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Alkylating agents

TH-302 Dose escalation for Gastrointestinal Stromal Tumors (TH-CR-410 Trial)

Phase 1
Waitlist Available
Led By Mohammed Milhem, MD
Research Sponsored by Threshold Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up two years
Awards & highlights

TH-CR-410 Trial Summary

The primary objectives are: Dose escalation: 1. To determine the MTD and DLT(s) of TH-302 when used in combination with sunitinib. Dose expansion: To make a preliminary assessment of the efficacy of TH-302 in combination with sunitinib as determined by the response rate and the progression-free survival in subjects with advanced RCC treated at the RP2D To assess the safety of TH-302 in combination with sunitinib and determine a recommended Phase 2 dose of the combination. The secondary objectives are: Dose expansion: 1. To make a preliminary assessment of the efficacy of TH-302 in combination with sunitinib as determined by stable disease or better rate, duration of response and overall survival in subjects with advanced RCC treated at the RP2D. The exploratory objective is: 1. To explore the association of serum hypoxia biomarkers with efficacy endpoints.

Eligible Conditions
  • Gastrointestinal Stromal Tumors
  • Kidney Cancer
  • Pancreatic Neuroendocrine Tumors

TH-CR-410 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~two years
This trial's timeline: 3 weeks for screening, Varies for treatment, and two 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
To determine the MTD and DLT(s) of TH-302 when used in combination with sunitinib.
Secondary outcome measures
To make a preliminary assessment of the efficacy of TH-302 in combination with sunitinib as determined by the response rate and the progression-free survival in subjects with advanced RCC treated at the RP2D.

Side effects data

From 2016 Phase 3 trial • 693 Patients • NCT01746979
44%
Nausea
34%
Decreased appetite
32%
Vomiting
32%
Anaemia
31%
Fatigue
30%
Constipation
28%
Neutropenia
26%
Diarrhoea
22%
Pyrexia
21%
Abdominal pain
21%
Oedema peripheral
21%
Asthenia
18%
Thrombocytopenia
16%
Stomatitis
13%
Rash
13%
Platelet count decreased
13%
Back pain
11%
Abdominal pain upper
10%
Dysgeusia
9%
Neutrophil count decreased
9%
Leukopenia
8%
Dyspnoea
8%
White blood cell count decreased
7%
Alopecia
4%
Cholangitis
4%
General physical health deterioration
3%
Pneumonia
3%
Pulmonary embolism
2%
Bile duct obstruction
2%
Cholangitis acute
2%
Jaundice cholestatic
1%
Bile duct stenosis
1%
Urinary tract infection
1%
Dehydration
1%
Hypokalaemia
1%
Gastrointestinal haemorrhage
1%
Subileus
1%
Upper gastrointestinal haemorrhage
1%
Hyperbilirubinaemia
1%
Gastric perforation
1%
Blood bilirubin increased
1%
Hyperglycaemia
1%
Embolism
1%
Device related infection
1%
Device related sepsis
1%
Hypoalbuminaemia
1%
Chills
1%
Atrial fibrillation
1%
Cardiac failure
1%
Infection
1%
Sepsis
1%
Cancer pain
1%
Depression
1%
Deep vein thrombosis
1%
Duodenal obstruction
1%
Duodenal stenosis
1%
Intestinal obstruction
1%
Obstruction gastric
1%
Cholecystitis
1%
Cholestasis
1%
Renal failure
1%
Gamma-glutamyltransferase increased
1%
Disease progression
1%
Jaundice
1%
Pain
1%
Biliary sepsis
1%
Biliary tract infection
1%
Bronchopneumonia
1%
Cellulitis
1%
Gastrointestinal obstruction
1%
Haematemesis
1%
Ileus
1%
Small intestinal obstruction
1%
Ascites
100%
80%
60%
40%
20%
0%
Study treatment Arm
TH-302
Placebo

TH-CR-410 Trial Design

1Treatment groups
Experimental Treatment
Group I: TH-302 Dose escalationExperimental Treatment1 Intervention
The initial dose of TH-302 will be 240 mg/m2. A Dose Level minus 1 and 2 will be built into the study in the event that subjects experience excessive toxicity at Dose Level 1. Dose escalation will continue with approximately 40% increases from the previous dose level; however lower dose increases of 20-39% may be implemented after consultation between the Investigators, Medical Monitor and Sponsor with the percent increase dependent on the current dose level and the cumulative safety data.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Evofosfamide
Not yet FDA approved

Find a Location

Who is running the clinical trial?

Threshold PharmaceuticalsLead Sponsor
32 Previous Clinical Trials
3,807 Total Patients Enrolled
Mohammed Milhem, MDPrincipal InvestigatorUniversity of Iowa
8 Previous Clinical Trials
205 Total Patients Enrolled
Alexander Starodub, MDPrincipal InvestigatorIU Health Goshen Center for Cancer Care

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Dose-Escalation Study of TH-302 in Combination With Sunitinib to Treat Patients With Advanced Renal Cell Carcinoma,Gastrointestinal Stromal Tumors and Pancreatic Neuroendocrine Tumors
2011. "Dose-Escalation Study of TH-302 in Combination With Sunitinib to Treat Patients With Advanced Renal Cell Carcinoma,Gastrointestinal Stromal Tumors and Pancreatic Neuroendocrine Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01381822.
All > Renal Cell Carcinoma > Neuroendocrine Tumor
~4 spots leftby Apr 2025
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