ONC201 for Refractory Acute Lymphoblastic Leukemia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Refractory Acute Lymphoblastic Leukemia+5 MoreONC201 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new cancer drug to see if it works well and what the side effects are.

Eligible Conditions
  • Refractory Acute Lymphoblastic Leukemia
  • Acute Lymphoblastic Leukemia (ALL)
  • Myelodysplastic Syndrome
  • Acute Recurrent Myeloid Leukemia
  • Refractory Acute Myelogenous Leukemia
  • Refractory Myelodysplastic Syndromes

Treatment Effectiveness

Study Objectives

2 Primary · 1 Secondary · Reporting Duration: 63 days

21 days
Maximum Tolerated Dose (MTD) of ONOC201 in Relapsed or Refractory Acute Myelogenous Leukemia (AML), Myelodysplastic Syndrome (MDS) or Acute Lymphoblastic Leukemia (ALL)
63 days
Objective Response (OR)
Objective Response (OR) (Phase II)

Trial Safety

Side Effects for

Cohort 3-Endometrial Cancer (Female Only)
60%Fatigue
40%Lymphocyte count decreased
40%Dizziness
40%Alkaline phosphatase increased
40%Aspartate aminotransferase increased
30%Diarrhea
30%Alanine aminotransferase increased
20%Hypophosphatemia
20%Abdominal pain
20%Nausea
20%Anemia
20%Dyspnea
10%Vaginal hemorrhage
10%Gastroesophageal reflux disease
10%Malaise
10%Lymphedema
10%Pleural effusion
10%Rhinorrhea
10%Vaginal discharge
10%Mucosal infection
10%Rash maculo-papular
10%Proteinuria
10%Vascular access complication
10%Weight loss
10%Cardiac arrest
10%Atrial flutter
10%Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, Death
10%Dehydration
10%Paresthesia
10%Sinus tachycardia
10%Anorexia
10%Sepsis
10%Creatinine increased
10%Flu like symptoms
10%Edema limbs
10%Back pain
10%Headache
10%Arthralgia
10%Urinary tract infection
10%Myalgia
10%Stroke
10%Thromboembolic event
10%Pain
10%Constipation
10%Cough
10%Lethargy
This histogram enumerates side effects from a completed 2021 Phase 2 trial (NCT03394027) in the Cohort 3-Endometrial Cancer (Female Only) ARM group. Side effects include: Fatigue with 60%, Lymphocyte count decreased with 40%, Dizziness with 40%, Alkaline phosphatase increased with 40%, Aspartate aminotransferase increased with 40%.

Trial Design

10 Treatment Groups

Arm A (Akt/ERK inhibitor ONC201)
1 of 10
Arm C (Akt/ERK inhibitor ONC201)
1 of 10
Arm E (Akt/ERK inhibitor ONC201)
1 of 10
Arm B (Akt/ERK inhibitor ONC201)
1 of 10
Arm D (Akt/ERK inhibitor ONC201)
1 of 10
Arm A: ONC201 Once Every 3 Weeks
1 of 10
Arm B: ONC201 Once Every 1 Week
1 of 10
Arm C: ONC201 On First Two Consecutive Days of Every Week
1 of 10
Arm D: ONC201 Once Daily
1 of 10
Arm E: ONC201 Once Daily + Cytarabine
1 of 10

Experimental Treatment

120 Total Participants · 10 Treatment Groups

Primary Treatment: ONC201 · No Placebo Group · Phase 1 & 2

Arm A (Akt/ERK inhibitor ONC201)
Drug
Experimental Group · 1 Intervention: Akt/ERK Inhibitor ONC201 · Intervention Types: Drug
Arm C (Akt/ERK inhibitor ONC201)
Drug
Experimental Group · 1 Intervention: Akt/ERK Inhibitor ONC201 · Intervention Types: Drug
Arm E (Akt/ERK inhibitor ONC201)
Drug
Experimental Group · 1 Intervention: Akt/ERK Inhibitor ONC201 · Intervention Types: Drug
Arm B (Akt/ERK inhibitor ONC201)
Drug
Experimental Group · 1 Intervention: Akt/ERK Inhibitor ONC201 · Intervention Types: Drug
Arm D (Akt/ERK inhibitor ONC201)
Drug
Experimental Group · 1 Intervention: Akt/ERK Inhibitor ONC201 · Intervention Types: Drug
Arm A: ONC201 Once Every 3 Weeks
Drug
Experimental Group · 1 Intervention: ONC201 · Intervention Types: Drug
Arm B: ONC201 Once Every 1 Week
Drug
Experimental Group · 1 Intervention: ONC201 · Intervention Types: Drug
Arm C: ONC201 On First Two Consecutive Days of Every Week
Drug
Experimental Group · 1 Intervention: ONC201 · Intervention Types: Drug
Arm D: ONC201 Once Daily
Drug
Experimental Group · 1 Intervention: ONC201 · Intervention Types: Drug
Arm E: ONC201 Once Daily + CytarabineExperimental Group · 2 Interventions: ONC201, Cytarabine · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ONC-201
Not yet FDA approved
Cytarabine
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 63 days

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,805 Previous Clinical Trials
1,790,259 Total Patients Enrolled
Oncoceutics, Inc.Industry Sponsor
5 Previous Clinical Trials
133 Total Patients Enrolled
Gautam Borthakur, MBBSPrincipal InvestigatorM.D. Anderson Cancer Center
7 Previous Clinical Trials
136 Total Patients Enrolled
Gautam BorthakurPrincipal InvestigatorM.D. Anderson Cancer Center
4 Previous Clinical Trials
244 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Total bilirubin =< 1.5 x the ULN.
You have no active GVHD.
You have a performance status of 0-2.
You have a serum creatinine level of < 2.0 mg/dl.