Dose Escalation and Double-blind Study of Veliparib in Combination With Carboplatin and Etoposide in Treatment-naive Extensive Stage Disease Small Cell Lung Cancer

NCT02289690 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: M14-3612014-001764-35
• Study Type: interventional
• Target: 221
• Locations: 12 countries
• Sites: 62

Brief Summary

The study seeks to assess the efficacy of veliparib (ABT-888) in combination with carboplatin and etoposide in participants with extensive disease small cell lung cancer (ED SCLC).

Conditions

Small Cell Lung Cancer

Keywords

Extensive Stage Smal Cell Lung Cancer; ABT-888; Veliparib; PARP - Poly (ADP) ribose polymerase

Outcome Measures

Primary Outcomes (17)

• Phase 1: Number of Participants With Dose-limiting Toxicities (DLTs)

  A DLT was defined as any of the following drug-related toxicities, graded according to the Common Toxicity Criteria for Adverse Events (CTCAE), V.4.0: 1. Events associated with treatment delay \>14 days in initiating Cycle 2 therapy: Grade 4 thrombocytopenia, neutropenia, or febrile neutropenia, or Grade 3 febrile neutropenia with fever for \> 7 days 2. Grade ≥ 3 non-hematologic toxicity with ≥ 2 grade increase from baseline and attributed to veliparib treatment, excluding nausea or vomiting for ≤ 48 hours or inadequately treated, electrolyte abnormalities resolving in ≤ 24 hours, hypersensitivity reactions or alopecia 3. Grade 2 non-hematologic toxicity of ≥ 2 grade increase from baseline, attributed to veliparib treatment requiring delay of \>14 days in initiation of Cycle 2 4. Any toxicity of ≥ 2-grade increase from baseline, attributed to veliparib and requiring a dose modification in Cycle 1 or omission of carboplatin, \>1 daily etoposide dose, or \>30% veliparib doses in Cycle 1

  Cycle 1 Day -2 to pre-dose on Cycle 2 Day 1 (23 days)

• Phase 1: Maximum Observed Plasma Concentration (Cmax) of Veliparib

  Plasma concentrations of veliparib were determined using a validated online solid-phase extraction followed by high-performance liquid chromatography with tandem mass spectrometric detection (HPLC LC-MS/MS). The lower limit of quantitation (LLOQ) for veliparib was established at ≥ 1.05 ng/mL.

  Cycle 1 Day 1 predose and at 1, 2, 3, 5, 8, and 24 hours post-dose

• Phase 1: Time to Maximum Observed Plasma Concentration (Tmax) of Veliparib

  Plasma concentrations of veliparib were determined using a validated online solid-phase extraction followed by high-performance liquid chromatography with tandem mass spectrometric detection (HPLC LC-MS/MS). The lower limit of quantitation (LLOQ) for veliparib was established at ≥ 1.05 ng/mL.

  Cycle 1 Day 1 predose and at 1, 2, 3, 5, 8, and 24 hours post-dose

• Phase 1: Area Under the Plasma Concentration-time Curve From Time 0 to 8 Hours Post-dose (AUC[0-8]) of Veliparib

  The area under the plasma concentration-time curve from time 0 to 8 hours post-dose for veliparib was estimated using non-compartmental methods.

  Cycle 1 Day 1 predose and at 1, 2, 3, 5, 8, and 24 hours post-dose

• Phase 1: Area Under the Plasma Concentration-time Curve From Time 0 to 12 Hours Post-dose (AUC[0-12]) of Veliparib

  The area under the plasma concentration-time curve from time 0 to 12 hours post-dose for veliparib was estimated using non-compartmental methods. AUC(0-12) was calculated by assuming the concentration at 12 hours post-dose was the same as the pre-dose concentration.

  Cycle 1 Day 1 predose and at 1, 2, 3, 5, 8, and 24 hours post-dose

• Phase 1: Dose-normalized Maximum Observed Plasma Concentration of Veliparib

  Plasma concentrations of veliparib were determined using a validated online solid-phase extraction followed by high-performance liquid chromatography with tandem mass spectrometric detection (HPLC LC-MS/MS). The lower limit of quantitation (LLOQ) for veliparib was established at ≥ 1.05 ng/mL. Dose normalized Cmax is calculated as Cmax / veliparib dose in mg.

