Open-Label, Dose-Escalation Study of Pemigatinib in Subjects With Advanced Malignancies - (FIGHT-101)

NCT02393248 | Terminated Phase 1 Results FDA Drug

• 1 other identifier: INCB 54828-101
• Study Type: interventional
• Target: 201
• Locations: 2 countries
• Sites: 20

Brief Summary

The purpose of this study will be to evaluate the safety, tolerability, and pharmacological activity of pemigatinib in subjects with advanced malignancies. This study will have three parts, dose escalation (Part 1), dose expansion (Part 2) and combination therapy (Part 3).

Conditions

Lung Cancer; Solid Tumor; Gastric Cancer; Urothelial Cancer; Endometrial Cancer; Multiple Myeloma; Myeloproliferative Neoplasms; Breast Cancer; Cholangiocarcinoma; UC; MPN

Keywords

alterations in FGF or FGFR; squamous non-small cell lung cancer; gastric cancer; urothelial cancer; endometrial cancer; multiple myeloma; MPN

Outcome Measures

Primary Outcomes (6)

• Parts 1 and 2 Combined: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)

  Adverse events were defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occurred after a participant provided informed consent. Abnormal laboratory values or test results that occurred after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or required changes in the study drug(s). TEAEs were defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug.

  up to 763 days

• Part 3: Number of Participants With Any TEAE

  Adverse events were defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occurred after a participant provided informed consent. Abnormal laboratory values or test results that occurred after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or required changes in the study drug(s). TEAEs were defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug.

  up to 869 days

• E0 Following Once Daily Dosing of Pemigatinib as Monotherapy in Parts 1 and 2

  E0 was defined as the Baseline serum concentration of phosphate.

  predose on Days 1 and 14 of Cycle 1; anytime during visit on Day 1 of Cycle 2 and all subsequent cycles

• EC50 Following Once Daily Dosing of Pemigatinib as Monotherapy in Parts 1 and 2

  EC50 was defined as the pemigatinib steady-state area under the plasma or serum concentration-time curve that increases 50% of serum phosphate.

  predose on Days 1 and 14 of Cycle 1; anytime during visit on Day 1 of Cycle 2 and all subsequent cycles

• Emax Following Once Daily Dosing of Pemigatinib as Monotherapy in Parts 1 and 2

  Emax was defined as the maximum degree of increasing of serum phosphate by pemigatinib.

  predose on Days 1 and 14 of Cycle 1; anytime during visit on Day 1 of Cycle 2 and all subsequent cycles

• Highest Serum Phosphate Concentration Following Pemigatinib as Monotherapy in Parts 1 and 2

  Serum phosphate concentration was assessed throughout Parts 1 and 2.

  predose on Days 1 and 14 of Cycle 1; anytime during visit on Day 1 of Cycle 2 and all subsequent cycles

Secondary Outcomes (33)

• Part 2: Overall Response Rate (ORR)

  up to 126 days

• Part 3: ORR

  up to 203 days

• Parts 1 and 2: Cmax After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Day 1

  Part 1: predose; 0.5, 1, 2, 4, 6, and 8 hours post-dose post-dose on Cycle 1 Day 1. Part 2: predose on Cycle 1 Day 1

• Parts 1 and 2: Tmax After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Day 1

  Part 1: predose; 0.5, 1, 2, 4, 6, and 8 hours post-dose post-dose on Cycle 1 Day 1. Part 2: predose on Cycle 1 Day 1

• Parts 1 and 2: AUClast After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Day 1

  Part 1: predose; 0.5, 1, 2, 4, 6, and 8 hours post-dose post-dose on Cycle 1 Day 1. Part 2: predose on Cycle 1 Day 1

Study Arms (25)

Part 1: Intermittent pemigatinib 1/2/4 mg QD

EXPERIMENTAL

Participants self-administered oral pemigatinib 1/2/4 milligrams (mg) once daily (QD) on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break.

Drug: Pemigatinib

Part 1: Intermittent pemigatinib 6 mg QD

EXPERIMENTAL

Participants self-administered oral pemigatinib 6 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break.

