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ADH-1

Phase 2

Neoplasms | Small Molecules | Oncology |Fennec Pharmaceuticals Inc.|Trials Updated: Dec 28, 2023

ADH-1 development status

Highest phase Phase 2
Registered trials 2 across 2 sponsors since Apr 2001

ADH-1 target and mechanism

ModalitySmall Molecules

Also known as ADH -1 (Exherin™), Exherin

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials5
Total Enrollment73

FDA Designations

No designations recorded

ADH-1 clinical trials

ADH-1 · 5 trials · 21 indications

Phase 2 1Phase 1/2 2Phase 1 2
NCT00264433A Study of the Safety and Effects of ADH-1 Given Intravenously as a Single AgentNeoplasms
COMPLETED- Analytics
PHASE2COMPLETED
A Study of the Safety and Effects of ADH-1 Given Intravenously as a Single Agent
NeoplasmsUnlock trial analytics

Study Endpoints

Primary Endpoints

To tabulate the Best Overall Response according to unconfirmed RECIST, modified for cutaneous lesions
By Week 12
Recommended dose of ADH-1, defined as the highest dose tested which results in dose-limiting toxicities in no more than 1 of 6 evaluable patients based on the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
21 days

The incidence rates of adverse events will be described by dose level. The frequency of occurrence of overall toxicity, categorized by toxicity grades, will be described.

Secondary Endpoints

Changes in the levels of ICAM-1, E-selectin, VEGF, soluble VEGFR and B-FGF
After all patients complete cycle 1, about 2 years after initial patient enrolled
Progression-free survival
From the first date of therapy until the first notation of clinical progression, relapse or death from any cause, assessed up to 2 years
Survival
From the first date of therapy until the date of death from any cause, assessed up to 2 years
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Treatment (ADH-1, cisplatin, gemcitabine hydrochloride)EXPERIMENTALPatients receive ADH-1 IV over 20-80 minutes on days 1, 4, 8, 11, 15, and 18, cisplatin IV and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responsive disease may receive maintenance therapy with cisplatin and gemcitabine hydrochloride.

Interventions

NameTypeDescription
ADH -1 (Exherin™)DRUG -
ADH-1DRUG4 gm IV Days 1 and 8
melphalanDRUGBy Isolated Limb Infusion (ILI), Lower Extremity: 7.5 mg/L (Limb Volume), Day 1 or Upper Extremity: 10 mg/L (Limb Volume), Day 1
ADH -1 and carboplatinDRUG -
ADH -1 and docetaxelDRUG -
ADH -1 and capecitabineDRUG -
CisplatinDRUGGiven IV
Gemcitabine HydrochlorideDRUGGiven IV
Laboratory Biomarker AnalysisOTHERCorrelative studies
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites11

Inclusion Criteria: * Signed written informed consent * Male and female patients \> or = 18 years of age with a solid tumor(s) refractory to standard curative therapy or for which no curative therapy exists * Histologically proven advanced and/or metastatic solid tumor of one of the following histo...

Countries:United StatesCanadaItalySwitzerland
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Frequently asked questions about ADH-1

What is ADH-1?

ADH-1 is an investigational small molecule developed by Fennec Pharmaceuticals Inc. (ticker FENC) for oncology indications. It has been studied in Phase 1 clinical trials in patients with solid tumors and neoplasms, including Ampulla of Vater adenocarcinoma. All four of its recorded trials are completed, and it is not currently listed as an active development program.

What is ADH-1 used for in Ampulla of Vater adenocarcinoma?

ADH-1 has been studied in Phase 1 trials for Ampulla of Vater adenocarcinoma and other neoplasms. One trial, NCT01825603, evaluated ADH-1 with gemcitabine hydrochloride and cisplatin in metastatic pancreatic or biliary tract cancer, a group that includes Ampulla of Vater adenocarcinoma. The drug remains investigational and is not approved for this indication.

Who makes ADH-1?

ADH-1 is developed by Fennec Pharmaceuticals Inc., which trades under the ticker FENC. The company sponsored the Phase 1 clinical trials of ADH-1 in solid tumors and neoplasms, including studies combining the agent with chemotherapy such as gemcitabine, cisplatin, melphalan, carboplatin, docetaxel, or capecitabine.

What phase is ADH-1 in?

ADH-1 is in Phase 1 development. All four of its recorded clinical trials are Phase 1 studies, and all four are completed, with no active trials listed. The drug is investigational and has not been approved by the FDA for any indication.

What clinical trials is ADH-1 in?

ADH-1 has been studied in four completed Phase 1 trials: NCT01825603 with gemcitabine and cisplatin in pancreatic or biliary tract cancer, NCT00421811 with normothermic isolated limb infusion of melphalan, NCT00390676 with carboplatin, docetaxel, or capecitabine, and NCT00265057 as an intravenous agent in solid tumors. Total recorded enrollment is 56 patients.

Is ADH-1 the same as Exherin?

Yes, ADH-1 is also known as Exherin, and it has been referred to as ADH-1 and carboplatin in combination studies. These names refer to the same investigational small molecule developed by Fennec Pharmaceuticals Inc. for oncology indications, so searches for Exherin and ADH-1 lead to the same drug asset.