokinetics (PK) and preliminary efficacy of DTA-H19 administered intratumorally in patients with unresectable, locally advanced pancreatic cancer. Primary Objective: The primary objective is to determine the maximum tolerated dose (MTD) of intratumoral DTA-H19 and identify any dose limiting toxicities (DLTs). Secondary objectives include determining the adverse events (AEs) profile, effects on clinical laboratory analytes, vital signs, PK, tumor response, and possible tumor resectability after 4 intratumoral administrations of DTA-H19.
Detailed description public domain (ClinicalTrials.gov)
DTA-H19, is a doubled stranded DNA plasmid that carries the gene for the diphtheria toxn A (DT-A) chain under the regulation of the H19 promoter sequence. This is a Patient-Oriented, Targeted Therapy as DT-A chain expression is triggered by the presence of H19 transcription factors that are upregulated in tumor cells. The selective initiation of toxin expression results in selective tumor cell destruction via inhibition of protein synthesis in the tumor cell, enabling highly targeted cancer treatment.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Tumor Response [4 weeks]. Number, participants. Stable disease: BC-819 4 mg (n=3): 1; BC-819 8 mg (n=6): 4. Progressive disease: BC-819 4 mg (n=3): 2; BC-819 8 mg (n=6): 2.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Tumor Resectability [5 to 6 weeks]. Number, participants. BC-819 4 mg (n=3): 0; BC-819 8 mg (n=6): 1.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Maximal Tolerated Dose (MTD) & Dose Limiting Toxicity (DLT) of Intratumoral Injections of BC-819 [Week 4]. Number, participants. BC-819 4 mg (n=3): 0; BC-819 8 mg (n=6): 1.