Combination of Serabelisib and Insulin Suppressing Diet With or Without Nab-paclitaxel in Subject… (NCT05300048) | Clinical Trial Compass
TerminatedPhase 1
Combination of Serabelisib and Insulin Suppressing Diet With or Without Nab-paclitaxel in Subjects With Advanced Solid Tumors With PIK3CA Mutations
Stopped: Program prioritization
United States34 participantsStarted 2022-04-22
Plain-language summary
This study will evaluate the feasibility of optimizing the safety and tolerability of serabelisib (an investigational PI3K inhibitor) when combined with an ISD and with or without nab-paclitaxel with a goal of reducing side effects and enhancing anticancer activity.
Who can participate
Age range
18 Years
Sex
ALL
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
. Able to provide written informed consent.
. Age ≥18 at Visit -1 (screening).
. Histologically or cytologically confirmed recurrent solid tumors.
. Cohort 1a: any extracranial solid tumor (may include EC, ovarian clear cell, or ovarian endometrioid carcinoma if subject is not eligible for nab-paclitaxel in Cohort
. Cohort 1b: either recurrent or persistent endometrial adenocarcinoma (EC) with the following histologic epithelial cell types: endometrioid adenocarcinoma, serous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, adenocarcinoma not otherwise specified (N.O.S.), mucinous adenocarcinoma, squamous cell carcinoma, transitional cell carcinoma, and carcinosarcoma or; ovarian cancer (OC) with the primary tumor having ≥ 50% clear cell histomorphology or ovarian clear cell or ovarian endometrioid carcinoma.
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
1
Cohorts 1a/1b: Evaluate safety
Timeframe: Through study completion, up to 12 months.
2
Cohorts 1a/1b: Evaluate compliance
Timeframe: Through study completion, up to 12 months.
3
Cohorts 1a/1b: Evaluate the pharmacokinetic impact by measuring Cmax.
Timeframe: Through study completion, up to 12 months.
4
Cohorts 1a/1b: Evaluate the pharmacokinetic impact by measuring Tmax.
Timeframe: Through study completion, up to 12 months.
5
Cohorts 1a/1b: Evaluate the pharmacokinetic impact by measuring AUC.
Timeframe: Through study completion, up to 12 months.
6
Cohorts 2, 3, 4: Use the Objective Response Rate (ORR) to assess the antitumor efficacy of serabelisib in combination with a Study ISD.
Timeframe: Through study completion, an average of 8 months.
. Cohort 2: adenocarcinoma of the colon or rectum.
. Cohort 3: recurrent or persistent endometrial adenocarcinoma with the following histologic epithelial cell types as described for Cohort 1b
. Cohort 4: OC primary tumor carcinomas as described for Cohort 1b
Exclusion criteria
. Diagnosis of primary malignant brain tumor.
. Has had serabelisib, alpelisib, or other PI3K inhibitor.
. Leptomeningeal disease and symptomatic or untreated brain metastases.
. Diagnosis of, or requiring treatment for, another malignancy within the past 2 years (excluding a history of carcinoma in situ of the cervix, superficial non-melanoma skin cancer, or superficial bladder cancer that has been adequately treated, or stage 1 prostate cancer that does not require treatment or requires only treatment with luteinizing hormone-releasing hormone agonists or antagonists if initiated at least 90 days prior to the first dose of Study Drug).
. Is less than 21 days from therapeutic radiation or chemotherapy prior to the first day of dosing with Study Drug and has not recovered to Grade ≤ 1 from all clinically significant toxicities related to prior therapies.
. For subjects receiving nitrosoureas or mitomycin C, the subject is \< 6 weeks from last dose. For monoclonal antibody therapy, the subject is \< 1 half-life or \<4 weeks from the last dose.
. Chronic, systemically administered glucocorticoids in doses equivalent to \>5 mg prednisone daily. Replacement corticosteroids for adrenal insufficiency are permitted.
. Diabetes mellitus requiring insulin or insulin secretagogue therapy.