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 range18 Years

SexALL

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.
✓. 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

What they're measuring

Cohorts 1a/1b: Evaluate safety

Timeframe: Through study completion, up to 12 months.

Cohorts 1a/1b: Evaluate compliance

Timeframe: Through study completion, up to 12 months.

Cohorts 1a/1b: Evaluate the pharmacokinetic impact by measuring Cmax.

Timeframe: Through study completion, up to 12 months.

Cohorts 1a/1b: Evaluate the pharmacokinetic impact by measuring Tmax.

Timeframe: Through study completion, up to 12 months.

Cohorts 1a/1b: Evaluate the pharmacokinetic impact by measuring AUC.

Timeframe: Through study completion, up to 12 months.

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.

Trial details

NCT IDNCT05300048

SponsorFaeth Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-04-30

View on ClinicalTrials.gov More Advanced Solid Tumor trials

Who can participate

Age range18 Years

SexALL

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.
✓. 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

What they're measuring

Cohorts 1a/1b: Evaluate safety

Timeframe: Through study completion, up to 12 months.

Cohorts 1a/1b: Evaluate compliance

Timeframe: Through study completion, up to 12 months.

Cohorts 1a/1b: Evaluate the pharmacokinetic impact by measuring Cmax.

Timeframe: Through study completion, up to 12 months.

Cohorts 1a/1b: Evaluate the pharmacokinetic impact by measuring Tmax.

Timeframe: Through study completion, up to 12 months.

Cohorts 1a/1b: Evaluate the pharmacokinetic impact by measuring AUC.

Timeframe: Through study completion, up to 12 months.

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.