Approval Probability
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Also known as apatorsen
OGX-427 · 6 trials · 9 indications
The primary efficacy endpoint is defined as the proportion of patients without disease progression at the 12-week evaluation after treatment with prednisone given with or without OGX-427.
Overall survival defined as the time, in months, from date of randomization until date of death or date last known alive whichever comes first, assessed up to 2 years.
Defined as the time (in months) from date of randomization to the date of first observation of progression based on radiological assessment by Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1, or date of death from any cause, in the absence of progressive disease (PD) or censored at the date of last adequate tumor assessment. Progressive Disease is defined by RECIST v1.1 as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest (nadir) sum while on study (this includes the baseline sum if that is the smallest on study), or the appearance of one or more new lesions.
OS is defined as the time from randomization to death from any cause; OS was censored on date of last contact for participants still alive at time of analysis.
| Arm | Type | Description |
|---|---|---|
| OGX-427 and Prednisone | EXPERIMENTAL | OGX-427: Starting within 5 days of randomization, three loading doses at 600 mg IV within the first 10 days of initiating treatment, followed by weekly doses of 1000 mg IV Prednisone: 5 mg BID orally starting within 4 days following randomization and at least 24 hours prior to first loading dose of OGX-427 |
| Prednisone | ACTIVE_COMPARATOR | Control Arm: Prednisone: 5 mg BID orally starting within 4 days following randomization |
| OGX-427 | EXPERIMENTAL | Three loading doses of OGX-427 at 600mg IV will be administered Days -9 to -1. Following the loading dose period, OGX-427 will be administered at 600mg IV weekly Days 1, 8, 15, and 22 of each 28 day cycle during the Treatment Phase. |
| Placebo | PLACEBO_COMPARATOR | Three loading doses of placebo will be administered Days -9 to -1. Following the loading dose period, placebo will be administered weekly Days 1, 8, 15, and 22 of each 28 day cycle. |
| Experimental Arm: Arm A | EXPERIMENTAL | Three doses of 600 mg OGX-427 will be administered IV during the loading dose period (days -9 to -1). Following completion of the loading dose period, 600 mg OGX-427 will be given IV weekly on days 1, 8, and 15 of each 21-day cycle. |
| Control Arm: Arm B | ACTIVE_COMPARATOR | Docetaxel (75 mg/M2) will be administered IV on day 1 of each 21 day cycle for a maximum of 10 cycles. |
| OGX-427 600 mg | EXPERIMENTAL | Standard chemotherapy (gemcitabine and cisplatin) in combination with OGX-427 (600 mg) |
| OGX-427 1000 mg | EXPERIMENTAL | Standard chemotherapy (gemcitabine and cisplatin) in combination with OGX-427 (1000 mg) |
| A | EXPERIMENTAL | Each patient receives OGX-427 |
| Name | Type | Description |
|---|---|---|
| OGX-427 | DRUG | OGX-427: Starting within 5 days of randomization, three loading doses at 600 mg IV within the first 10 days of initiating treatment, followed by weekly doses of 1000 mg IV |
| Prednisone | DRUG | Control Arm: Prednisone: 5 mg BID orally starting within 4 days following randomization Experimental Arm: Prednisone: 5 mg BID orally starting within 4 days following randomization and at least 24 hours prior to first loading dose of OGX-427 |
| Placebo | DRUG | Three separate administrations of Placebo will be given during the 9-day Loading Dose Period. Following the Loading Dose Period, patients will receive placebo prior to the administration of nab-paclitaxel (125mg/m2 IV)and gemcitabine (1000mg/m2 IV)administration on Day 1, 8, and 15 of each cycle. Placebo will also be administered on Day 22 during each cycle (i.e., weekly). Patients will continue 28 day treatment cycles until disease progression or until other reasons for discontinuation from treatment. |
| Docetaxel | DRUG | For Arm A Only: Docetaxel should be administered immediately following the completion of the OGX-427 infusion. For Both Arms: Docetaxel (75 mg/M2) will be administered IV on Day 1 of each 21 day cycle for a maximum of 10 cycles. |
| OGX-427 600 mg | DRUG | Patients will receive three loading doses of 600 mg Study Drug within a 9-day period. Following the loading dose period, patients will receive weekly Study Drug infusions (600 mg IV) on Days 1, 8 and 15 of each 21-day cycle. |
| OGX-427 1000 mg | DRUG | Patients will receive three loading doses of 600 mg Study Drug within a 9-day period. Following the loading dose period, patients will receive weekly Study Drug infusions (1000 mg IV) on Days 1, 8 and 15 of each 21-day cycle. |
| Gemcitabine | DRUG | Patients will receive gemcitabine (1000 mg/m\^2) for up to 6 cycles administered IV on Days 1 and 8 of each 21-day cycle following Study Drug infusion. The Cycle 1, Day 1 administration of chemotherapy must occur within 5 days of the third loading dose of Study Drug. |
| Cisplatin | DRUG | Following the administration of gemcitabine on Day 1, cisplatin (70 mg/m\^2) will be administered IV for up to 6 cycles. The Cycle 1, Day 1 administration of chemotherapy must occur within 5 days of the third loading dose of Study Drug. |
| Carboplatin | DRUG | Following the administration of gemcitabine on Day 1, cisplatin (70 mg/m\^2) is to be administered IV for up to 6 cycles; however, carboplatin could be substituted for cisplatin for some unacceptable toxicities. The Cycle 1, Day 1 administration of chemotherapy must occur within 5 days of the third loading dose of Study Drug. |
Inclusion Criteria * Age ≥ 18 years on the date of consent. * ECOG performance status of 0 or 1. * Histological or cytological diagnosis of adenocarcinoma of the prostate. * Metastatic disease on chest, abdominal, or pelvic CT and/or bone scan for which no curative therapy exists. * Progression of ...
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OGX-427 is an investigational small molecule oncology drug developed by Achieve Life Sciences, Inc. It has been studied in Phase 2 clinical trials across several cancer types, including bladder cancer, castration resistant prostate cancer, pancreatic cancer, and non squamous non small cell lung cancer. It is not an approved therapy.
OGX-427 targets Hsp27, a protein in the heat shock protein family. By binding to and reducing Hsp27, the drug is designed to interfere with a protein that helps cancer cells survive treatment stress. Hsp27 is classified as a protein target, and the drug is a small molecule.
OGX-427 is developed by Achieve Life Sciences, Inc., which trades on the Nasdaq under the ticker ACHV. The company sponsored the Phase 2 studies of the drug in pancreatic cancer, non small cell lung cancer, and bladder cancer.
OGX-427 is in Phase 2 development. All of its recorded trials are Phase 2 studies, and all of them are completed, with no active trials currently listed. It is an investigational agent and has not been approved by the FDA for any indication.
OGX-427 has been evaluated in completed Phase 2 trials including NCT01844817 in metastatic pancreatic cancer, NCT01829113 in untreated stage IV non squamous non small cell lung cancer, NCT01780545 in relapsed or refractory metastatic bladder cancer, and NCT01454089 in bladder cancer. These studies were randomized and active controlled.