  Cycle 1 Day 1 predose and at 1, 2, 3, 5, 8, and 24 hours post-dose

• Phase 1: Dose-normalized Area Under the Plasma Concentration-time Curve From Time 0 to 8 Hours Post-dose of Veliparib

  The area under the plasma concentration-time curve from time 0 to 8 hours post-dose for veliparib was estimated using non-compartmental methods. Dose normalized AUC(0-8) is calculated as AUC(0-8) / veliparib dose in mg.

  Cycle 1 Day 1 predose and at 1, 2, 3, 5, 8, and 24 hours post-dose

• Phase 1: Dose-normalized Area Under the Plasma Concentration-time Curve From Time 0 to 12 Hours Post-dose of Veliparib

  The area under the plasma concentration-time curve from time 0 to 12 hours post-dose for veliparib was estimated using non-compartmental methods. AUC(0-12) was calculated by assuming the concentration at 12 hours post-dose was the same as the pre-dose concentration. Dose normalized AUC(0-12) is calculated as AUC(0-12) / veliparib dose in mg.

  Cycle 1 Day 1 predose and at 1, 2, 3, 5, 8, and 24 hours post-dose

• Phase 1: Maximum Observed Plasma Concentration (Cmax) of Etoposide With and Without Veliparib

  Etoposide plasma concentrations were determined using liquid chromatography with tandem mass spectrometric detection with a lower limit of quantitation 160 ng/mL.

  Cycle 1 Day 1 (coadministered with veliparib and carboplatin), and on Cycle 2 Day 1 (co-administered with carboplatin but in the absence of veliparib) at 55 minutes (5 minutes before the end of infusion) and 3, 5, 8, and 24 hours post-dose.

• Phase 1: Time to Maximum Observed Plasma Concentration (Tmax) of Etoposide With and Without Veliparib

  Etoposide plasma concentrations were determined using liquid chromatography with tandem mass spectrometric detection with a lower limit of quantitation 160 ng/mL.

  Cycle 1 Day 1 (coadministered with veliparib and carboplatin), and on Cycle 2 Day 1 (co-administered with carboplatin but in the absence of veliparib) at 55 minutes (5 minutes before the end of infusion) and 3, 5, 8, and 24 hours post-dose.

• Phase 1: Area Under the Concentration-time Curve From Time 0 to Time of Last Measurable Concentration (AUC[0-t]) of Etoposide With and Without Veliparib

  The area under the plasma concentration-time curve from 0 to the last measurable concentration (24 hours) of etoposide was estimated using using non-compartmental methods.

  Cycle 1 Day 1 (coadministered with veliparib and carboplatin), and on Cycle 2 Day 1 (co-administered with carboplatin but in the absence of veliparib) at 55 minutes (5 minutes before the end of infusion) and 3, 5, 8, and 24 hours post-dose.

• Phase 1: Area Under the Concentration-time Curve From Time 0 to Infinity (AUC[0-∞]) of Etoposide With and Without Veliparib

  The area under the plasma concentration-time curve from 0 to infinity for etoposide was estimated using using non-compartmental methods.

  Cycle 1 Day 1 (coadministered with veliparib and carboplatin), and on Cycle 2 Day 1 (co-administered with carboplatin but in the absence of veliparib) at 55 minutes (5 minutes before the end of infusion) and 3, 5, 8, and 24 hours post-dose.

• Phase 1: Terminal Phase Elimination Half-life (t1/2) of Etoposide With and Without Veliparib

  The terminal half-life of etoposide was estimated using using non-compartmental methods. Values reported represent the harmonic mean ± pseudo-standard deviation.

  Cycle 1 Day 1 (coadministered with veliparib and carboplatin), and on Cycle 2 Day 1 (co-administered with carboplatin but in the absence of veliparib) at 55 minutes (5 minutes before the end of infusion) and 3, 5, 8, and 24 hours post-dose.

• Phase 1: Dose-normalized Maximum Observed Plasma Concentration (Cmax) of Etoposide With and Without Veliparib

  Etoposide plasma concentrations were determined using liquid chromatography with tandem mass spectrometric detection with a lower limit of quantitation 160 ng/mL. Dose normalized Cmax is calculated as Cmax / etoposide dose in mg/m².

