A Phase 1b Study of Paclitaxel And Ricolinostat For The Treatment Of Gynecological Cancer (NCT02661815) | Clinical Trial Compass
TerminatedPhase 1
A Phase 1b Study of Paclitaxel And Ricolinostat For The Treatment Of Gynecological Cancer
Stopped: Company decided not to move forward with further accrual.
United States6 participantsStarted 2016-06-15
Plain-language summary
Participants with Ovarian, Fallopian Tube, or Peritoneal Cancer that has recurred within 12 months of prior treatment that includes Platinum Chemotherapy are invited to take part in this study. This research study is studying a combination of a new chemotherapy drug called Ricolinostat together with the chemotherapy Paclitaxel and a drug called Bevacizumab as a possible treatment for this diagnosis.
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participants must have recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal carcinoma, recurrent endometrial cancer, or recurrent cervical cancer. Histologic documentation of the original primary tumor is required via the pathology report.
* Participants must have measurable disease by RECIST 1.1 criteria. See Section 11 for the evaluation of measurable disease.
* Participants must have had at least one prior platinum-based chemotherapeutic regimen for management of primary disease (e.g., a regimen containing carboplatin, cisplatin, or another organoplatinum compound). This initial treatment may have included intraperitoneal therapy, consolidation, biologic/targeted (non-cytotoxic) agents (e.g., bevacizumab) or extended therapy administered after surgical or non-surgical assessment.
Participants are allowed to receive, but are not required to receive, biologic/targeted (non-cytotoxic) therapy as part of their primary treatment regimen.
* Participants must have recurrence within 12 months of their last platinum-containing regimen.
* Age 18 years or older
* ECOG performance status 0 or 1
* Life expectancy of greater than 16 weeks
* Participants must have normal organ and marrow function as defined below:
* Leukocytes ≥3,000/mcL
* Absolute neutrophil count ≥1,500/mcL
* Platelets ≥100,000/mcL
* Total bilirubin within normal institutional limits
* AST(SGOT)/ALT(SGPT) ≤2.5 × institutional upper limit of normal
* Crea…
What they're measuring
1
Analysis Report on the MTD In The Dose Escalation Portion Of The Study
Timeframe: 2 years
2
Best Overall Response Measured From, Start Of Treatment To The End