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The purpose of this phase 2 study is to assess the efficacy and safety for adjuvant therapeutic cancer vaccine AST-201 (pUMVC3-hIGFBP-2) in patients with newly diagnosed homologous-recombination proficient(HRP) advanced ovarian cancer (Stage III) after debulking surgery. Patients will receive AST-201 with rhuGM-CSF(Colony Stimulating Factor) or placebo with rhuGM-CSF in combination with standard adjuvant chemotherapy(Paclitaxel/Carboplatin).
The study will comprise a screening period of -28 Days prior to initiation of study treatment (Day 1); an enrollment period of 24 months; the treatment duration will be approximately of 5 months.
The study will evaluate whether the addition of AST-201/rhuGM-CSF to the standard adjuvant chemotherapy will extend the Progression Free Survival(PFS) rate. Survival follow-up will be performed every 3 months (±14 days) after the End of treatment (EOT) visit for 2 years after randomization and every 6 months (±28 days) thereafter until disease progression or death from any cause or withdrawal of consent whichever comes first. Survival follow-up visits will be conducted by telephone, in-person visit, or chart review. The end of study (EOS) is defined as 2 years after the date of last patient enrollment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AST-301 | Experimental | AST-201 with rhuGM-CSF (3-week interval, 3 cycles in total) Standard chemotherapy (paclitaxel/carboplatin) (3-week interval, 6 cycles in total) * Both AST-201/rhuGM-CSF or Placebo/rhuGM-CSF will be given intradermally 2 weeks after each combination chemotherapy (on Day 15 of each cycle) for 3 cycles |
|
| Placebo | Placebo Comparator | Placebo with rhuGM-CSF (3-week interval, 3 cycles in total) Standard chemotherapy (paclitaxel/carboplatin) (3-week interval, 6 cycles in total) *Both AST-201/rhuGM-CSF or Placebo/rhuGM-CSF will be given intradermally 2 weeks after each combination chemotherapy (on Day 15 of each cycle) for 3 cycles |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AST-201 | Biological | i.d. (3-week interval, 3 cycles in total) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | the time from the date of randomization to disease progression, or death from any cause whichever occurs first | overall study duration (approximately 48 months) |
| Measure | Description | Time Frame |
|---|---|---|
| 2-year PFS rate | proportion of patients alive without disease progression or death at two years after the randomization | 24months from the first dose of AST-301 administration |
| Overall Survival (OS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hyunwon Shin, MD, PhD | Contact | +82-2-2038-2347 | hyunwon.shin@astonsci.com | |
| Eunkyo Joung, MD, CMO | Contact | +82-2-2038-2347 | eunkyo.joung@astonsci.com |
| Name | Affiliation | Role |
|---|---|---|
| Hyunwon Shin, MD, PhD | hyunwon.shin@astonsci.com | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington | Seattle | Washington | 98109 | United States |
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Single blind, randomized, placebo-controlled, multicenter, phase 2 clinical study
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Single blinded
| Paclitaxel | Drug | 3-week interval, 6 cycles in total |
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| Carboplatin | Drug | 3-week interval, 6 cycles in total |
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| Placebo | Drug | i.d. (3-week interval, 3 cycles in total) |
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| rhuGM-CSF(Granulocyte-Macrophage Colony-Stimulating Factor) | Drug | i.d. (3-week interval, 3 cycles in total) |
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the time from the date of randomization to death from any cause
| overall study duration (approximately 48 months) |
| AST-201 specific immunogenicity by Interferon gamma (IFN-gamma) enzyme-linked immunospot (ELISpot ) | AST-201 specific IFN-gamma ELISpot | 17months |
| Number of participants with Adverse events as graded by the National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] version 5.0) | Adverse events (AEs) Treatment-emergent adverse events (TEAEs) Serious adverse events (SAEs) Vital signs Physical examination Eastern Cooperative Oncology Group (ECOG) performance status Electrocardiogram (ECG) test Laboratory tests | 5 months |
| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D016190 | Carboplatin |
| D000077330 | Saline Solution |
| C081222 | sargramostim |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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