← Back to Search

ALK Inhibitor

Targeted Therapy + Immunotherapy for Advanced Cancer

Phase 2
Recruiting
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
For male participants: Willingness to remain abstinent or use acceptable methods of contraception as defined in the cohort-specific inclusion criteria
Disease progression on prior treatment, or previously untreated disease with no available acceptable treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately up to 12 years
Awards & highlights

Study Summary

This trial is designed to study the safety and efficacy of targeted therapies or immunotherapy for people with unresectable, locally advanced or metastatic solid tumors.

Who is the study for?
Adults and children with advanced, inoperable or metastatic solid tumors that have specific genetic changes identified by a special test. They must be physically able to participate (with varying performance scores based on age), have no other treatments available or have progressed after treatment, and not be pregnant or breastfeeding. Participants need to agree to use effective contraception.Check my eligibility
What is being tested?
The TAPISTRY trial is testing how well different targeted therapies or immunotherapies work for patients whose tumors have certain genomic alterations or high mutation burdens. Patients receive personalized treatment based on their tumor's genetic profile, which could include drugs like Ipatasertib, Atezolizumab, etc., alone or combined.See study design
What are the potential side effects?
Potential side effects depend on the specific drugs given but may include fatigue, nausea, diarrhea, skin reactions, liver issues, blood clots and an increased risk of infections. Some treatments might also cause allergic reactions or affect heart function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a man willing to use contraception or remain abstinent as required.
Select...
My cancer has worsened after treatment or I haven't been treated because there are no suitable options.
Select...
My blood and organs are functioning well.
Select...
I am active and can care for myself regardless of my age.
Select...
I am active and can care for myself regardless of my age.
Select...
My cancer is advanced, cannot be surgically removed, and has spread.
Select...
I have recovered from my last cancer treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately up to 12 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately up to 12 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
All Cohorts: Independent Review Committee (IRC)-assessed objective response rate (ORR) based on confirmed objective response (OR) per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Secondary outcome measures
All Cohorts: Change from Baseline in the EORTC-QLQ-C30 total score
All Cohorts: INV-assessed CBR per RECIST v1.1
All Cohorts: INV-assessed CBR per RECIST v1.1 in participants with alteration/biomarker-positive ctDNA by blood-based NGS assay
+54 more

Trial Design

14Treatment groups
Experimental Treatment
Group I: Cohort N: SETD2 Loss of Function tumorsExperimental Treatment1 Intervention
Participants with SETD2 Loss of Function tumors will self-administer Camonsertib orally at home (except on clinic days).
Group II: Cohort M: ATM Loss of Function tumorsExperimental Treatment1 Intervention
Participants with ATM Loss of Function tumors will self-administer Camonsertib orally at home (except on clinic days).
Group III: Cohort L: KRAS G12C-positive tumors (excluding NSCLC and CRC)Experimental Treatment1 Intervention
Participants with KRAS G12C-positive tumors will self-administer GDC-6036 orally at home (except on clinic days).
Group IV: Cohort K: RET fusion-positive tumors (excluding NSCLC)Experimental Treatment1 Intervention
Participants with RET fusion-positive tumors will self-administer Pralsetinib orally at home (except on clinic days) on a continuous daily dosing regimen at a dose of 400 mg/day (four 100-mg capsules per day) for adult and pediatric patients ≥ 12 and < 18 years of age. A treatment cycle consists of 4 weeks (28 days). Note: Cohort K has been closed for enrollment
Group V: Cohort J: BRAF class III mutant-positive tumorsExperimental Treatment1 Intervention
Participants with BRAF class III mutant-positive tumors(adults and adolescents ≥ 40 kg) will receive 400 mg belvarafenib by mouth (PO) BID (twice a day) with adequate water (more than 200 mL). One cycle consists of 28 days. Administration of belvarafenib should occur BID on every day of each 28-day cycle. Note: Cohort J has been closed for enrollment
Group VI: Cohort I: BRAF class II mutant or fusion-positive tumorsExperimental Treatment1 Intervention
Participants with BRAF class II mutant/fusion-positive tumors (adults and adolescents ≥ 40 kg) will receive 400 mg belvarafenib by mouth (PO) BID (twice a day) with adequate water (more than 200 mL). One cycle consists of 28 days. Administration of belvarafenib should occur BID on every day of each 28-day cycle. Note: Cohort I has been closed for enrollment
Group VII: Cohort H: PIK3CA multiple mutant-positive tumorsExperimental Treatment1 Intervention
Participants with metastatic or advanced solid tumors will receive GDC-0077 QD at a starting dose of 9 mg by mouth (PO) in repeated 28-day cycles. Note: Cohort H has been closed for enrollment
Group VIII: Cohort G: MDM2-amplified, TP53 wild-type tumorsExperimental Treatment1 Intervention
Participants with metastatic or advanced solid tumors will receive idasanutlin at a dose of 250 mg orally QD on Days 1-5 of each 28-day cycle. Note: Cohort G has been closed for enrollment
Group IX: Cohort F: HER2 mutant-positive tumorsExperimental Treatment1 Intervention
Participants with metastatic or advanced solid tumors will receive trastuzumab emtansine IV at a dose of 3.6 mg/kg every 21 days. Note: Cohort F has been closed for enrollment
Group X: Cohort E: AKT1/2/3 mutant-positive tumorsExperimental Treatment1 Intervention
Participants with metastatic or advanced solid tumors will receive ipatasertib orally once daily (QD) at the starting dose of 400 mg in repeated 28-day cycles until the participant experiences disease progression, intolerable toxicity, or withdraws consent. For participants 12-17 years of age, ipatasertib will be administered at the starting dose of 200 mg for participants <35 kg, 300 mg for participants >/= 35 and <45 kg, 400 mg for those >/=45 kg orally QD in repeated 28-day cycles until the participant experiences disease progression, intolerable toxicity, or withdraws consent. Note: Cohort E has been closed for enrollment
Group XI: Cohort D: TMB-high tumorsExperimental Treatment1 Intervention
Participants with metastatic or advanced solid tumors will receive atezolizumab intravenously (IV) at a fixed dose for participants aged >/= 18 years, and 15 mg/kg (maximum 1200 mg) for participants aged < 18 years on Day 1 of each 21-day cycle. Note: Cohort D has been closed for enrollment
Group XII: Cohort C: ALK fusion-positive tumors (excluding NSCLC)Experimental Treatment1 Intervention
Participants with metastatic or advanced solid tumors, with the exception of NSCLC, will receive alectinib at a dosage of 600 mg orally twice a day (BID), taken with food, in repeated 28-day cycles.
Group XIII: Cohort B: NTRK1/2/3 fusion-positive tumorsExperimental Treatment1 Intervention
Participants with metastatic or advanced solid tumors will receive entrectinib once daily in repeated 28-day cycles at a dose of 600 mg/day for adults and pediatric participants with a BSA >/= 1.51 m2. The total dose of daily entrectinib administration for pediatric participants with BSA<1.51 m2 will be lower.
Group XIV: Cohort A: ROS1 Fusion-positive tumors (excluding NSCLC)Experimental Treatment1 Intervention
Participants with metastatic or advanced solid tumors, with the exception of NSCLC will receive entrectinib once daily in repeated 28-day cycles at a dose of 600 milligram per day (mg/day) for adults and pediatric participants with a body surface area (BSA) >/= 1.51 squaremeter (m2). The total dose of daily entrectinib administration for pediatric participants with BSA<1.51 m2 will be lower.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ipatasertib
2011
Completed Phase 3
~2320
Idasanutlin
2018
Completed Phase 2
~380
Entrectinib
2014
Completed Phase 2
~360
Atezolizumab
2017
Completed Phase 3
~5860
Inavolisib
2021
Completed Phase 2
~260
Alectinib
2015
Completed Phase 3
~2400
Pralsetinib
2021
Completed Phase 2
~260
Trastuzumab emtansine
2010
Completed Phase 4
~2220

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,428 Previous Clinical Trials
1,088,134 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,199 Previous Clinical Trials
887,582 Total Patients Enrolled

Media Library

Alectinib (ALK Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04589845 — Phase 2
Solid Tumors Research Study Groups: Cohort A: ROS1 Fusion-positive tumors (excluding NSCLC), Cohort B: NTRK1/2/3 fusion-positive tumors, Cohort C: ALK fusion-positive tumors (excluding NSCLC), Cohort D: TMB-high tumors, Cohort E: AKT1/2/3 mutant-positive tumors, Cohort G: MDM2-amplified, TP53 wild-type tumors, Cohort H: PIK3CA multiple mutant-positive tumors, Cohort K: RET fusion-positive tumors (excluding NSCLC), Cohort L: KRAS G12C-positive tumors (excluding NSCLC and CRC), Cohort M: ATM Loss of Function tumors, Cohort N: SETD2 Loss of Function tumors, Cohort J: BRAF class III mutant-positive tumors, Cohort F: HER2 mutant-positive tumors, Cohort I: BRAF class II mutant or fusion-positive tumors
Solid Tumors Clinical Trial 2023: Alectinib Highlights & Side Effects. Trial Name: NCT04589845 — Phase 2
Alectinib (ALK Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04589845 — Phase 2

Frequently Asked Questions

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

In how many different areas is this research being conducted?

"Patients are currently being accepted at the Ocala Oncology Center in Florida, The Icahn School of Medicine at Mount Sinai in New york, and The Hospital for Sick Children based in Toronto. In addition to these 50 sites, there are other recruitment locations."

Answered by AI

What other Ipatasertib studies have been completed and what were the results?

"Ipatasertib was first studied in 2008 by Can Care Assoc Med Group Inc; Beach Cities Offices. So far, there have been 149 completed trials, with 428 live studies currently underway - many of which are being conducted out of Ocala, Florida."

Answered by AI

Are we still looking for volunteers for this experiment?

"From what is available on clinicaltrials.gov, this study appears to be actively recruiting patients at the moment. The listing for this trial was first published on 18th January 2021 with the latest update being from 26th October 2022."

Answered by AI

What are the medical conditions that Ipatasertib is approved to target?

"Ipatasertib is most frequently used as an anticancer medication. However, it can also be employed to treat conditions like therapeutic procedure, disease, and breast cancer (triple negative breast cancer (tnbc))."

Answered by AI

How many participants are in this clinical trial?

"In order to successfully run this experiment,770 patients that fit the bill need to enroll. These individuals can come from locations such as Ocala Oncology Center in Ocala, Florida and Icahn School of Medicine at Mount Sinai in New york, New York."

Answered by AI

When might Ipatasertib be cleared for general use?

"Ipatasertib's safety is supported by some data, giving it a score of 2."

Answered by AI

Is this research project the first of its kind?

"A total of 428 ongoing clinical trials worldwide are using Ipatasertib as an investigational drug. These studies originated from 2101 cities and 77 countries, with the first one taking place in 2008. That trial, which was sponsored by Hoffmann-La Roche, completed its Phase 2 stage and involved 720 patients. To date, 149 similar trials have been run."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What site did they apply to?
Miami Cancer Institute of Baptist Health, Inc.
McGill University Health Center
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I want try drugs for my breast cancer i have her 2 in stage 2, 3 pls help me.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Tumor-Agnostic Precision Immuno-Oncology and Somatic Targeting Rational for You (TAPISTRY) Platform Study
2021. "Tumor-Agnostic Precision Immuno-Oncology and Somatic Targeting Rational for You (TAPISTRY) Platform Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04589845.
~613 spots leftby Sep 2032
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top