  Cycle 1 Day 1 (coadministered with veliparib and carboplatin), and on Cycle 2 Day 1 (co-administered with carboplatin but in the absence of veliparib) at 55 minutes (5 minutes before the end of infusion) and 3, 5, 8, and 24 hours post-dose.

• Phase 1: Dose-normalized Area Under the Concentration-time Curve From Time 0 to Time of Last Measurable Concentration (AUC[0-t]) of Etoposide With and Without Veliparib

  The area under the plasma concentration-time curve from 0 to the last measurable concentration (24 hours) of etoposide was estimated using using non-compartmental methods. Dose normalized AUC(0-t) is calculated as AUC(0-t) / etoposide dose in mg/m².

  Cycle 1 Day 1 (coadministered with veliparib and carboplatin), and on Cycle 2 Day 1 (co-administered with carboplatin but in the absence of veliparib) at 55 minutes (5 minutes before the end of infusion) and 3, 5, 8, and 24 hours post-dose.

• Phase 1: Dose-normalized Area Under the Concentration-time Curve From Time 0 to Infinity (AUC[0-∞]) of Etoposide With and Without Veliparib

  The area under the plasma concentration-time curve from 0 to infinity for etoposide was estimated using using non-compartmental methods. Dose normalized AUC(0-∞) is calculated as AUC(0-∞) / etoposide dose in mg/m².

  Cycle 1 Day 1 (coadministered with veliparib and carboplatin), and on Cycle 2 Day 1 (co-administered with carboplatin but in the absence of veliparib) at 55 minutes (5 minutes before the end of infusion) and 3, 5, 8, and 24 hours post-dose.

• Phase 2: Progression-free Survival

  Progression-free survival (PFS) is defined as the time from the date of randomization to the date of earliest radiographic disease progression or death provided no radiographic disease progression occurred. If a participant did not have an event of disease progression and had not died on or prior to the cutoff for PFS analysis, the participant's data was censored at the date of their last disease assessment or randomization date provided participant did not have any post-baseline disease assessment. Disease assessments were performed using computed tomography according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. Progressive Disease (PD) was defined as at least a 20% increase in the size of target lesions and an absolute increase of at least 5 mm taking as reference the smallest lesion size recorded since the treatment started (baseline or after), or the appearance of one or more new lesions.

  From randomization up to the date the 126th PFS event was reached; Median time on follow-up was 7.3, 7.1, and 8.9 months in each treatment group respectively.

Secondary Outcomes (3)

• Phase 2: Overall Survival

  From randomization until the end of study; median time on follow-up was 10.0, 8.6, and 11.7 months in each treatment group respectively.

• Phase 2: Objective Response Rate

  Tumor assessments were performed every 6 weeks for the first 30 weeks and every 9 weeks thereafter until disease progression; median time on follow-up was 7.3, 7.1, and 8.9 months in each group respectively.

• Phase 1: Number of Participants With Adverse Events

  From first dose of any study drug to 30 days after the last dose; the median duration of treatment with veliparib across all groups in Phase 1 was 127.5 days.

Study Arms (4)

Phase 1: Veliparib + Carboplatin + Etoposide

EXPERIMENTAL

Participants in Phase 1 will be sequentially assigned to ascending dose levels of veliparib in combination with carboplatin/etoposide for up to four 21-day cycles. Participants without evidence of disease progression will continue on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.

Drug: Veliparib; Drug: Carboplatin; Drug: Etoposide

Phase 2: Veliparib + Carboplatin + Etoposide -> Veliparib

EXPERIMENTAL

Participants will receive veliparib 240 mg in combination with carboplatin/etoposide for four to six 21-day cycles followed by veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.

Drug: Veliparib; Drug: Carboplatin; Drug: Etoposide

Phase 2: Veliparib + Carboplatin + Etoposide -> Placebo

EXPERIMENTAL

Participants will receive veliparib 240 mg in combination with carboplatin/etoposide for four to six 21-day cycles followed by placebo monotherapy continuous dosing (21-day cycles) until disease progression or unacceptable toxicity occurs.

