Testing GDC-0032 (Taselisib) as a Potential Targeted Treatment in Cancers With PIK3CA Genetic Changes (MATCH-Subprotocol I)

Last updated: May 5, 2026
Sponsor: National Cancer Institute (NCI)
Overall Status: Active - Not Recruiting

Phase

2

Condition

Cancer

Bone Neoplasm

Multiple Myeloma

Treatment

Taselisib

Clinical Study ID

NCT04439175
NCI-2020-03142
EAY131-I
U10CA180820
U24CA196172
NCI-2020-03142
  • Ages > 18
  • All Genders

Study Summary

This phase II MATCH treatment trial identifies the effects of GDC-0032 (taselisib) in patients whose cancer has a genetic change called PIK3CA mutation. Taselisib may stop the growth of cancer cells by blocking PIK3CA, a protein that may be needed for cell growth. Researchers hope to learn if taselisib will shrink this type of cancer or stop its growth.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients must have met applicable eligibility criteria in the Master MATCH Protocolprior to registration to treatment subprotocol

  • Patients must have a PIK3CA mutation as determined via the MATCH Master Protocol

  • Patients must have an electrocardiogram (ECG) within 8 weeks prior to treatmentassignment and must have no clinically important abnormalities in rhythm, conductionor morphology of resting ECG (e.g. complete left bundle branch block, third degreeheart block)

  • Patients with known left ventricular dysfunction must have echocardiogram (ECHO) ormultigated acquisition scan (MUGA) within 4 weeks prior to registration to treatmentand must not have left ventricular ejection fraction (LVEF) < institutional lowerlimit of normal (LLN). If the LLN is not defined at a site, the LVEF must be > 50%for the patient to be eligible

  • Patients must have a fasting glucose =< 125 mg/dL

  • NOTE: Please provide clear documentation that the glucose test was conducted ata fasting state

  • Patients with prior treatment with an mTOR inhibitor are acceptable. These include,but are not limited to: temsirolimus, everolimus, ridaforolimus, sirolimus, CC-223,MLN128 (INK128), DS-3078, CC-115, AZD-2014, AZD8055

Exclusion

Exclusion Criteria:

  • Patients must not have known hypersensitivity to GDC-0032 (taselisib) or compoundsof similar chemical or biologic composition

  • Patients must not have breast cancer

  • Patients with squamous cell carcinoma of the lung who have PIK3CA mutations who haveaccess to AND are eligible for Lung-MAP (S1400) are not eligible

  • Patients must not have KRAS mutations, and/or PTEN mutation or loss, detected in thetumor sample as determined by the MATCH screening assessment. PTEN loss will bedetermined by immunohistochemistry

  • Patients must not have had prior therapy with a PI3K inhibitor or PI3K/mTORinhibitor. These include, but are not limited to: BEZ235, XL-765 (SAR245409),GDC-0980, PF-04691502, PF-05212384 (PKI-587), SF-1126, GSK 2126458, P-7170, BGT-226,LY3023414, GDC-0084, DS-7423, BKM-120 (buparlisib), PX-866, XL-147, GDC-0941 (pictilisib), VS-5584, BAY-80-6946, ZSTK-474, WX 037, AZD8835, GSK2636771, GS-9820,BYL719, MLN1117 (INK1117), idelalisib, TGR1202, RP6530, duvelisib (IPI-145),CUDC-907. Prior GDC-0032 (taselisib) is not allowed

  • Patients must not have had prior therapy with an Akt inhibitor. These include, butare not limited to: MK-2206, GSK690693, AZD5363, triciribine, perifosine,GSK2141795, GSK2110183, SR13668, BAY1125976, GDC-0068 (ipatasertib), LY2780301,ARQ092

  • Patients must not have type 1 or 2 diabetes requiring anti-hyperglycemic medication (e.g. metformin, glipizide, insulin)

  • Patients must not have current dyspnea at rest or require any daily supplementaloxygen

  • Patients must not have history of inflammatory bowel disease (e.g. Crohn's diseaseor ulcerative colitis) or active bowel inflammation (e.g. diverticulitis)

Study Design

Total Participants: 70
Treatment Group(s): 1
Primary Treatment: Taselisib
Phase: 2
Study Start date:
February 25, 2016
Estimated Completion Date:
March 31, 2027

Study Description

PRIMARY OBJECTIVE:

I. To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas/multiple myeloma.

SECONDARY OBJECTIVES:

I. To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas/multiple myeloma.

II. To evaluate time until death or disease progression. III. To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, ribonucleic acid (RNA), protein and imaging-based assessment platforms.

IV. To assess whether radiomic phenotypes obtained from pre-treatment imaging and changes from pre- through post-therapy imaging can predict objective response and progression free survival and to evaluate the association between pre-treatment radiomic phenotypes and targeted gene mutation patterns of tumor biopsy specimens.

OUTLINE:

Patients receive taselisib orally (PO) once daily (QD) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months if less than 2 years from study entry, and then every 6 months for year 3 from study entry.

Connect with a study center

  • ECOG-ACRIN Cancer Research Group

    Philadelphia, Pennsylvania 19103
    United States

    Site Not Available

  • ECOG-ACRIN Cancer Research Group

    Philadelphia 4560349, Pennsylvania 6254927 19103
    United States

    Site Not Available

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