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Study of AG-120 in Previously Treated Advanced Cholangiocarcinoma With IDH1 Mutations (ClarIDHy) (ClarIDHy)

This study is currently recruiting participants.
See Contacts and Locations
Verified November 2016 by Agios Pharmaceuticals, Inc.
Sponsor:
Information provided by (Responsible Party):
Agios Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT02989857
First received: December 5, 2016
Last updated: August 21, 2017
Last verified: November 2016
December 5, 2016
August 21, 2017
December 2016
November 2019   (Final data collection date for primary outcome measure)
Progression Free Survival (PFS) [ Time Frame: Up to 26 weeks, on average ]
Same as current
Complete list of historical versions of study NCT02989857 on ClinicalTrials.gov Archive Site
  • Adverse Event (AE) and Serious Adverse Event (SAE) analysis [ Time Frame: Up to 26 weeks, on average ]
  • Overall Survival (OS) [ Time Frame: Up to 52 weeks, on average ]
  • Overall Response Rate (ORR) [ Time Frame: Up to 26 weeks, on average ]
  • Quality of Life (QOL) [ Time Frame: Up to 52 weeks, on average ]
    Method of assessment will be questionnaires. Questionnaire: EORTC QLQ-C30
  • Quality of Life (QOL) [ Time Frame: Up to 52 weeks, on average ]
    Method of assessment will be questionnaires. Questionnaire: EORTC QLQ-Bil21
  • Quality of Life (QOL) [ Time Frame: Up to 26 weeks, on average ]
    Method of assessment will be questionnaires. Questionnaire: EuroQOL EQ-5D-5L
  • Adverse Event (AE) and Serious Adverse Event (SAE) analysis [ Time Frame: Up to 26 weeks, on average ]
  • Overall Survival (OS) [ Time Frame: Up to 52 weeks, on average ]
  • Overall Response Rate (ORR) [ Time Frame: Up to 26 weeks, on average ]
  • Quality of Life (QOL) [ Time Frame: Up to 52 weeks, on average ]
    Method of assessment will be questionnaires
Not Provided
Not Provided
 
Study of AG-120 in Previously Treated Advanced Cholangiocarcinoma With IDH1 Mutations (ClarIDHy)
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-controlled Study of AG-120 in Previously-treated Subjects With Nonresectable or Metastatic Cholangiocarcinoma With an IDH1 Mutation
Study AG120-C-005 is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study of orally administered AG-120. Subjects, all personnel involved in the evaluation of subjects' response to treatment (e.g., Investigators, study coordinators, study pharmacists), and designated Sponsor team members will be blinded to study treatment. Subjects are required to have a histologically-confirmed diagnosis of IDH1 gene-mutated cholangiocarcinoma that is not eligible for curative resection, transplantation, or ablative therapies prior to enrollment.IDH1 mutation testing will be performed at participating investigative sites. Subjects must have progression of disease and have received at least 1 but not more than 2 prior treatment regimens for advanced disease (nonresectable or metastatic). All subjects must have received either a gemcitabine or a 5 fluorouracil (5-FU) based chemotherapy regimen.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Advanced Cholangiocarcinoma
  • Metastatic Cholangiocarcinoma
  • Drug: AG-120
  • Drug: AG-120 matched placebo
  • Active Comparator: AG-120 experimental study drug
    AG-120, 500mg daily continuous dosing
    Intervention: Drug: AG-120
  • Placebo Comparator: AG-120 matched placebo
    AG-120 matched placebo, daily continuous dosing. Subjects who experience disease progression and were receiving placebo, will be allowed to cross-over and receive AG-120
    Intervention: Drug: AG-120 matched placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
186
August 2020
November 2019   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Be ≥18 years of age.
  2. Have a histopathological diagnosis (fresh or banked tumor biopsy sample, preferably collected within the last 3 years) of nonresectable or metastatic cholangiocarcinoma and are not eligible for curative resection, transplantation, or ablative therapies.
  3. Have documented IDH1 gene-mutated disease (from a fresh tumor biopsy or the most recent banked tumor tissue available) based on central laboratory testing (R132C/L/G/H/S mutation variants tested).
  4. Have an ECOG PS score of 0 or 1
  5. Have an expected survival of ≥3 months.
  6. Have at least one evaluable and measurable lesion as defined by RECIST v1.1. Subjects who have received prior local therapy (including but not limited to embolization, chemoembolization, radiofrequency ablation, or radiation therapy) are eligible provided measurable disease falls outside of the treatment field or within the field and has shown ≥20% growth in size since post-treatment assessment.
  7. Have documented disease progression following at least 1 and no more than 2 prior systemic regimens for advanced disease (nonresectable or metastatic). Subjects must have received at least 1 gemcitabine- or 5-FU-containing regimen for advanced cholangiocarcinoma. Subjects who have received systemic adjuvant chemotherapy will be permitted provided there is documented disease progression during or within 6 months of completing the therapy.

Exclusion criteria:

  1. Received a prior IDH inhibitor.
  2. Received systemic anticancer therapy or an investigational agent <2 weeks prior to Day 1 (washout from prior immune based anticancer therapy is 4 weeks). In addition, the first dose of study treatment should not occur before a period ≥5 half-lives of the investigational agent has elapsed.
  3. Received radiotherapy to metastatic sites of disease <2 weeks prior to Day 1.
  4. Underwent hepatic radiation, chemoembolization, and radiofrequency ablation <4 weeks prior to Day 1.
  5. Have known symptomatic brain metastases requiring steroids. Subjects with previously diagnosed brain metastases are eligible if they have completed their treatment and have recovered from the acute effects of radiation therapy or surgery prior to study entry, have discontinued corticosteroid treatment for these metastases for at least 4 weeks and have radiographically stable disease for at least 3 months prior to study entry. Note: up to 10 mg per day of prednisone equivalent will be allowed.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Medical Affairs Agios Pharmaceuticals, Inc. 844-633-2332 Medinfo@agios.com
Spain,   United States
 
 
NCT02989857
AG120-C-005
Yes
Not Provided
Plan to Share IPD: No
Agios Pharmaceuticals, Inc.
Agios Pharmaceuticals, Inc.
Not Provided
Study Chair: Medical Affairs Agios Pharmaceuticals, Inc. Agios Pharmaceuticals, Inc.
Agios Pharmaceuticals, Inc.
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP