Taselisib for Cancer

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: National Cancer Institute (NCI)

Must not be taking: PI3K inhibitors, Akt inhibitors

Disqualifiers: Breast cancer, KRAS mutations, diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: Up to 3 years

70 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you have diabetes that requires medication, you may not be eligible to participate.

How is the drug Taselisib unique in treating cancer?

Taselisib is unique because it is a potent and selective inhibitor of the PI3K pathway, specifically targeting PIK3CA-mutant tumors, which makes it potentially more effective for certain types of cancer, like hormone receptor-positive advanced breast cancer. It is taken orally and has shown promising results in combination with other therapies, such as fulvestrant, in clinical trials. ^{1 2 3 4 5}

What is the purpose of this trial?

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.

Research Team

Ian E Krop

Principal Investigator

ECOG-ACRIN Cancer Research Group

Eligibility Criteria

This trial is for patients with various cancers, including blood and solid tumors, who have a specific genetic change (PIK3CA mutation). They must not have diabetes requiring medication, no history of inflammatory bowel disease or certain heart conditions. Prior treatment with mTOR inhibitors is okay but no prior therapy with PI3K/mTOR or Akt inhibitors.

Inclusion Criteria

I have been treated with an mTOR inhibitor before.

My fasting blood sugar level is 125 mg/dL or lower.

My heart's pumping ability is normal according to recent tests.

Exclusion Criteria

My cancer does not have KRAS or PTEN mutations.

I do not have squamous cell lung cancer with PIK3CA mutations eligible for Lung-MAP.

I do not have a history of inflammatory bowel diseases like Crohn's or ulcerative colitis.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive taselisib orally once daily on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Up to 3 years

Every 2 cycles for the first 26 cycles, then every 3 cycles thereafter

Follow-up

Participants are monitored for safety and effectiveness after treatment completion. Follow-up occurs every 3 months if less than 2 years from study entry, and then every 6 months for year 3.

Up to 3 years

Treatment Details

Interventions

• Taselisib

Trial Overview Researchers are testing Taselisib's effectiveness on cancers with the PIK3CA mutation. This phase II trial aims to see if Taselisib can shrink these cancers or halt their growth by blocking a protein essential for cancer cell development.

Participant Groups

Group I: Treatment (taselisib) Experimental Treatment 1 Intervention

Patients receive taselisib 4 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Findings from Research

In the phase III SANDPIPER study involving 516 postmenopausal women with PIK3CA-mutant breast cancer, taselisib combined with fulvestrant significantly improved progression-free survival (7.4 months) compared to placebo plus fulvestrant (5.4 months), indicating its efficacy in this patient population.

Despite the efficacy in extending progression-free survival, the taselisib combination had a concerning safety profile, with higher rates of serious adverse events (32.0% vs. 8.9% in placebo) and more treatment discontinuations (16.8% vs. 2.3% in placebo), suggesting limited clinical utility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase III randomized study of taselisib or placebo with fulvestrant in estrogen receptor-positive, PIK3CA-mutant, HER2-negative, advanced breast cancer: the SANDPIPER trial. Dent, S., Cortés, J., Im, YH., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Phase I study of taselisib in Japanese patients with advanced solid tumors or hormone receptor-positive advanced breast cancer. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

POSEIDON Trial Phase 1b Results: Safety, Efficacy and Circulating Tumor DNA Response of the Beta Isoform-Sparing PI3K Inhibitor Taselisib (GDC-0032) Combined with Tamoxifen in Hormone Receptor Positive Metastatic Breast Cancer Patients. [2020]

3. Netherlands pubmed.ncbi.nlm.nih.gov

A phase Ib, open-label, dose-escalation study of the safety and pharmacology of taselisib (GDC-0032) in combination with either docetaxel or paclitaxel in patients with HER2-negative, locally advanced, or metastatic breast cancer. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Phase III randomized study of taselisib or placebo with fulvestrant in estrogen receptor-positive, PIK3CA-mutant, HER2-negative, advanced breast cancer: the SANDPIPER trial. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Phase I Dose-Escalation Study of Taselisib, an Oral PI3K Inhibitor, in Patients with Advanced Solid Tumors. [2022]