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 range

18 Years

Sex

FEMALE

See this in plain English?

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Analysis Report on the MTD In The Dose Escalation Portion Of The Study

Timeframe: 2 years

Best Overall Response Measured From, Start Of Treatment To The End

Timeframe: 13 months

Trial details

NCT IDNCT02661815

SponsorDana-Farber Cancer Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-06-28

Results submitted2019-04-16

View on ClinicalTrials.gov More Ovarian Cancer trials