Drug: Pemigatinib

Part 1: Intermittent pemigatinib 9 mg QD

EXPERIMENTAL

Participants self-administered oral pemigatinib 9 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break.

Drug: Pemigatinib

Part 1: Intermittent pemigatinib 13.5 mg QD

EXPERIMENTAL

Participants self-administered oral pemigatinib 13.5 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break.

Drug: Pemigatinib

Part 1: Intermittent pemigatinib 20 mg QD

EXPERIMENTAL

Participants self-administered oral pemigatinib 20 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break.

Drug: Pemigatinib

Part 1: Continuous pemigatinib 9 mg QD

EXPERIMENTAL

Participants self-administered oral pemigatinib 9 mg QD on Days 1 through 21 of each 21-day cycle.

Drug: Pemigatinib

Part 1: Continuous pemigatinib 13.5 mg QD

EXPERIMENTAL

Participants self-administered oral pemigatinib 13.5 mg QD on Days 1 through 21 of each 21-day cycle.

Drug: Pemigatinib

Part 1: Continuous pemigatinib 20 mg QD

EXPERIMENTAL

Participants self-administered oral pemigatinib 20 mg QD on Days 1 through 21 of each 21-day cycle.

Drug: Pemigatinib

Part 1: Continuous pemigatinib 7.5 mg BID

EXPERIMENTAL

Participants self-administered oral pemigatinib 7.5 mg twice daily (BID) on Days 1 through 21 of each 21-day cycle.

Drug: Pemigatinib

Part 1: Continuous pemigatinib 10 mg BID

EXPERIMENTAL

Participants self-administered oral pemigatinib 10 mg BID on Days 1 through 21 of each 21-day cycle.

Drug: Pemigatinib

Part 2: Intermittent pemigatinib 9 mg QD

EXPERIMENTAL

Participants self-administered oral pemigatinib 9 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break.

Drug: Pemigatinib

Part 2: Intermittent pemigatinib 13.5 mg QD

EXPERIMENTAL

Participants self-administered oral pemigatinib 13.5 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break.

Drug: Pemigatinib

Part 2: Continuous pemigatinib 9 mg QD

EXPERIMENTAL

Participants self-administered oral pemigatinib 9 mg QD on Days 1 through 21 of each 21-day cycle.

Drug: Pemigatinib

Part 2: Continuous pemigatinib 13.5 mg QD

EXPERIMENTAL

Participants self-administered oral pemigatinib 13.5 mg QD on Days 1 through 21 of each 21-day cycle.

Drug: Pemigatinib

Part 2: Continuous pemigatinib 20 mg QD

EXPERIMENTAL

Participants self-administered oral pemigatinib 20 mg QD on Days 1 through 21 of each 21-day cycle.

Drug: Pemigatinib

Part 3: Gem/Cis/intermittent pemigatinib 9 mg

EXPERIMENTAL

Participants received gemcitabine (Gem) intravenously starting at 1000 mg/meters squared (m\^2) (30 minutes) on Days 1 and 8 of each 21-day cycle. Cisplatin (Cis) was administered intravenously starting at 70 mg/m\^2 (1-4 hours) once every 3 weeks on Day 1 of each 21-day cycle. Both gemcitabine and cisplatin doses could have been adjusted for toxicity management per commercial labeling. The investigator could have interrupted, modified, or discontinued chemotherapy with medical monitor approval. Participants self-administered oral pemigatinib 9 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. It was permissible to continue pemigatinib administration during the toxicity break of gemcitabine/cisplatin.

Drug: Pemigatinib; Drug: Gemcitabine; Drug: Cisplatin

Part 3: Gem/Cis/intermittent pemigatinib 13.5 mg

EXPERIMENTAL

Participants received gemcitabine intravenously starting at 1000 mg/m\^2 (30 minutes) on Days 1 and 8 of each 21-day cycle. Cisplatin was administered intravenously starting at 70 mg/m\^2 (1-4 hours) once every 3 weeks on Day 1 of each 21-day cycle. Both gemcitabine and cisplatin doses could have been adjusted for toxicity management per commercial labeling. The investigator could have interrupted, modified, or discontinued chemotherapy with medical monitor approval. Participants self-administered oral pemigatinib 13.5 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. It was permissible to continue pemigatinib administration during the toxicity break of gemcitabine/cisplatin.

Drug: Pemigatinib; Drug: Gemcitabine; Drug: Cisplatin

Part 3: Tras/intermittent pemigatinib 13.5 mg

EXPERIMENTAL

Trastuzumab (Tras) was administered as an open-label, commercial product at an initial dose of 8 mg/kilograms (kg) over a 90-minute intravenous infusion, followed by 6 mg/kg over a 30- to 90-minute intravenous infusion once every 3 weeks. The dose could have been adjusted for toxicity management, per commercial labeling. The investigator could have interrupted, modified, or discontinued trastuzumab with medical monitor approval. Participants self-administered oral pemigatinib 13.5 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. It was permissible to continue pemigatinib administration during the toxicity break of trastuzumab.

Drug: Pemigatinib; Drug: Trastuzumab

Part 3: Doc/intermittent pemigatinib 13.5 mg

EXPERIMENTAL

Participants received docetaxel (Doc) intravenously starting at 75 mg/m\^2 (1 hour) once every 3 weeks on Day 1 of each cycle. The dose could have been adjusted for toxicity management per commercial labeling. The investigator could have interrupted, modified, or discontinued chemotherapy with medical monitor approval. Participants self-administered oral pemigatinib 13.5 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. It was permissible to continue pemigatinib administration during the toxicity break of docetaxel.

Drug: Pemigatinib; Drug: Docetaxel

Part 3: Pem/intermittent pemigatinib 9 mg

EXPERIMENTAL

Participants received pembrolizumab (Pem) intravenously at 200 mg (30 minutes) once every 3 weeks on Day 1 of each cycle. The dose could have been adjusted for toxicity management per commercial labeling. The investigator could have interrupted, modified, or discontinued pembrolizumab with medical monitor approval. Participants self-administered oral pemigatinib 9 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. It was permissible to continue pemigatinib administration during the toxicity break of pembrolizumab.

Drug: Pemigatinib; Drug: Pembrolizumab

Part 3: Pem/intermittent pemigatinib 13.5 mg

EXPERIMENTAL

Participants received pembrolizumab intravenously at 200 mg (30 minutes) once every 3 weeks on Day 1 of each cycle. The dose could have been adjusted for toxicity management per commercial labeling. The investigator could have interrupted, modified, or discontinued pembrolizumab with medical monitor approval. Participants self-administered oral pemigatinib 13.5 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. It was permissible to continue pemigatinib administration during the toxicity break of pembrolizumab.

Drug: Pemigatinib; Drug: Pembrolizumab

Part 3: Pem/continuous pemigatinib 13.5 mg

EXPERIMENTAL

Participants received pembrolizumab intravenously at 200 mg (30 minutes) once every 3 weeks on Day 1 of each cycle. The dose could have been adjusted for toxicity management per commercial labeling. The investigator could have interrupted, modified, or discontinued pembrolizumab with medical monitor approval. Participants self-administered oral pemigatinib 13.5 mg QD on Days 1 through 21 of each 21-day cycle. It was permissible to continue pemigatinib administration during the toxicity break of pembrolizumab.

Drug: Pemigatinib; Drug: Pembrolizumab

Part 3: Ref/continuous pemigatinib 9 mg

EXPERIMENTAL

Retifanlimab (Ref) was administered once every 4 weeks on a 28-day cycle as an open-label product, at an initial dose of 500 mg over a 60-minute intravenous infusion. Participants self-administered oral pemigatinib 9 mg QD on Days 1 through 21 of each 21-day cycle.