Drug: Veliparib; Drug: Carboplatin; Drug: Etoposide; Drug: Placebo

Phase 2: Placebo + Carboplatin + Etoposide -> Placebo

ACTIVE COMPARATOR

Participants will receive placebo in combination with carboplatin/etoposide for four to six 21-day cycles followed by placebo monotherapy continuous dosing (21-day cycles) until disease progression or unacceptable toxicity occurs.

Drug: Carboplatin; Drug: Etoposide; Drug: Placebo

Interventions

Veliparib DRUG

Capsules administered orally twice a day according to the dosing schedule.

Also known as: ABT-888

Phase 1: Veliparib + Carboplatin + Etoposide; Phase 2: Veliparib + Carboplatin + Etoposide -> Placebo; Phase 2: Veliparib + Carboplatin + Etoposide -> Veliparib

Carboplatin DRUG

Administered by intravenous infusion on Day 1 of each 21-day cycle over approximately 30 minutes at a target area under the curve (AUC) 5 mg/mL\*minute.

Phase 1: Veliparib + Carboplatin + Etoposide; Phase 2: Placebo + Carboplatin + Etoposide -> Placebo; Phase 2: Veliparib + Carboplatin + Etoposide -> Placebo; Phase 2: Veliparib + Carboplatin + Etoposide -> Veliparib

Etoposide DRUG

Administered by intravenous infusion on Days 1 to 3 of every 21-day cycle over approximately 60 minutes at 100 mg/m².

Also known as: VP-16

Phase 1: Veliparib + Carboplatin + Etoposide; Phase 2: Placebo + Carboplatin + Etoposide -> Placebo; Phase 2: Veliparib + Carboplatin + Etoposide -> Placebo; Phase 2: Veliparib + Carboplatin + Etoposide -> Veliparib

Placebo DRUG

Placebo to veliparib administered orally twice a day according to the dosing schedule.

Phase 2: Placebo + Carboplatin + Etoposide -> Placebo; Phase 2: Veliparib + Carboplatin + Etoposide -> Placebo

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject with histologically or cytologically confirmed extensive-stage disease SCLC which is newly diagnosed and chemotherapy naive
• Phase 1 ONLY: histologically or cytologically confirmed advanced/metastatic solid tumors for which carboplatin/etoposide treatment is considered appropriate.
• Subject in Phase 2 only: must have measurable disease per RECIST 1.1.
• Subjects with ED SCLC must consent to provide available archived formalin fixed paraffin embedded (FFPE) tissue sample of SCLC lesion (primary or metastatic) for central review and biomarker analysis.
• Subject has an Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 1.
• Subject must have adequate hematologic, renal and hepatic function.

You may not qualify if:

• Phase 1 ONLY: Subject has had any prior anti-cancer therapy other than:
• Hormonal, non-myelosuppressive, biologic, targeted, or immune therapy (must be completed ≥ 4 weeks prior to Cycle 1 Day -2).
• One line of cytotoxic chemotherapy (must be completed ≥ 4 weeks prior to Cycle 1 Day -2).
• Adjuvant/neoadjuvant radiotherapy (must be completed ≥ 12 months prior to Cycle 1 Day -2, with field not involving \> 10% of bone marrow reserve).
• Phase 2 ONLY: Subject has had any prior chemotherapy, radiotherapy, investigational anti-cancer agents or biologic therapy for the disease under study. Single non-target lesion irradiation with intent of symptom palliation is allowed if ≥ 4 weeks prior Cycle 1 Day -2.
• Subject has current central nervous system (CNS) or leptomeningeal metastases or history of CNS or leptomeningeal metastases.
• Subject has a history of seizures within 12 months of Cycle 1 Day-2 or diagnosed neurological condition placing subject at the increased risk of seizures.
• Subject has received anti-cancer Chinese medicine or anti-cancer herbal remedies within 14 days prior to Cycle 1 Day-2.
• Subject has had major surgery within 6 weeks prior to Cycle 1 Day-2 (subjects must have completely recovered from any previous surgery prior Cycle 1 Day-2).
• Subject has clinically significant and uncontrolled major medical condition(s) including but not limited to:
• Uncontrolled nausea/vomiting/diarrhea;
• Active uncontrolled infection;
• History of hepatitis B (HBV) with surface antigen (HBsAg) positivity within 3 months prior to the date of informed consent for this study (if no test has been performed within 3 months, it must be done at screening);
• History of hepatitis C (HCV) with HCV ribonucleic acid (RNA) positivity within 3 months prior to the date of informed consent for this study (if no test has been performed within 3 months it must be done at screening);
• Symptomatic congestive heart failure (Yew York Heart Association \[NYHA\] class ≥ II);

