A Phase 1 Study of Pegilodecakin (LY3500518) in Participants With Advanced Solid Tumors

NCT02009449 | Completed Phase 1 Results FDA Drug

• 3 other identifiers: 17159J1L-AM-JZGAAM0010-001
• Study Type: interventional
• Target: 353
• Locations: 1 country
• Sites: 10

Brief Summary

This is a first-in-human, open-label, dose escalation study to evaluate the safety and tolerability of pegilodecakin in participants with advanced solid tumors, dosed daily subcutaneously as a monotherapy or in combination with chemotherapy or immunotherapy.

Conditions

Melanoma; Prostate Cancer; Ovarian Cancer; Renal Cell Carcinoma; Colorectal Carcinoma; Pancreatic Carcinoma; Non-small Cell Lung Carcinoma; Solid Tumors; Breast Cancer

Keywords

Phase 1/Phase 1b; Oncology; Cancer; Solid Tumors

Outcome Measures

Primary Outcomes (2)

• Number of Participants With TEAEs and SAEs Observed During the Study of Pegilodecakin

  The number of participants who experienced treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) during the study.

  From first dose of study drug through 30 days after the last dose of study drug (Up to 63 Months)

• Pharmacokinetic (PK): Serum Concentration of Pegilodecakin

  Serum concentration of Pegilodecakin is reported.

  Day 29

Secondary Outcomes (11)

• Number of Participants With Anti-Pegilodecakin Antibody Formation

  Up to 63 Months

• Part A: Number of Participants With Overall Response Rate (ORR)

  From Date of First Dose of study drug until Disease Progression or Death (Up to 54 months)

• Part B: Number of Participants With Overall Response Rate (ORR)

  From Date of First Dose of Study Drug until Disease Progression or Death (Up to 11 months)

• Part C: Number of Participants With Overall Response Rate (ORR)

  From Date of First Dose of Study drug until Disease Progression or Death (Upto 23 months)

• Part D: Number of Participants With Overall Response Rate (ORR)

  From Date of First Dose of Study Drug until Disease Progression or Death (Up to 7 months)

Study Arms (23)

Part A: Pegilodecakin 0.08/0.1 mg

EXPERIMENTAL

Participants received 0.08 or 0.1 mg of Pegilodecakin once daily (QD) administered subcutaneously (SC). Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.

Drug: Pegilodecakin

Part A: Pegilodecakin 0.2/0.25 mg

EXPERIMENTAL

Participants received 0.2 or 0.25 mg of Pegilodecakin QD administered SC. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.

Drug: Pegilodecakin

Part A: Pegilodecakin 0.4/0.5 mg

EXPERIMENTAL

Participants received 0.4 or 0.5 mg of Pegilodecakin QD administered SC. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.

Drug: Pegilodecakin

Part A: Pegilodecakin 0.8/1 mg

EXPERIMENTAL

Participants received 0.8 or 1 mg of Pegilodecakin QD administered SC. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.

Drug: Pegilodecakin

Part A: Pegilodecakin 1.6/2 mg

EXPERIMENTAL

Participants received 1.6 or 2 mg of Pegilodecakin QD administered SC. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.

Drug: Pegilodecakin

Part A: Pegilodecakin 3.2/4 mg

EXPERIMENTAL

Participants received 3.2 or 4 mg of Pegilodecakin QD administered SC. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.

Drug: Pegilodecakin

Part B: Pegilodecakin 0.2/0.25 mg + Platinum/Taxane

EXPERIMENTAL

Participants received 0.2 or 0.25 mg of Pegilodecakin QD administered SC along with Platinum/Taxane combination on Day 1 of each 21-day cycle for a maximum of 5 or 6 cycles. Participants received: Paclitaxel 200 or 175 mg/m² intravenously (IV) over 3 hours, or docetaxel 75 or 65 mg/m² IV over 1 hour, followed by carboplatin (AUC 6/5/4; max 6 × 150 mg) IV over 30 minutes or cisplatin 75 mg/m² IV over 6-8 hours. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.

Drug: Pegilodecakin; Drug: Paclitaxel or Docetaxel and Carboplatin or Cisplatin

Part B: Pegilodecakin 0.4/0.5 mg + Platinum/Taxane

EXPERIMENTAL

Participants received 0.4 or 0.5 mg of Pegilodecakin QD administered SC along with Platinum/Taxane combination on Day 1 of each 21-day cycle for a maximum of 5 or 6 cycles. Participants received: Paclitaxel 200 or 175 mg/m² intravenously (IV) over 3 hours, or docetaxel 75 or 65 mg/m² IV over 1 hour, followed by carboplatin (AUC 6/5/4; max 6 × 150 mg) IV over 30 minutes or cisplatin 75 mg/m² IV over 6-8 hours. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.

Drug: Pegilodecakin; Drug: Paclitaxel or Docetaxel and Carboplatin or Cisplatin

Part B: Pegilodecakin 0.8/1 mg + Platinum/Taxane

EXPERIMENTAL

Participants received 0.8 or 1 mg of Pegilodecakin QD administered SC along with Platinum/Taxane combination on Day 1 of each 21-day cycle for a maximum of 5 or 6 cycles. Participants received: Paclitaxel 200 or 175 mg/m² intravenously (IV) over 3 hours, or docetaxel 75 or 65 mg/m² IV over 1 hour, followed by carboplatin (AUC 6/5/4; max 6 × 150 mg) IV over 30 minutes or cisplatin 75 mg/m² IV over 6-8 hours. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.

Drug: Pegilodecakin; Drug: Paclitaxel or Docetaxel and Carboplatin or Cisplatin

Part C: Pegilodecakin 0.2/0.25 mg + FOLFOX

EXPERIMENTAL

Participants received 0.2 or 0.25 mg of Pegilodecakin QD administered SC and FOLFOX treatment on Day 1 of each 14-day cycle for a maximum of 12 cycles. Participants received: oxaliplatin 85 mg/m2 IV over 2 hours, and leucovorin 200 mg/m2 IV over 2 hours, followed by 5-Fluorouracil (FU) 400 mg/m2 IV bolus over 2-4 minutes, 5-FU 600 mg/m2/day IV over 22 hours, and leucovorin 200 mg/m2 over 2 hours on Day 2 followed by 5-FU 400 mg/m2 IV bolus over 2-4 minutes, and 5-FU 600 mg/m2/day IV over 22 hours. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.

Drug: Pegilodecakin; Drug: FOLFOX (Oxaliplatin/Leucovorin/5-Fluorouracil)

Part C: Pegilodecakin 0.4/0.5 mg + FOLFOX

EXPERIMENTAL

Participants received 0.4 or 0.5 mg of Pegilodecakin QD administered SC and FOLFOX treatment on Day 1 of each 14-day cycle for a maximum of 12 cycles. Participants received: oxaliplatin 85 mg/m2 IV over 2 hours, and leucovorin 200 mg/m2 IV over 2 hours, followed by 5-FU 400 mg/m2 IV bolus over 2-4 minutes, 5-FU 600 mg/m2/day IV over 22 hours, and leucovorin 200 mg/m2 over 2 hours on Day 2 followed by 5-FU 400 mg/m2 IV bolus over 2-4 minutes, and 5-FU 600 mg/m2/day IV over 22 hours. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.

Drug: Pegilodecakin; Drug: FOLFOX (Oxaliplatin/Leucovorin/5-Fluorouracil)

Part C: Pegilodecakin 0.8/1 mg + FOLFOX

EXPERIMENTAL

Participants received 0.8 or 1 mg of Pegilodecakin QD administered SC and FOLFOX treatment on Day 1 of each 14-day cycle for a maximum of 12 cycles. Participants received: oxaliplatin 85 mg/m2 IV over 2 hours, and leucovorin 200 mg/m2 IV over 2 hours, followed by 5-FU 400 mg/m2 IV bolus over 2-4 minutes, 5-FU 600 mg/m2/day IV over 22 hours, and leucovorin 200 mg/m2 over 2 hours on Day 2 followed by 5-FU 400 mg/m2 IV bolus over 2-4 minutes, and 5-FU 600 mg/m2/day IV over 22 hours. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.

Drug: Pegilodecakin; Drug: FOLFOX (Oxaliplatin/Leucovorin/5-Fluorouracil)

Part D: Pegilodecakin 0.4/ 0.5 mg + Gemcitabine/Nab-Paclitaxel

EXPERIMENTAL

Participants received 0.4 or 0.5 mg of Pegilodecakin QD administered SC with Gemcitabine 1000 mg/m2 IV over 30 minutes plus nab-paclitaxel 125 mg/m2 IV over 30 to 40 minutes on Days 1, 8, and 15 of every 28-day cycle. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.

Drug: Pegilodecakin; Drug: gemcitabine/nab-paclitaxel

Part E: Pegilodecakin 0.8/1 mg + Capecitabine

EXPERIMENTAL

Participants received 0.8 or 1 mg of Pegilodecakin QD administered SC with Capecitabine 1000 mg/m² orally twice daily (BID) on Days 1 through 14 of each 21-day cycle. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.

Drug: Pegilodecakin; Drug: Capecitabine

Part F: Pegilodecakin 0.8/ 1 mg + Paclitaxel

EXPERIMENTAL

Participants received 0.8 or 1 mg of Pegilodecakin QD administered SC with Paclitaxel 80 mg/m2 IV over 3 hours on Days 1, 8, and 15 of every 28-day cycle. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.

Drug: Pegilodecakin; Drug: Paclitaxel

Part G: Pegilodecakin 0.8/1 mg + Pazopanib

EXPERIMENTAL

Participants received a 0.8 or 1 mg of Pegilodecakin QD administered SC with Pazopanib 800 mg orally QD. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.

Drug: Pegilodecakin; Drug: Pazopanib

Part H: Pegilodecakin 0.8/1 mg + Pembrolizumab

EXPERIMENTAL

Participants received 0.8 or 1 mg of Pegilodecakin QD administered SC with Pembrolizumab 2 mg/kg bolus IV infusion over 30 minutes on Day 1 of each 21-day cycle. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.

Drug: Pegilodecakin; Drug: Pembrolizumab

Part H: Pegilodecakin 1.6/2 mg + Pembrolizumab

EXPERIMENTAL

Participants received 1.6 or 2 mg of Pegilodecakin QD administered SC with Pembrolizumab 2 mg/kg bolus IV infusion over 30 minutes on Day 1 of each 21-day cycle. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.

Drug: Pegilodecakin; Drug: Pembrolizumab

Part H: Pegilodecakin 3.2/4 mg + Pembrolizumab

EXPERIMENTAL

Participants received 3.2 or 4 mg of Pegilodecakin QD administered SC with Pembrolizumab 2 mg/kg bolus IV infusion over 30 minutes on Day 1 of each 21-day cycle. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.

Drug: Pegilodecakin; Drug: Pembrolizumab

Part J: Pegilodecakin 0.8/1 mg + Gemcitabine/Carboplatin

EXPERIMENTAL

Participants received 0.8 or 1 mg of Pegilodecakin QD administered SC with gemcitabine 500 mg/m2 IV over 30 minutes followed by carboplatin targeting an Area Under the Curve of 2 mg/mL x min (AUC2) IV over 60 minutes on Days 1 and 8 of each 21-day cycle. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.

Drug: Pegilodecakin; Drug: Gemcitabine/carboplatin

Part I: Pegilodecakin 1.6/2 mg + Nivolumab

EXPERIMENTAL

Participants received 1.6 or 2 mg of Pegilodecakin QD administered SC with Nivolumab 3 mg/kg IV infusion over 60 minutes on Day 1 of each 14-day cycle. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.

Drug: Pegilodecakin; Drug: nivolumab

Part I: Pegilodecakin 0.8/1 mg + Nivolumab

EXPERIMENTAL

Participants received 0.8 or 1 mg of Pegilodecakin QD administered SC with Nivolumab 3 mg/kg IV infusion over 60 minutes on Day 1 of each 14-day cycle. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.

Drug: Pegilodecakin; Drug: nivolumab

Part J: Pegilodecakin 0.4/0.5 mg + Gemcitabine/Carboplatin

EXPERIMENTAL

Participants received 0.4 or 0.5 mg of Pegilodecakin QD administered SC with gemcitabine 500 mg/m2 IV over 30 minutes followed by carboplatin targeting an AUC2 IV over 60 minutes on Days 1 and 8 of each 21-day cycle. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.

Drug: Pegilodecakin; Drug: Gemcitabine/carboplatin

Interventions

Pegilodecakin DRUG

Daily subcutaneous injections of pegilodecakin up to 12 months

Also known as: LY3500518, AM0010, PEGylated recombinant human Interleukin-10, PEG-rHuIL-10

Part A: Pegilodecakin 0.08/0.1 mg; Part A: Pegilodecakin 0.2/0.25 mg; Part A: Pegilodecakin 0.4/0.5 mg; Part A: Pegilodecakin 0.8/1 mg; Part A: Pegilodecakin 1.6/2 mg; Part A: Pegilodecakin 3.2/4 mg; Part B: Pegilodecakin 0.2/0.25 mg + Platinum/Taxane; Part B: Pegilodecakin 0.4/0.5 mg + Platinum/Taxane; Part B: Pegilodecakin 0.8/1 mg + Platinum/Taxane; Part C: Pegilodecakin 0.2/0.25 mg + FOLFOX; Part C: Pegilodecakin 0.4/0.5 mg + FOLFOX; Part C: Pegilodecakin 0.8/1 mg + FOLFOX; Part D: Pegilodecakin 0.4/ 0.5 mg + Gemcitabine/Nab-Paclitaxel; Part E: Pegilodecakin 0.8/1 mg + Capecitabine; Part F: Pegilodecakin 0.8/ 1 mg + Paclitaxel; Part G: Pegilodecakin 0.8/1 mg + Pazopanib; Part H: Pegilodecakin 0.8/1 mg + Pembrolizumab; Part H: Pegilodecakin 1.6/2 mg + Pembrolizumab; Part H: Pegilodecakin 3.2/4 mg + Pembrolizumab; Part I: Pegilodecakin 0.8/1 mg + Nivolumab; Part I: Pegilodecakin 1.6/2 mg + Nivolumab; Part J: Pegilodecakin 0.4/0.5 mg + Gemcitabine/Carboplatin; Part J: Pegilodecakin 0.8/1 mg + Gemcitabine/Carboplatin

Paclitaxel or Docetaxel and Carboplatin or Cisplatin DRUG

Platinum/ Taxane administered IV on Day 1 of every 21 day cycle

Also known as: Taxol or taxotere and paraplatin or platinol

Part B: Pegilodecakin 0.2/0.25 mg + Platinum/Taxane; Part B: Pegilodecakin 0.4/0.5 mg + Platinum/Taxane; Part B: Pegilodecakin 0.8/1 mg + Platinum/Taxane

FOLFOX (Oxaliplatin/Leucovorin/5-Fluorouracil) DRUG

FOLFOX administered IV on Day 1 and 2 of every 14 day cycle

Also known as: Eloxatin®/Leucovorin/5-FU

Part C: Pegilodecakin 0.2/0.25 mg + FOLFOX; Part C: Pegilodecakin 0.4/0.5 mg + FOLFOX; Part C: Pegilodecakin 0.8/1 mg + FOLFOX

gemcitabine/nab-paclitaxel DRUG

Gemcitabine/nab-paclitaxel administered IV on Day 1, 8 and 15 of each 28 day treatment cycle.

Also known as: Gemzar/Abraxane ABI-007

Part D: Pegilodecakin 0.4/ 0.5 mg + Gemcitabine/Nab-Paclitaxel

Pazopanib DRUG

Pazopanib administered orally daily continuously

Also known as: GW786034

Part G: Pegilodecakin 0.8/1 mg + Pazopanib

Capecitabine DRUG

Capecitabine administered orally twice daily for 14 days out of every 21 days.

Also known as: Xeloda

Part E: Pegilodecakin 0.8/1 mg + Capecitabine

Pembrolizumab DRUG

Pembrolizumab administered IV on Day 1 of every 21 day cycle.

Also known as: Keytruda, MK-3475

Part H: Pegilodecakin 0.8/1 mg + Pembrolizumab; Part H: Pegilodecakin 1.6/2 mg + Pembrolizumab; Part H: Pegilodecakin 3.2/4 mg + Pembrolizumab

Paclitaxel DRUG

Paclitaxel administered IV on Days 1, 8, 15 of each cycle (28 days= 1 cycle)

Part F: Pegilodecakin 0.8/ 1 mg + Paclitaxel

nivolumab DRUG

Nivolumab administered IV on Day 1 of each cycle (14 days = 1 cycle)

Also known as: Opdivo

Part I: Pegilodecakin 0.8/1 mg + Nivolumab; Part I: Pegilodecakin 1.6/2 mg + Nivolumab

Gemcitabine/carboplatin DRUG

Gemcitabine and carboplatin administered IV on Days 1, 8 of each cycle (21 days = 1 cycle)

Also known as: gemzar/paraplatin

Part J: Pegilodecakin 0.4/0.5 mg + Gemcitabine/Carboplatin; Part J: Pegilodecakin 0.8/1 mg + Gemcitabine/Carboplatin

Eligibility Criteria

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

You may qualify if:

