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PI3K Inhibitor

Taselisib for Cancer

Phase 2
Waitlist Available
Led By Ian E Krop
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Patients with known left ventricular dysfunction must have echocardiogram (ECHO) or multigated acquisition scan (MUGA) within 4 weeks prior to registration to treatment and must not have left ventricular ejection fraction (LVEF) < institutional lower limit of normal (LLN). If the LLN is not defined at a site, the LVEF must be > 50% for the patient to be eligible
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed at baseline, then every 2 cycles for the first 26 cycles and every 3 cycles thereafter until disease progression, up to 3 years post registration
Awards & highlights

Study Summary

This trial is testing the effects of a drug called taselisib in patients whose cancer has a genetic mutation called PIK3CA. Taselisib may stop the growth of cancer cells by blocking PIK3CA, a protein that may be needed for cell growth.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While not explicitly listed in the provided information, drugs like Taselisib may cause side effects such as high blood sugar levels, diarrhea, skin rash, fatigue and liver function changes based on its mechanism of action and drug class.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been treated with an mTOR inhibitor before.
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My heart's pumping ability is normal according to recent tests.
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My recent ECG showed no significant heart issues.
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My fasting blood sugar level is 125 mg/dL or lower.
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My cancer has a PIK3CA mutation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed at baseline, then every 2 cycles for the first 26 cycles and every 3 cycles thereafter until disease progression, up to 3 years post registration
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed at baseline, then every 2 cycles for the first 26 cycles and every 3 cycles thereafter until disease progression, up to 3 years post registration for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Response Rate (ORR)
Secondary outcome measures
6-Month Progression-free Survival (PFS) Rate
Progression-free Survival (PFS)

Side effects data

From 2017 Phase 2 trial • 334 Patients • NCT02273973
29%
Diarrhoea
21%
Nausea
20%
Fatigue
16%
Hyperglycaemia
15%
Hot flush
13%
Stomatitis
11%
Arthralgia
10%
Asthenia
10%
Headache
9%
Rash
8%
Alopecia
7%
Decreased appetite
6%
Dry skin
6%
Constipation
6%
Vomiting
6%
Hypertension
5%
Alanine aminotransferase increased
5%
Dizziness
5%
Cough
5%
Dyspepsia
4%
Dry mouth
4%
Viral upper respiratory tract infection
4%
Urinary tract infection
4%
Back pain
4%
Insomnia
4%
Pruritus
1%
Erysipelas
1%
Enterocolitis haemorrhagic
1%
Sudden death
1%
Erythema multiforme
1%
Dehydration
1%
Pneumonitis
1%
Bacterial diarrhoea
1%
Cytomegalovirus infection
1%
Diarrhoea infectious
1%
Gastroenteritis
1%
Pneumonia
1%
Colitis
1%
Enterocolitis
1%
Impaired healing
1%
Postoperative wound infection
1%
Memory impairment
100%
80%
60%
40%
20%
0%
Study treatment Arm
Experimental: Taselisib + Letrozole
Placebo Comparator: Placebo + Letrozole

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (taselisib)Experimental Treatment1 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Taselisib
2014
Completed Phase 2
~2230

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,933,083 Total Patients Enrolled
Ian E KropPrincipal InvestigatorECOG-ACRIN Cancer Research Group

Media Library

Taselisib (PI3K Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04439175 — Phase 2
Cancer Research Study Groups: Treatment (taselisib)
Cancer Clinical Trial 2023: Taselisib Highlights & Side Effects. Trial Name: NCT04439175 — Phase 2
Taselisib (PI3K Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04439175 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent is the participant pool of this clinical trial expanding?

"This trial is not currently enrolling, as the last update was on February 4th 2022. However, there are presently 2 studies involving Taselisib and 4663 trials that focus on neoplasms or plasma cell actively recruiting patients if you look for other medical options."

Answered by AI

Are there any precedents to Taselisib's current clinical trial?

"Presently, two clinical trials studying Taselisib are active. However none of these have yet to reach Phase 3 status. Most studies for this treatment center around Berkeley in California but there is a total of 1458 sites running tests for it."

Answered by AI

Has the FDA sanctioned Taselisib for use?

"The safety of Taselisib has been evaluated and rated a 2 on the scale due to Phase 2 trials having only some evidence backing its security, but not efficacy."

Answered by AI

Are there still opportunities to join this research initiative?

"Unfortunately, recruitment for this trial has been suspended. It was initially posted on February 25th 2016 and its last edit happened on February 4th 2022. On the other hand, there are currently 4663 studies that accept participants with neoplasms or plasma cell issues; additionally, 2 trials involving Taselisib have open enrolment periods as well."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Testing GDC-0032 (Taselisib) as a Potential Targeted Treatment in Cancers With PIK3CA Genetic Changes (MATCH-Subprotocol I)
2016. "Testing GDC-0032 (Taselisib) as a Potential Targeted Treatment in Cancers With PIK3CA Genetic Changes (MATCH-Subprotocol I)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04439175.
~8 spots leftby Apr 2025
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