Sponsors & Collaborators

• AbbVie: lead

Study Sites (62)

Mayo Clinic - Scottsdale /ID# 129127

Scottsdale, Arizona, 85259, United States

Location

Univ of Colorado Cancer Center /ID# 129220

Aurora, Colorado, 80045, United States

Location

Emory University Hospital /ID# 141682

Atlanta, Georgia, 30322, United States

Location

Georgia Regents University /ID# 148567

Augusta, Georgia, 30912, United States

Location

Northwestern University Feinberg School of Medicine /ID# 137088

Chicago, Illinois, 60611-2927, United States

Location

Herbert Herman Cancer Center /ID# 167020

Lansing, Michigan, 48912, United States

Location

Gabrail Cancer Center Research /ID# 129216

Canton, Ohio, 44718, United States

Location

Allegheny General Hospital /ID# 147328

Pittsburgh, Pennsylvania, 15212, United States

Location

University of Texas MD Anderson Cancer Center /ID# 129213

Houston, Texas, 77030, United States

Location

Southern Medical Day Care Ctr /ID# 155498

Wollongong, New South Wales, 2500, Australia

Location

The Townsville Hospital /ID# 155499

Douglas, Queensland, 4814, Australia

Location

Peninsula & South Eastern Haem /ID# 155497

Frankston, Victoria, 3199, Australia

Location

Border Medical /ID# 157894

Wodonga, Victoria, 3690, Australia

Location

Cliniques Universitaires Saint Luc /ID# 151024

Woluwe-Saint-Lambert, Brussels Capital, 1200, Belgium

Location

CHU de Liege /ID# 151025

Liège, Liege, 4000, Belgium

Location

UZ Antwerp /ID# 151026

Edegem, 2650, Belgium

Location

C.H.U.de Mons Borinage /ID# 151023

Mons, 7000, Belgium

Location

CHU UCL Namur /ID# 151022

Namur, 5000, Belgium

Location

University of Calgary /ID# 152544

Calgary, Alberta, T2N 4Z6, Canada

Location

Cross Cancer Institute /ID# 132883

Edmonton, Alberta, T6G 1Z2, Canada

Location

Juravinski Cancer Clinic /ID# 152543

Hamilton, Ontario, L8V 1C3, Canada

Location

Hopital du Sacre Coeur Montreal /ID# 154436

Montreal, Quebec, H4J 1C5, Canada

Location

Nemocnice Na Plesi s.r.o. /ID# 149825

Nová Ves pod Pleší, Pribram, 262 04, Czechia

Location

Nemocnice Novy Jicin /ID# 149838

Nový Jičín, 741 01, Czechia

Location

Vitkovicka nemocnice a. s. /ID# 149839

Ostrava, 703 84, Czechia

Location

Multiscan s.r.o. /ID# 150887

Pardubice, 530-03, Czechia

Location

CHU Dupuytren /ID# 153622

Limoges, Franche-Comte, 87042, France

Location

Centre Hospitalier Le Mans /ID# 158103

Le Mans, Sarthe, 72037, France

Location

Centre Hosp Intercommunal de Creteil /ID# 157970

Créteil, Val-de-Marne, 94000, France

Location

Orszagos Koranyi Pulmonologiai Intezet /ID# 151351

Budapest XII, Budapest, 1122, Hungary

Location

Markusovszky Egyetemi Oktatókórház /ID# 158806

Szombathely, Vas County, 9700, Hungary

Location

Debreceni Egyetem Klinikai Központ /ID# 151354

Debrecen, 4032, Hungary

Location

Veszprem Megyei Tudogyogyintez /ID# 158807

Farkasgyepű, 8582, Hungary

Location

Petz Aladar Megyei Oktato Korh /ID# 155352

Győr, 9023, Hungary

Location

Matrahaza Gyogyintezet /ID# 151355

Kékesteto, 3233, Hungary

Location

Fejer Megyei Szent Gyorgy Korh /ID# 151352

Székesfehérvár, 8000, Hungary

Location

Jasz-Nagykun-Szolnok Megyei /ID# 155090

Szolnok, 5004, Hungary

Location

Universitair Medisch Centrum Groningen /ID# 131252

Groningen, 9713 GZ, Netherlands

Location