• Part A Escalation Cohorts:
• o Histologically or cytologically confirmed advanced malignant solid tumor, limited to melanoma, castrate resistant prostate cancer (CRPC), ovarian cancer (OVCA), renal cell carcinoma, colorectal carcinoma (CRC), pancreatic carcinoma or non-small cell lung carcinoma (NSCLC) that is refractory to, intolerant of, for which no standard of therapy is available or where the participant refuses existing therapies
• Part A Expansion Cohorts, Part B and C Escalation and Expansion Cohorts:
• Tumors with all histological diagnosis or tissue origin may be enrolled
• Participants must have failed prior standard curative chemotherapy for their disease, refuse existing therapies OR the proposed chemotherapy regimen to which pegilodecakin is added represents an acceptable standard treatment for their disease.
• Measurable or evaluable disease according to irRC or bone metastatic disease evaluable by Prostate Cancer Working Group 2 criteria (PCWG2) for castration-resistant prostate cancer (CRPC)
• At least 18 years of age
• Performance Status of 0 or 1
• Adequate organ function

You may not qualify if:

• Hematologic malignancies
• Pregnant or lactating
• Present or history of neurological disorders such as Multiple Sclerosis and Guillain Barre or inflammatory central nervous system/peripheral nervous system (CNS/PNS) disorders
• Myocardial infarction within the last 6 months
• Unstable angina, or unstable cardiac arrhythmia requiring medication
• Surgery within the last 28 days
• Systemic fungal, bacterial, viral, or other infection
• History of bleeding diathesis within the last 6 months
• Positive for human immunodeficiency virus (HIV), hepatitis C, or hepatitis B

Sponsors & Collaborators

• Eli Lilly and Company: lead
• ARMO BioSciences: collaborator

Study Sites (10)

UCLA Medical Hematology & Oncology

Los Angeles, California, 90024, United States

Location

UCSF

San Francisco, California, United States

Location

Sarah Cannon Research Institute at HealthONE

Denver, Colorado, 80218, United States

Location

Florida Cancer Specialists & Research Institute

Sarasota, Florida, 34232, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Stephenson Cancer Center at Oklahoma University TSET Phase 1 Program

Oklahoma City, Oklahoma, 73104, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

The University of Texas M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

South Texas Accelerated Research Therapeutics

San Antonio, Texas, 78229, United States

Location

Related Publications (2)

• Naing A, Wong DJ, Infante JR, Korn WM, Aljumaily R, Papadopoulos KP, Autio KA, Pant S, Bauer TM, Drakaki A, Daver NG, Hung A, Ratti N, McCauley S, Van Vlasselaer P, Verma R, Ferry D, Oft M, Diab A, Garon EB, Tannir NM. Pegilodecakin combined with pembrolizumab or nivolumab for patients with advanced solid tumours (IVY): a multicentre, multicohort, open-label, phase 1b trial. Lancet Oncol. 2019 Nov;20(11):1544-1555. doi: 10.1016/S1470-2045(19)30514-5. Epub 2019 Sep 25.

  PMID: 31563517 DERIVED

• Naing A, Papadopoulos KP, Autio KA, Ott PA, Patel MR, Wong DJ, Falchook GS, Pant S, Whiteside M, Rasco DR, Mumm JB, Chan IH, Bendell JC, Bauer TM, Colen RR, Hong DS, Van Vlasselaer P, Tannir NM, Oft M, Infante JR. Safety, Antitumor Activity, and Immune Activation of Pegylated Recombinant Human Interleukin-10 (AM0010) in Patients With Advanced Solid Tumors. J Clin Oncol. 2016 Oct 10;34(29):3562-3569. doi: 10.1200/JCO.2016.68.1106.

  PMID: 27528724 DERIVED

MeSH Terms

Conditions

Melanoma; Prostatic Neoplasms; Ovarian Neoplasms; Carcinoma, Renal Cell; Colorectal Neoplasms; Pancreatic Neoplasms; Carcinoma, Non-Small-Cell Lung; Breast Neoplasms; Neoplasms

Interventions

pegilodecakin; AM0010; Paclitaxel; Docetaxel; Carboplatin; Cisplatin; Folfox protocol; Oxaliplatin; Gemcitabine; Capecitabine; pazopanib; pembrolizumab; Nivolumab

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Neoplasms, Female; Endocrine System Diseases; Gonadal Disorders; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Urologic Neoplasms; Kidney Diseases; Urologic Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Pancreatic Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Breast Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2013
• First Posted: December 12, 2013
• Study Start: November 15, 2013
• Primary Completion: February 19, 2019
• Study Completion: July 22, 2023
• Last Updated: July 9, 2026
• Results First Posted: July 9, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)