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| Sponsor: | Bellicum Pharmaceuticals |
|---|---|
| Collaborators: |
M.D. Anderson Cancer Center The Center for Clinical and Translational Sciences (CCTS) Clinical Research Unit at The University of Texas Health Science Center at Houston Memorial Hermann Hospital Baylor College of Medicine |
| Information provided by: | Bellicum Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00868595 |
Purpose
This is a Phase I/II, non-randomized, multiple-dose, 3+3 dose-escalation study of the safety, pharmacokinetics, biomarkers, preliminary efficacy and patient-reported outcomes of therapeutic vaccine, BPX-101 (formerly BP-GMAX-CD1), plus activating agent, AP1903, in patients with castrate resistant prostate cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Castrate Resistant Prostate Cancer (CRPC) |
Biological: BPX-101 Drug: AP1903 |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I/II, Non-randomized, Multiple Dose, Dose Escalation Study of the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Therapeutic Vaccine, BP-GMAX-CD1, Plus Activating Agent, AP1903, in Patients With Castrate Resistant Prostate Cancer |
| Estimated Enrollment: | 18 |
| Study Start Date: | April 2009 |
| Estimated Study Completion Date: | August 2011 |
| Estimated Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Every Other Week Schedule
Every Other Week Schedule: Cohort 1: BPX-101, 4 x 10*6 cells Cohort 2: BPX-101, 12.5 x 10*6 cells Cohort 3: BPX-101, 25 x 10*6 cells In Cohort 1 and Cohort 2, 1 mL of BP-GMAX-CD1 will be administered at each treatment visit as 5 intradermal (ID) injections (200 µL each). In Cohort 3, 1.6 mL of BP-GMAX-CD1 will be administered at each treatment visit as 8 intradermal (ID) injections (200 µL each). Each subject will receive an initial 6 doses, followed by boosters every 8 weeks for patients who do not progress. At 24 hours after each vaccination, a single dose of the activating agent, AP1903 for Injection, will be administered at a fixed dose of 0.4 mg/kg via intravenous (IV) infusion over 2 hours. |
Biological: BPX-101
Vaccine
Other Name: N/Ap
Drug: AP1903
Activating agent, infusion
Other Name: N/Ap
|
|
Experimental: Cohort 4
Cohort 4: BP-GMAX-CD1, 25 x 106 cells in 1.6 mL (as established as MTD in Cohort 3). In Cohort 4, 1.6 mL of BP-GMAX-CD1 will be administered at each treatment visit as 8 ID injections (200 µL each), once every 4 weeks for 3 cycles (Q4W x 3). For Cohort 4 only, at least 2 patients should be enrolled who had not received prior treatment with Taxotere, and at least 3 patients should be enrolled who had received prior treatment with Taxotere. |
Biological: BPX-101
Vaccine
Other Name: N/Ap
Drug: AP1903
Activating agent, infusion
Other Name: N/Ap
|
Patients will be screened within 6 weeks prior to Week 1. A total of 3 cohorts, consisting of 3 to 6 patients each, are planned to receive five to eight intradermal (ID) injections totaling 1 mL up to 1.6mL of BPX-101 at 3 doses levels for an initial 6 doses.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Other Criteria Apply however are not listed
Contacts and Locations| United States, Texas | |
| University of Texas Health Science Center Houston, CRU | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Guru Sonpavde, MD | University of Texas Health Science Center Houston - CCTS |
More Information
| Responsible Party: | Kevin Slawin, M.D. , Sponsor Representative, Bellicum Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT00868595 History of Changes |
| Other Study ID Numbers: | BP-PC-001 |
| Study First Received: | March 24, 2009 |
| Last Updated: | April 18, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Neoplasms Genital Diseases, Male Prostatic Diseases |