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Paclitaxel for Ovarian Cancer (PROFECTA-II Trial)
PROFECTA-II Trial Summary
This trial is testing a new cancer drug that works by inhibiting the AKT protein. The drug is being tested in combination with chemotherapy to see if it is effective in treating ovarian cancer that has become resistant to platinum-based drugs. So far, the drug appears to be safe and effective in this small study.
PROFECTA-II Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowPROFECTA-II Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2014 Phase 4 trial • 32 Patients • NCT01301729PROFECTA-II Trial Design
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Who is running the clinical trial?
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- I have not had a severe infection related to AIDS in the last 6 months.I have no health issues that prevent me from taking paclitaxel.I have not had any active cancer except for skin cancer or in situ cancer in remission in the last 3 years.I haven't had serious heart issues or strokes in the last 6 months.My digestive system can absorb medications properly.I agree to tests for specific cancer markers and can provide a recent or new tumor sample.Side effects from my previous treatments, except for hair loss, are mild or gone.I have ovarian cancer and have had 1-5 chemotherapy treatments, with only one after PROC diagnosis.I am not on strong HIV medication.My cancer got worse or came back within a month after my first platinum-based treatment.I have not had radiotherapy in the last 15 days, except for one session for symptom relief.I do not have active hepatitis B or C.I haven't taken chemotherapy, PARP inhibitors, bevacizumab, or experimental drugs recently.My kidney function, measured by creatinine levels, is within the normal range.I haven't taken strong CYP3A4/5 inhibitors or inducers for at least 2 weeks.I have a history of serious heart rhythm problems.My HIV medication might affect the study drug.My blood pressure is controlled and does not exceed 160/100 mmHg.I can take care of myself and am up and about more than 50% of my waking hours.I have not had major surgery in the last 30 days.I have never taken AKT, PI3K, or mTOR inhibitors.I have a condition that could lead to seizures or have brain-related issues needing medication.I have or might have cancer spread to my brain.My heart's electrical activity (QTc) is too long, and I take medications that I can't stop which may affect this.I had hepatitis B in the past but it's resolved now.My ovarian cancer returned 1-6 months after platinum therapy.I am a woman over 18 and can sign and follow the consent form.My doctor thinks weekly paclitaxel treatment is suitable for me.I have fluid buildup in my abdomen that isn't responding to treatment.I have severe nerve pain or damage.My cancer is a specific type of ovarian cancer, not including low-grade or mucinous types.I have had treatment for spinal cord compression and my condition is stable.My liver function tests are within the required range.
- Group 1: Arm 1
- Group 2: Arm 2
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What therapeutic purposes does Paclitaxel serve?
"Paclitaxel has been used to successfully treat neoplasm metastasis, Kaposi sarcoma, and advanced directives."
Is enrollment currently open for this medical trial?
"Affirmative. Data hosted on clinicaltrials.gov testifies to the recruitment of participants for this medical trial, which was first posted on June 9th 2020 and recently updated on July 28th 2022. 141 patients are required from 31 different sites around the world."
Has Paclitaxel been given the stamp of approval by the US Food and Drug Administration?
"Paclitaxel's safety has been partially established in past clinical trials, which is why it was assigned a score of 2. There are currently no studies exploring the efficacy of Paclitaxel."
What are the aggregate numbers of participants for this research endeavor?
"In order for this clinical trial to begin, 141 suitable patients need to be found. Laekna Limited will administer the study from Holy Name Medical Center in Teaneck, New jersey and Arizona Oncology Associates in Phoenix, Arizona."
When have scientists previously tested Paclitaxel in a research setting?
"Paclitaxel was initially studied in 1997 at City of Hope Comprehensive Cancer Center. Since then, 1152 clinical trials have been completed while 833 are still ongoing; many of these trials take place in Teaneck, New jersey."
How widespread is the implementation of this research project in Canada's healthcare institutions?
"This clinical trial is open for enrolment at a staggering 31 sites, with locations in Teaneck, Phoenix and Tucson as well as 28 other cities. To minimise travel costs participants should endeavour to register at the closest location available."
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