Drug: Pemigatinib; Drug: Retifanlimab

Part 3: Ref/continuous pemigatinib 13.5 mg

EXPERIMENTAL

Retifanlimab was administered once every 4 weeks on a 28-day cycle as an open-label product, at an initial dose of 500 mg over a 60-minute intravenous infusion. Participants self-administered oral pemigatinib 13.5 mg QD on Days 1 through 21 of each 21-day cycle.

Drug: Pemigatinib; Drug: Retifanlimab

Part 3: Ref/continuous pemigatinib 20 mg

EXPERIMENTAL

Retifanlimab was administered once every 4 weeks on a 28-day cycle as an open-label product, at an initial dose of 500 mg over a 60-minute intravenous infusion. Participants self-administered oral pemigatinib 20 mg QD on Days 1 through 21 of each 21-day cycle.

Drug: Pemigatinib; Drug: Retifanlimab

Interventions

Pemigatinib DRUG

Also known as: INCB054828

Part 1: Continuous pemigatinib 10 mg BID; Part 1: Continuous pemigatinib 13.5 mg QD; Part 1: Continuous pemigatinib 20 mg QD; Part 1: Continuous pemigatinib 7.5 mg BID; Part 1: Continuous pemigatinib 9 mg QD; Part 1: Intermittent pemigatinib 1/2/4 mg QD; Part 1: Intermittent pemigatinib 13.5 mg QD; Part 1: Intermittent pemigatinib 20 mg QD; Part 1: Intermittent pemigatinib 6 mg QD; Part 1: Intermittent pemigatinib 9 mg QD; Part 2: Continuous pemigatinib 13.5 mg QD; Part 2: Continuous pemigatinib 20 mg QD; Part 2: Continuous pemigatinib 9 mg QD; Part 2: Intermittent pemigatinib 13.5 mg QD; Part 2: Intermittent pemigatinib 9 mg QD; Part 3: Doc/intermittent pemigatinib 13.5 mg; Part 3: Gem/Cis/intermittent pemigatinib 13.5 mg; Part 3: Gem/Cis/intermittent pemigatinib 9 mg; Part 3: Pem/continuous pemigatinib 13.5 mg; Part 3: Pem/intermittent pemigatinib 13.5 mg; Part 3: Pem/intermittent pemigatinib 9 mg; Part 3: Ref/continuous pemigatinib 13.5 mg; Part 3: Ref/continuous pemigatinib 20 mg; Part 3: Ref/continuous pemigatinib 9 mg; Part 3: Tras/intermittent pemigatinib 13.5 mg

Gemcitabine DRUG

Part 3: Gem/Cis/intermittent pemigatinib 13.5 mg; Part 3: Gem/Cis/intermittent pemigatinib 9 mg

Pembrolizumab DRUG

Part 3: Pem/continuous pemigatinib 13.5 mg; Part 3: Pem/intermittent pemigatinib 13.5 mg; Part 3: Pem/intermittent pemigatinib 9 mg

Docetaxel DRUG

Part 3: Doc/intermittent pemigatinib 13.5 mg

Trastuzumab DRUG

Part 3: Tras/intermittent pemigatinib 13.5 mg

Retifanlimab DRUG

Also known as: INCMGA00012

Part 3: Ref/continuous pemigatinib 13.5 mg; Part 3: Ref/continuous pemigatinib 20 mg; Part 3: Ref/continuous pemigatinib 9 mg

Cisplatin DRUG

Part 3: Gem/Cis/intermittent pemigatinib 13.5 mg; Part 3: Gem/Cis/intermittent pemigatinib 9 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects, age 18 years or older on day of signing consent
• Part 1: Any advanced solid tumor malignancy; Part 2: Subjects with squamous non-small cell lung cancer, cholangiocarcinoma/gastric cancer, urothelial cancer, breast/endometrial cancer, multiple myeloma, or MPNs that have a tumor or malignancy that has been evaluated and confirmed to harbor genetic alterations in FGF or FGFR genes. A subject's fibroblast growth factor (FGF) or fibroblast growth factor receptor (FGFR) alteration may be based on local or central laboratory results. Part 3: Dose finding: subjects with solid tumor malignancies who qualify for combo therapy; dose-expansion: FGF/FGFR+ subjects qualified to receive combo therapy
• Has progressed after prior therapy and there is no further effective standard anticancer therapy available (including subject refuses or is intolerant)
• Life expectancy \> 12 weeks
• Eastern Cooperative Oncology Group (ECOG) performance status:
• Part 1: 0 or 1
• Part 2 and 3: 0, 1, or 2

