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CHR-2797

Phase 1

Advanced Solid Tumors | Small molecule | Oncology |United Therapeutics Corporation|Last Updated: Aug 6, 2010

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment41

FDA Designations

No designations recorded

Clinical trial landscape

CHR-2797 · 1 trial · 1 indication

Phase 1 1
NCT00692354Safety Study to Evaluate CHR-2797 in Patients With Advanced TumoursAdvanced Solid Tumors
COMPLETED41 Analytics
PHASE1COMPLETED
Safety Study to Evaluate CHR-2797 in Patients With Advanced Tumours
Advanced Solid TumorsUnlock trial analytics

Study Endpoints

Primary Endpoints

To determine the safety, tolerability, dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of CHR-2797 when administered orally, once daily, to patients with advanced solid tumours.
3 years

Secondary Endpoints

To determine the PK parameters for oral CHR-2797 at increasing dose levels;
3 years
To investigate the PD effects of CHR-2797 in blood and tumour cells
3 years
To enable a preliminary assessment of anti-tumour activity of CHR-2797
3 years
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
CHR-2797 (tosedostat)DRUGDrug was given orally, once daily, ensuring a dosing interval of approximately 24 hours. Dose escalations took place starting at 10mg and escalating (per protocol) as follows: 20, 40, 90, 130, 180, 240 and 320 mg
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Signed, informed consent * Histological or cytologically confirmed malignant solid tumour refractory to standard therapy or for which no standard therapy exists * Evaluable disease * Recovered from the acute adverse effects of prior therapies (excluding alopecia and grade 1 ne...

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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Advanced Solid Tumors")

Frequently asked questions about CHR-2797

What is CHR-2797 used for?

CHR-2797 is an investigational small molecule being studied for the treatment of advanced solid tumors. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being evaluated in patients with advanced solid tumors to assess its safety and potential therapeutic effects.

Who makes CHR-2797?

CHR-2797 is being developed by United Therapeutics Corporation, a biotechnology company traded on the NASDAQ under the ticker symbol UTHR. The company is conducting clinical research on this investigational oncology drug for the treatment of advanced solid tumors.

What phase is CHR-2797 in?

CHR-2797 is in Phase 1 clinical development. It is an investigational drug for advanced solid tumors and has not yet received regulatory approval. The Phase 1 trial has been completed, and the drug remains in early-stage clinical investigation.

What clinical trials is CHR-2797 in?

CHR-2797 has been studied in one clinical trial, identified as NCT00692354, titled "Safety Study to Evaluate CHR-2797 in Patients With Advanced Tumours." This Phase 1 study enrolled 41 participants with advanced solid tumors and has been completed. The trial was uncontrolled and not randomized or double-blinded.

Is CHR-2797 FDA approved?

CHR-2797 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for advanced solid tumors. The completed Phase 1 trial assessed safety, but the drug has not yet received marketing approval from the FDA or other regulatory agencies.