Ziekenhuis St. Jansdal /ID# 151974

Harderwijk, 3844 DG, Netherlands

Location

Atrium-Orbis Zuyderland Medisch Centrum /ID# 149830

Heerlen, 6419 PC, Netherlands

Location

Erasmus Medisch Centrum /ID# 131251

Rotterdam, 3015 CE, Netherlands

Location

Isala /ID# 151975

Zwolle, 8025 AB, Netherlands

Location

S.C. Centrul de Oncologie Sf. Nectarie S.R.L. /ID# 161137

Craiova, Dolj, 200347, Romania

Location

Oncocenter Oncologie Clinica S /ID# 151694

Timișoara, Timiș County, 300166, Romania

Location

S.C. Radiotherapy Center Cluj /ID# 165137

Cluj-Napoca, 407280, Romania

Location

NN Blokhin Russian Cancer /ID# 152329

Moscow, Moscow, 115478, Russia

Location

Sverdlovsk Regional Oncology Center Dispensary /ID# 152328

Yekaterinburg, Sverdlovsk Oblast, 620043, Russia

Location

Belgorod Oncology Dispensary /ID# 152330

Belgorod, 308001, Russia

Location

Univercity Headache Clynic,LTD /ID# 161708

Moscow, 109028, Russia

Location

Murmansk RCH P.A. Bayandina /ID# 152331

Murmansk, 183047, Russia

Location

Road Hospital Open Joint Stock Company Russian Railways /ID# 152731

Saint Petersburg, 195271, Russia

Location

Ogarev Mordovia State Univ /ID# 152327

Saransk, 430005, Russia

Location

Dong-A University Hospital /ID# 153187

Busan, Busan Gwang Yeogsi, 49201, South Korea

Location

Chungbuk National Univ Hosp /ID# 153186

Cheongju-si, 361-240, South Korea

Location

Chonnam National University Hwasun Hospital /ID# 153188

Jeonnam, 58128, South Korea

Location

Asan Medical Center /ID# 153185

Seoul, 05505, South Korea

Location

Hospital Stanta Creu i Sant Pau /ID# 151254

Barcelona, 08025, Spain

Location

Hosp Univ Quiron Dexues /ID# 130302

Barcelona, 08028, Spain

Location

Hospital Universitario Gregori /ID# 164982

Madrid, 28009, Spain

Location

Hosp Univ 12 de Octubre /ID# 151252

Madrid, 28041, Spain

Location

Hosp Univ Madrid Sanchinarro /ID# 130301

Madrid, 28050, Spain

Location

Hosp Univ Puerta de Hierro Maj /ID# 151253

Majadahonda, 28222, Spain

Location

Related Publications (1)

• Atrafi F, Groen HJM, Byers LA, Garralda E, Lolkema MP, Sangha RS, Viteri S, Chae YK, Camidge DR, Gabrail NY, Hu B, Tian T, Nuthalapati S, Hoening E, He L, Komarnitsky P, Calles A. A Phase I Dose-Escalation Study of Veliparib Combined with Carboplatin and Etoposide in Patients with Extensive-Stage Small Cell Lung Cancer and Other Solid Tumors. Clin Cancer Res. 2019 Jan 15;25(2):496-505. doi: 10.1158/1078-0432.CCR-18-2014. Epub 2018 Oct 16.

  PMID: 30327308 RESULT

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

veliparib; Carboplatin; Etoposide

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

800-633-9110

Study Officials

• AbbVie Inc.

  AbbVie

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Phase 1 was open-label, phase 2 was conducted in a double-blind manner.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: November 10, 2014
• First Posted: November 13, 2014
• Study Start: October 13, 2014
• Primary Completion: April 17, 2019
• Study Completion: April 17, 2019
• Last Updated: May 14, 2020
• Results First Posted: May 14, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
• Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.

Locations

AU (4); BE (5); US (9); CZ (4); FR (3); RO (3); RU (7); KR (4); ES (6); HU (8); NL (5); CA (4)