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

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ClinicalTrials.gov Identifier: NCT02989857
Recruitment Status : Active, not recruiting
First Posted : December 12, 2016
Last Update Posted : October 11, 2019
Sponsor:
Information provided by (Responsible Party):
Agios Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE December 5, 2016
First Posted Date  ICMJE December 12, 2016
Last Update Posted Date October 11, 2019
Actual Study Start Date  ICMJE January 2017
Actual Primary Completion Date January 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 8, 2016)
Progression Free Survival (PFS) [ Time Frame: Up to 26 weeks, on average ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02989857 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 13, 2017)
  • 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 52 weeks, on average ]
    Method of assessment will be questionnaires. Questionnaire: PGI-C/PGI-S
  • Health Economic Outcomes [ Time Frame: Up to 26 weeks, on average ]
    Method of assessment will be questionnaires. Questionnaire: EuroQOL EQ-5D-5L
Original Secondary Outcome Measures  ICMJE
 (submitted: December 8, 2016)
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of AG-120 in Previously Treated Advanced Cholangiocarcinoma With IDH1 Mutations (ClarIDHy)
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Patients randomized in a 2:1 allocation (AG-120 vs Placebo)
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Advanced Cholangiocarcinoma
  • Metastatic Cholangiocarcinoma
Intervention  ICMJE
  • Drug: AG-120
  • Drug: AG-120 matched placebo
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: December 8, 2016)
186
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2020
Actual Primary Completion Date January 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   Italy,   Korea, Republic of,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02989857
Other Study ID Numbers  ICMJE AG120-C-005
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Agios Pharmaceuticals, Inc.
Study Sponsor  ICMJE Agios Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Medical Affairs Agios Pharmaceuticals, Inc. Agios Pharmaceuticals, Inc.
PRS Account Agios Pharmaceuticals, Inc.
Verification Date October 2019

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