You may not qualify if:

• Treatment with other investigational study drug for any indication for any reason, or receipt of anticancer medications within 21 days or 5 half-lives before first dose of study drug
• Prior receipt of a selective FGFR inhibitor
• History of a calcium/phosphate homeostasis disorder
• History and/or current evidence of ectopic mineralization/calcification
• Current evidence of corneal disorder/keratopathy
• Has a history or presence of inadequate liver, renal, hematopoietic and/or cardiac function parameters outside protocol-defined range
• Prior radiotherapy within 2 weeks of study treatment

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (20)

University of Alabama At Birmingham Comprehensive Cancer Center

Birmingham, Alabama, 35205, United States

Location

Cedars-Sinai Medical Center

West Hollywood, California, 90048, United States

Location

Yale Cancer Center

New Haven, Connecticut, 06510, United States

Location

Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

Location

Hematology Oncology Associates of the Tr

Port Saint Lucie, Florida, 34952, United States

Location

Emory University - Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

John Theurer Cancer Center, Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Northwell Health - Monter Cancer Center

New Hyde Park, New York, 11042, United States

Location

Montefiore Medical Center

The Bronx, New York, 10461, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Ohio State University - Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

Signal Point Clinical Research Center

Middletown, Ohio, 45042, United States

Location

Greenville Health System Cancer Institute

Greenville, South Carolina, 29605, United States

Location

Mary Crowley Cancer Research Ctr

Dallas, Texas, 75230, United States

Location

Md Anderson Cancer Center

Houston, Texas, 77030, United States

Location

South Texas Accelerated Research Therapeutics

San Antonio, Texas, 78229, United States

Location

Baylor Scott & White Health

Temple, Texas, 76508, United States

Location

The Finsen Centre National Hospital

Copenhagen, 02100, Denmark

Location

Related Publications (2)

• Subbiah V, Iannotti NO, Gutierrez M, Smith DC, Feliz L, Lihou CF, Tian C, Silverman IM, Ji T, Saleh M. FIGHT-101, a first-in-human study of potent and selective FGFR 1-3 inhibitor pemigatinib in pan-cancer patients with FGF/FGFR alterations and advanced malignancies. Ann Oncol. 2022 May;33(5):522-533. doi: 10.1016/j.annonc.2022.02.001. Epub 2022 Feb 14.

  PMID: 35176457 DERIVED

• Gong X, Ji T, Liu X, Chen X, Yeleswaram S. Evaluation of the clinical cardiac safety of pemigatinib, a fibroblast growth factor receptor inhibitor, in participants with advanced malignancies. Pharmacol Res Perspect. 2022 Feb;10(1):e00906. doi: 10.1002/prp2.906.

  PMID: 34951522 DERIVED

MeSH Terms

Conditions

Lung Neoplasms; Stomach Neoplasms; Endometrial Neoplasms; Multiple Myeloma; Myeloproliferative Disorders; Breast Neoplasms; Cholangiocarcinoma

Interventions

pemigatinib; Gemcitabine; pembrolizumab; Docetaxel; Trastuzumab; Cisplatin

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Bone Marrow Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Results Point of Contact

• Title: Study Director
• Organization: Incyte Corporation

medinfo@incyte.com

1-855-463-3463

Study Officials

• Luis Féliz, MD

  Incyte Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: January 30, 2015
• First Posted: March 19, 2015
• Study Start: February 27, 2015
• Primary Completion: December 17, 2021
• Study Completion: December 17, 2021
• Last Updated: January 6, 2023
• Results First Posted: January 6, 2023

Record last verified: 2022-12

Locations

US (19); DK (1)