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AKT Inhibitor

Afuresertib + 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
- Toxicities of prior therapy (except alopecia) should have been resolved to less than or equal to grade 1 as per NCI-CTCAE v5.0.
- Creatinine within 1.5 × ULN or creatinine clearance > 30 mL/min by Cockcroft Gault formula (Appendix 1).
Must not have
Any medical contraindication to the use of paclitaxel.
Presence of other active cancer within 3 years prior to enrollment (other than basal cell or squamous cell skin cancer, or any other cancer in situ currently in complete remission).
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 of 1 year
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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Side effects from my previous treatments, except for hair loss, are mild or gone.
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My kidney function, measured by creatinine levels, is within the normal range.
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 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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have no health issues that prevent me from taking paclitaxel.
Select...
I have not had any active cancer except for skin cancer or in situ cancer in remission in the last 3 years.
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I am not on strong HIV medication.
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I do not have active hepatitis B or C.
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I have a history of serious heart rhythm problems.
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I have a condition that could lead to seizures or have brain-related issues needing medication.
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I have or might have cancer spread to my brain.
Select...
I have fluid buildup in my abdomen that isn't responding to treatment.
Select...
I have severe nerve pain or damage.

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 of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline every 6 weeks × 30 weeks, then every 8 weeks through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
PFS based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Secondary study objectives
CBC
Clinical Chemistry
Electrocardiogram (ECG)
+4 more

Side effects data

From 2014 Phase 4 trial • 32 Patients • NCT01301729
59%
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%
Musculoskeletal pain
9%
Aspartate aminotransferase increased
9%
Headache
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
~5370
Afuresertib
2020
Completed Phase 2
~180

Find a Location

Who is running the clinical trial?

Laekna LimitedLead Sponsor
7 Previous Clinical Trials
459 Total Patients Enrolled

Media Library

Afuresertib (AKT Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04374630 — Phase 2
Ovarian Cancer Research Study Groups: Arm 1, Arm 2
Ovarian Cancer Clinical Trial 2023: Afuresertib Highlights & Side Effects. Trial Name: NCT04374630 — Phase 2
Afuresertib (AKT Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04374630 — Phase 2
~28 spots leftby Nov 2025
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