PTC-596 in Women With Ovarian Cancer Receiving Neoadjuvant Chemotherapy
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|ClinicalTrials.gov Identifier: NCT03206645|
Recruitment Status : Recruiting
First Posted : July 2, 2017
Last Update Posted : November 25, 2019
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer||Drug: PTC596||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||27 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||This trial will utilize a traditional 3+ 3 design with dose escalation.|
|Masking:||None (Open Label)|
|Official Title:||Phase 1B Trial With PTC-596 in High-Grade Serous Ovarian Cancer: a Targeted Approach Toward Chemoresistant Stem-Like Cancer Cells|
|Actual Study Start Date :||August 28, 2017|
|Estimated Primary Completion Date :||December 1, 2021|
|Estimated Study Completion Date :||February 1, 2024|
Experimental: Carboplatin/Paclitaxel + PTC596
Carboplatin AUC 6mg/L IV on day 1; Paclitaxel 175mg/m2 IV on day 1; PTC596 PO, twice a week, on day 1, 4, 8, 11, 15 and 18 per 21-day cycle for the first 3 cycles.
PTC596 will be given in combination with carboplatin and paclitaxel for up to 7 cycles depending on which cohort the patient is in.
- Maximum tolerated dose and dose limiting toxicities [ Time Frame: 42 days ]To determine the maximum tolerated dose (MTD) and dose limiting toxicities (DLTs) of PTC596 in combination with and following conventional chemotherapy and as maintenance as a capsule (weight-based dosing) and a tablet (fixed dosing). Standard chemotherapy will be comprised of carboplatin and weekly paclitaxel. The DLTs will be based on adverse events that occur during administration of the first 2 cycles of combination PTC596 and chemotherapy (a cycle = 21 days).
- Number of patients able to tolerate drug combination [ Time Frame: 3 years ]To examine the tolerability of the combination at the MTD of PTC596 assessed in combination with standard neoadjuvant chemotherapy.
- Phase 2 Dose [ Time Frame: 3 years ]To determine the recommended phase II dose (RP2D) of PTC596 in combination with standard neoadjuvant chemotherapy.
- Evaluate clinical response [ Time Frame: 3 years ]Evaluate clinical response by measuring serum CA-125. If CA-125 is initially above the upper normal limit, it must normalize for patients to be considered in complete clinical response.
- Evaluate pharmacokinetic Area Under the Curve (AUC) [ Time Frame: 3 months ]To evaluate pharmacokinetic parameters of PTC596 in patients with stage III or IV epithelial ovarian, primary peritoneal or fallopian tube cancer receiving neoadjuvant chemotherapy with carboplatin/paclitaxel
- Evaluate pharmacokinetic Maximum Concentration observed (Cmax) [ Time Frame: 3 months ]To evaluate pharmacokinetic parameters of PTC596 in patients with stage III or IV epithelial ovarian, primary peritoneal or fallopian tube cancer receiving neoadjuvant chemotherapy with carboplatin/paclitaxel
- Evaluate pharmacokinetic Time of Maximum Concentration observed (Tmax) [ Time Frame: 3 months ]To evaluate pharmacokinetic parameters of PTC596 in patients with stage III or IV epithelial ovarian, primary peritoneal or fallopian tube cancer receiving neoadjuvant chemotherapy with carboplatin/paclitaxel
- Evaluate pharmacokinetic half life (t1/2) [ Time Frame: 3 months ]
- Progression free survival [ Time Frame: one year ]The duration of time (one year) that patients are alive and their cancer is progression-free.
- Progression free survival [ Time Frame: two years ]The duration of time (two years) that patients are alive and their cancer is progression-free.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03206645
|Contact: Ingrid Block, RN||405 email@example.com|
|United States, Oklahoma|
|University of Oklahoma Health Sciences Center||Recruiting|
|Oklahoma City, Oklahoma, United States, 73104|
|Contact: Kathleen Moore, MD|
|Study Chair:||Kathleen Moore, MD||University of Oklahoma|