Your session is about to expire
← Back to Search
AKT Inhibitor
Paclitaxel for Ovarian Cancer (PROFECTA-II Trial)
Phase 2
Waitlist Available
Research Sponsored by Laekna Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
- Patients must have GI functions that would allow absorption of afuresertib.
The OC patients must have received 1 to 5 prior chemotherapies including no more than one chemotherapy after PROC was diagnosed. Combination therapy with two or more drugs will be considered as one therapy, whereas maintenance therapy will be considered as continuation of the previous systemic treatment.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline every 6 weeks × 30 weeks, then every 8 weeks through study completion, an average 1 year.
Awards & highlights
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.
Who is the study for?
This trial is for women aged 18+ with certain types of ovarian cancer that's resistant to platinum-based chemotherapy. They must have had 1-5 prior chemotherapies, be in good physical condition (ECOG 0-2), and not have brain metastases or other active cancers. Participants need proper organ function, no severe allergies to the drugs being tested, and agree to use contraception.Check my eligibility
What is being tested?
The study tests Afuresertib combined with Paclitaxel against ovarian cancer that hasn't responded well to platinum treatments. Afuresertib is an AKT inhibitor which may help control cancer progression when paired with chemotherapy.See study design
What are the potential side effects?
Possible side effects include allergic reactions to drug components, digestive issues due to GI absorption requirements for Afuresertib, blood disorders from hematology parameters criteria, and potential nerve damage as patients with grade >2 neuropathy are excluded.
PROFECTA-II Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My digestive system can absorb medications properly.
Select...
I have ovarian cancer and have had 1-5 chemotherapy treatments, with only one after PROC diagnosis.
Select...
I agree to tests for specific cancer markers and can provide a recent or new tumor sample.
Select...
Side effects from my previous treatments, except for hair loss, are mild or gone.
Select...
My kidney function, measured by creatinine levels, is within the normal range.
Select...
I haven't taken strong CYP3A4/5 inhibitors or inducers for at least 2 weeks.
Select...
I can take care of myself and am up and about more than 50% of my waking hours.
Select...
I have never taken AKT, PI3K, or mTOR inhibitors.
Select...
My ovarian cancer returned 1-6 months after platinum therapy.
Select...
I am a woman over 18 and can sign and follow the consent form.
Select...
My doctor thinks weekly paclitaxel treatment is suitable for me.
Select...
My cancer is a specific type of ovarian cancer, not including low-grade or mucinous types.
Select...
My liver function tests are within the required range.
PROFECTA-II Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline every 6 weeks × 30 weeks, then every 8 weeks through study completion, an average 1 year.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline every 6 weeks × 30 weeks, then every 8 weeks through study completion, an average 1 year.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
PFS based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Secondary outcome measures
Best overall response (BOR) according to RECIST 1.1
CBC
Cancer antigen 125 (CA-125) response (Gynecological Cancer Intergroup [GCIG])
+10 moreOther outcome measures
BOR based on RECIST 1.1
CA-125 response (GCIG)
DCR based on RECIST 1.1 o Alterations of PI3K/AKT/PTEN pathway and BRCA1/2 mutations in tumor samples as assessed by next generation sequencing (NGS) o Levels of phospho AKT in tumor sample as assessed by immunohistochemistry (IHC)
+4 moreSide effects data
From 2014 Phase 4 trial • 32 Patients • NCT0130172959%
Leukopenia
56%
Neutropenia
34%
Hypoaesthesia
31%
Agranulocytosis
22%
Alopecia
22%
Asthenia
19%
Pyrexia
16%
Nail disorder
16%
Oedema peripheral
16%
Diarrhoea
16%
Hypophagia
13%
Neurotoxicity
13%
Alanine aminotransferase increased
13%
Cough
13%
Vomting
9%
Headache
9%
Musculoskeletal pain
9%
Aspartate aminotransferase increased
9%
Chest discomfort
9%
Rash
9%
Pigmentation disorder
9%
Nausea
9%
Bone marrow failure
9%
Anaemia
6%
Transaminases increased
6%
Insomnia
6%
Constipation
6%
Mouth ulceration
6%
Nasopharyngitis
6%
Paronychia
6%
Flushing
6%
Face oedema
6%
Thrombocytopenia
3%
Infection
3%
Upper respiratory tract infection
3%
Completed suicide
3%
Cataract
100%
80%
60%
40%
20%
0%
Study treatment Arm
Trastuzumab
PROFECTA-II Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm 1Experimental Treatment2 Interventions
Arm 1 is afuresertib 125 mg PO QD + paclitaxel 80 mg/m2 intravenous (IV) infusion over 1 hour on Days 1, 8 and 15 of a 3 week cycle.
Group II: Arm 2Active Control1 Intervention
Arm 2 is paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15 of a 3 week cycle
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
2011
Completed Phase 4
~5380
Afuresertib
2014
Completed Phase 1
~30
Find a Location
Who is running the clinical trial?
Laekna LimitedLead Sponsor
5 Previous Clinical Trials
301 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 1
- Group 2: Arm 2
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What therapeutic purposes does Paclitaxel serve?
"Paclitaxel has been used to successfully treat neoplasm metastasis, Kaposi sarcoma, and advanced directives."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger