SarcomaPhase 2NCT04906876
A Phase 2 Study of 9-ING-41Combined With Chemotherapy in Adolescents and Adults With Advanced Sarcomas
A Phase 2 study testing Gemcitabine, Docetaxel and 9-ING-41 in people with Sarcoma and Soft Tissue Sarcoma, run by Brown University at 2 sites in United States.
Trial summary
9-ING-41 in combination with gemcitabine and docetaxel will lead to sustained disease control and/or increase the rates of objective response in patients with unresectable or metastatic soft tissue and bone sarcomas. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Sarcoma, Soft Tissue Sarcoma, Metastatic Sarcoma
- What is being tested?
- Gemcitabine, Docetaxel and 9-ING-41
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2021to Jul 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Stratum A: Patients must have histologically confirmed grade 2 or 3 soft tissue sarcoma that is locally advanced and unresectable, or metastatic, consisting of one of the following subtypes: undifferentiated pleomorphic sarcoma (malignant fibrous histiocytoma), myxofibrosarcoma, leiomyosarcoma, liposarcoma (excluding well-differentiated), angiosarcoma, synovial sarcoma, rhabdomyosarcoma, spindle cell sarcoma and high-grade sarcoma NOS.
- Stratum B: Patients must have histologically confirmed bone sarcoma that is relapsed or refractory following front-line therapy consisting of one of the following subtypes: osteosarcoma and Ewing sarcoma.
- Patients must have at least one site of measurable disease by RECIST 1.1. See Section 12 (Measurement of Effect) for the evaluation of measurable disease.
- Stratum A: No more than three prior lines of systemic therapy. Of note, anthracycline-based chemotherapy is generally considered first-line therapy. Previously untreated patients may be enrolled at the discretion of the treating investigator.
- Stratum B: At least one prior line of systemic therapy.
- Age ≥10 years.
Show all 30Show fewer
- Lansky score ≥50 for patients <16 years or ECOG performance status ≤2 for patients ≥16 years (Karnofsky ≥50%, see Appendix A).
- Life expectancy of greater than 12 weeks.
- Patients must have adequate organ and marrow function as defined below:
- Hemoglobin ≥8 g/dl
- absolute neutrophil count ≥1,000/mcL
- platelets ≥100,000/mcL (transfusion independent)
- total bilirubin ≤1.5x institutional upper limit of normal (ULN) (<3.0 mg/dL and direct bilirubin <1.5 mg/dL if documented Gilbert's syndrome)
- AST(SGOT)/ALT(SGPT) ≤3x institutional ULN (≤ 5 x ULN if liver metastases present)
- creatinine ≤1.5x institutional ULN OR
- glomerular filtration rate (GFR) ≥50 mL/min/1.73 m2
- PT/INR ≤1.5x institutional ULN
- Amylase and lipase ≤1.5x institutional ULN
- Washout period prior to Cycle 1, Day 1:
- ≥ 21 days since last dose of chemotherapy, immunotherapy, or therapeutic radiation treatment.
- ≥ 28 days since last tyrosine kinase inhibitor (or 5 half-lives, whichever is shorter).
- ≥ 7 days since last focal palliative radiation treatment.
- ≥ 28 days since major surgical procedure.
- Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
- For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
- Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
- Women of child-bearing potential must have a negative serum or urine pregnancy test at registration and within 7 days of first study therapy.
- The effects of 9-ING-41 on the developing human fetus are unknown. For this reason and because other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Women may not be breastfeeding during study participation. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 90 days after completion of 9-ING-41 administration.
- Patients must agree to provide tumor tissue, either fresh or archival specimen of primary tumor and/or metastatic lesion. If tumor tissue is not available, then discuss with principal investigator.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Patients with sarcoma histologies other than those listed above will be excluded.
- Prior treatment with 9-ING-41, gemcitabine, or docetaxel.
- Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities > Grade 1) with the exception of alopecia.
- Patients who are receiving any other investigational agents for treatment of their sarcoma.
- Patients who are pregnant or lactating.
- Patients with untreated brain or meningeal metastases. Subjects with history of metastases are eligible provided they do not require ongoing steroid treatment and have shown clinical and radiographic stability for at least 14 days after definitive therapy.
Show all 10Show fewer
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to 9-ING-41, gemcitabine, docetaxel, or other agents used in study.
- Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Has had a previous (within 2 years) or has a current malignancy other than the target cancer with the exception of curatively treated local tumors including carcinoma in situ of the breast or cervix, basal or squamous cell carcinoma of the skin, or prostate cancer with Gleason Grade < 6 and prostate-specific antigen within normal range.
- Has any medical and/or social condition that, in the opinion of the investigator would preclude study participation.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Hasbro Children's Hospital
Providence, Rhode Island, 02903
Lifespan Cancer Insitute
Providence, Rhode Island, 02903
About this study
Official title: A Phase 2 Study of 9-ING-41, a Glycogen Synthase Kinase-3 Beta (GSK-3β) Inhibitor, Combined With Chemotherapy in Adolescents and Adults With Advanced Sarcomas
9-ING-41 in combination with gemcitabine and docetaxel will lead to sustained disease control and/or increase the rates of objective response in patients with unresectable or metastatic soft tissue and bone sarcomas.
This is an open label, two-stratum, phase 2 clinical trial evaluating the efficacy of 9-ING-41 in combination with gemcitabine/docetaxel in patients ≥10 years of age with advanced sarcoma.
Read more
Stratum A: Patients with advanced soft tissue sarcoma previously treated with 0-3 prior lines of systemic therapy will receive 9-ING-41 twice weekly with gemcitabine on days 1 and 8 and docetaxel on day 8 of a 21-day cycle until disease progression or unacceptable toxicity.
Stratum B: Patients with relapsed or refractory bone sarcoma previously treated with at least one line of systemic therapy will receive 9-ING-41 twice weekly with gemcitabine on days 1 and 8 and docetaxel on day 8 of a 21-day cycle until disease progression or unacceptable toxicity.
Disease response assessment will be performed every 2 cycles (6 weeks) for the first 8 cycles (24 weeks), then every 12 weeks thereafter.
- Conditions
- Sarcoma, Soft Tissue Sarcoma, Metastatic Sarcoma, Undifferentiated Pleomorphic Sarcoma, Myxofibrosarcoma, Leiomyosarcoma
- Being tested
- Gemcitabine, Docetaxel, 9-ING-41
- Medical subject headings
- Sarcoma, Histiocytoma, Malignant Fibrous, Dermatofibrosarcoma, Leiomyosarcoma, Liposarcoma, Hemangiosarcoma, Sarcoma, Synovial, Rhabdomyosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemcitabineDrug
Gemcitabine as a 90-minute IV infusion
DocetaxelDrug
Docetaxel as a 60-minute IV infusion
9-ING-41Drug
9-ING-41 as an IV infusion over 1-4 hours twice weekly
| Study group | Role | What they receive |
|---|---|---|
| Stratum A: Soft Tissue Sarcoma | Experimental | Patients with advanced soft tissue sarcoma previously treated with 0-3 prior lines of systemic therapy will receive 15 mg/kg 9-ING-41 twice weekly with 900 mg/m2 gemcitabine on days 1 and 8 and 75 mg/m2 docetaxel on day 8 of a 21-day cycle until disease progression or unacceptable toxicity. Receives: Drug: Gemcitabine; Drug: Docetaxel; Drug: 9-ING-41 |
| Stratum B: Bone Sarcoma | Experimental | Patients with relapsed or refractory bone sarcoma previously treated with at least one line of systemic therapy will receive 15 mg/kg 9-ING-41 twice weekly with 900 mg/m2 gemcitabine on days 1 and 8 and 75 mg/m2 docetaxel on day 8 of a 21-day cycle until disease progression or unacceptable toxicity. Receives: Drug: Gemcitabine; Drug: Docetaxel; Drug: 9-ING-41 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Control Rate
To determine the Disease Control Rate (DCR = Complete Response [CR] + Partial Response [PR] + Stable Disease [SD] at 6 months) of 9-ING-41 in combination with gemcitabine and docetaxel in advanced sarcoma.
Measured: Approximately 24 weeks
Secondary outcomes (1)
Progression Free Survival
To determine the activity of 9-ING-41 with chemotherapy by assessing progression free survival (PFS).
Measured: From start of protocol therapy, approximately 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2021
- Study startSep 2021 (estimated)
- Primary completionJul 2022 (estimated)
- Study completionJul 2025 (estimated)
Why it stopped: IND withdrawn
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcomaStudies of the same condition, open and under way.
- More trials run by Brown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- Actuate Therapeutics Inc.
- Responsible party
- Sponsor
- Investigators
- Bradley DeNardo, MD, Principal investigator, Brown UniversityDon S Dizon, MD, Principal investigator, Lifespan Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04906876
- Sponsor's protocol ID
- BrUOG 398
- Status last verified
- Jul 2021
- First submitted
- 21 May 2021
- Last updated
- 28 Jul 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of 9-ING-41, a Glycogen Synthase Kinase-3 Beta (GSK-3β) Inhibitor, Combined With Chemotherapy in Adolescents and Adults With Advanced Sarcomas
- ClinicalTrials.gov ID
- NCT04906876
- Acronym / sponsor ID
- BrUOG 398
- Conditions
- Sarcoma, Soft Tissue Sarcoma, Metastatic Sarcoma, Undifferentiated Pleomorphic Sarcoma, Myxofibrosarcoma, Leiomyosarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: IND withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- Actuate Therapeutics Inc.
- Study start
- Sep 2021 (estimated)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 28 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
9-ING-41 in combination with gemcitabine and docetaxel will lead to sustained disease control and/or increase the rates of objective response in patients with unresectable or metastatic soft tissue and bone sarcomas.
This is an open label, two-stratum, phase 2 clinical trial evaluating the efficacy of 9-ING-41 in combination with gemcitabine/docetaxel in patients ≥10 years of age with advanced sarcoma.
Stratum A: Patients with advanced soft tissue sarcoma previously treated with 0-3 prior lines of systemic therapy will receive 9-ING-41 twice weekly with gemcitabine on days 1 and 8 and docetaxel on day 8 of a 21-day cycle until disease progression or unacceptable toxicity.
Stratum B: Patients with relapsed or refractory bone sarcoma previously treated with at least one line of systemic therapy will receive 9-ING-41 twice weekly with gemcitabine on days 1 and 8 and docetaxel on day 8 of a 21-day cycle until disease progression or unacceptable toxicity.
Disease response assessment will be performed every 2 cycles (6 weeks) for the first 8 cycles (24 weeks), then every 12 weeks thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stratum A: Soft Tissue Sarcoma | Experimental | Drug: Gemcitabine, Drug: Docetaxel, Drug: 9-ING-41Patients with advanced soft tissue sarcoma previously treated with 0-3 prior lines of systemic therapy will receive 15 mg/kg 9-ING-41 twice weekly with 900 mg/m2 gemcitabine on days 1 and 8 and 75 mg/m2 docetaxel on day 8 of a 21-day cycle until disease progression or unacceptable toxicity. |
| Stratum B: Bone Sarcoma | Experimental | Drug: Gemcitabine, Drug: Docetaxel, Drug: 9-ING-41Patients with relapsed or refractory bone sarcoma previously treated with at least one line of systemic therapy will receive 15 mg/kg 9-ING-41 twice weekly with 900 mg/m2 gemcitabine on days 1 and 8 and 75 mg/m2 docetaxel on day 8 of a 21-day cycle until disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (30 listed)
- Stratum A: Patients must have histologically confirmed grade 2 or 3 soft tissue sarcoma that is locally advanced and unresectable, or metastatic, consisting of one of the following subtypes: undifferentiated pleomorphic sarcoma (malignant fibrous histiocytoma), myxofibrosarcoma, leiomyosarcoma, liposarcoma (excluding well-differentiated), angiosarcoma, synovial sarcoma, rhabdomyosarcoma, spindle cell sarcoma and high-grade sarcoma NOS.
- Stratum B: Patients must have histologically confirmed bone sarcoma that is relapsed or refractory following front-line therapy consisting of one of the following subtypes: osteosarcoma and Ewing sarcoma.
- Patients must have at least one site of measurable disease by RECIST 1.1. See Section 12 (Measurement of Effect) for the evaluation of measurable disease.
- Stratum A: No more than three prior lines of systemic therapy. Of note, anthracycline-based chemotherapy is generally considered first-line therapy. Previously untreated patients may be enrolled at the discretion of the treating investigator.
- Stratum B: At least one prior line of systemic therapy.
Key exclusion criteria (10 listed)
- Patients with sarcoma histologies other than those listed above will be excluded.
- Prior treatment with 9-ING-41, gemcitabine, or docetaxel.
- Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities > Grade 1) with the exception of alopecia.
- Patients who are receiving any other investigational agents for treatment of their sarcoma.
- Patients who are pregnant or lactating.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GemcitabineGemcitabine as a 90-minute IV infusion | Drug | Stratum A: Soft Tissue Sarcoma, Stratum B: Bone Sarcoma |
| DocetaxelDocetaxel as a 60-minute IV infusion | Drug | Stratum A: Soft Tissue Sarcoma, Stratum B: Bone Sarcoma |
| 9-ING-419-ING-41 as an IV infusion over 1-4 hours twice weekly | Drug | Stratum A: Soft Tissue Sarcoma, Stratum B: Bone Sarcoma |
Primary outcome
Disease Control Rate
Time frame: Approximately 24 weeks
To determine the Disease Control Rate (DCR = Complete Response [CR] + Partial Response [PR] + Stable Disease [SD] at 6 months) of 9-ING-41 in combination with gemcitabine and docetaxel in advanced sarcoma.
1 secondary outcome
Progression Free Survival
Time frame: From start of protocol therapy, approximately 5 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2021.
Related trials for Sarcoma
RecruitingPhase 2
A Multicenter Phase II Clinical Trial Evaluating 68Ga-HX01 Injection for PET/CT Imaging
Soft Tissue Sarcoma
RecruitingPhase 3
Measuring if Immunotherapy Plus Chemotherapy is Better Than Chemotherapy Alone for Patients With Aggressive Poorly Differentiated Sarcomas
Metastatic Dedifferentiated Liposarcoma, Metastatic Undifferentiated Pleomorphic Sarcoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 1/2
Dose Escalation and Dose Expansion Study of MDX2003 in Patients With Different Types of Lymphoma
Lymphoma, Waldenström Macroglobulinemia (WM)
Enrolling by invitationPhase 1
Evaluation of the I-phase Clinical Trial of 177Lu-HX02 Injection in Patients With Advanced Malignant Solid Tumors
Soft Tissue Sarcoma, Non-small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bradley DeNardo, MD principal investigator
Brown University
Don S Dizon, MD principal investigator
Lifespan Cancer Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gemcitabine, Docetaxel and 9-ING-41 in people with Sarcoma and Soft Tissue Sarcoma, run by Brown University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 30 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease Control Rate (time frame: Approximately 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2021.