Efficacy and Safety of Aldoxorubicin Compared to Topotecan in Subjects With Metastatic Small Cell Lung Cancer

NCT02200757 | Completed Phase 2 Results DMC

• 1 other identifier: ALDOXORUBICIN-P2-SCLC-01
• Study Type: interventional
• Target: 135
• Locations: 3 countries
• Sites: 29

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of aldoxorubicin compared to topotecan in subjects with metastatic small cell lung cancer.

Conditions

Metastatic Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS)

  PFS is defined as the time from the date of randomization to first documentation of objective tumor progression or to death due to any cause in the absence of previous documentation of objective tumor progression. Progressive Disease is defined as: ≥20% increase in the sum of the longest diameter of target lesions from the smallest sum of the longest diameter recorded since the treatment started; the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of ≥1 new lesion is also considered progression.

  24 months

Secondary Outcomes (1)

• Number of Participants With Treatment-related Toxicities (Adverse Events)

  Treatment was planned to continue until tumor progression is observed, subject asks to withdraw, or unacceptable toxicity occurs, up to 451 days.

Study Arms (2)

Aldoxorubicin

EXPERIMENTAL

Drug: Aldoxorubicin

Topotecan

ACTIVE COMPARATOR

Drug: Topotecan

Interventions

Aldoxorubicin DRUG

230 mg/m2 (170 mg/m2 doxorubicin equivalent) intravenously on Day 1 of each 21-day cycle. Number of cycles: until tumor progression or unacceptable toxicity occurs.

Also known as: INNO-206

Aldoxorubicin

Topotecan DRUG

1.5 mg/m2/day intravenously for 5 consecutive days on Day 1 of each 21-day cycle OR 4 mg/m2 intravenously on Days 1, 8 and 15 of each 28-day cycle. Number of cycles: until tumor progression or unacceptable toxicity occurs

Also known as: Hycamtin

Topotecan

Eligibility Criteria

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

You may qualify if:

• Age ≥18 years male or female.
• Histological confirmation of SCLC.
• Relapsed or refractory to no more than 1 course of a systemic therapy regimen and is incurable by either surgery or radiation.
• Capable of providing informed consent and complying with trial procedures.
• ECOG PS 0-2.
• Life expectancy \>8 weeks.
• Measurable tumor lesions according to RECIST 1.1 criteria.\[22\]
• Women must not be able to become pregnant (e.g. post-menopausal for at least 1 year, surgically sterile, or practicing adequate birth control methods) for the duration of the study. (Adequate contraception includes: oral contraception, implanted contraception, intrauterine device implanted for at least 3 months, or barrier method in conjunction with spermicide.)
• Women of child bearing potential must have a negative serum or urine pregnancy test at the Screening Visit and be non-lactating.
• Accessibility to the site that ensures the subject will be able to keep all study-related appointments.

You may not qualify if:

• Prior exposure to \>375 mg/m2 of doxorubicin or liposomal doxorubicin.
• Prior treatment with topotecan.
• Palliative surgery and/or radiation treatment \< 21 days prior to date of randomization.
• Exposure to any investigational agent within 30 days of date of randomization.
• Exposure to any systemic chemotherapy within 21 days of date of randomization.
• Active (symptomatic) central nervous system (CNS) metastasis.
• History of other malignancies except cured basal cell carcinoma, cutaneous squamous cell carcinoma, melanoma in situ, superficial bladder cancer or carcinoma in situ of the cervix unless documented free of cancer for ≥3 years.
• Laboratory values: Screening serum creatinine \>1.5×upper limit of normal (ULN), alanine aminotransferase (ALT) \>3×ULN or \>5×ULN if liver metastases are present, total bilirubin \>2×ULN, absolute neutrophil count (ANC) \<1,500/mm3, platelet concentration \<100,000/mm3, hemoglobin \<9 g/dL, albumin \<2 gm/dL.
• Anion gap \> 16 meq/L or arterial blood pH \< 7.30.
• Clinically evident congestive heart failure (CHF) \> class II of the New York Heart Association (NYHA) guidelines (Appendix D).
• Current, serious, clinically significant cardiac arrhythmias, defined as the existence of an absolute arrhythmia or ventricular arrhythmias classified as Lown III, IV or V (Appendix F).
• Baseline QTc \>470 msec measured by Fridericia's formula (QTcF) and/or previous history of QT prolongation while taking other medications. Concomitant use of medications associated with a high incidence of QT prolongation is not allowed.
• History or signs of active coronary artery disease with angina pectoris within the last 6 months.
• Serious myocardial dysfunction defined by ECHO as absolute left ventricular ejection fraction (LVEF) below the institution's lower limit of predicted normal.
• Known history of HIV infection.

Sponsors & Collaborators

• ImmunityBio, Inc.: lead

Study Sites (29)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

City of Hope Medical Group

Pasadena, California, 91030, United States

Location

Cancer Specialists of North Florida-Fleming Island

Fleming Island, Florida, United States

Location

Northwest Georgia Oncology Centers, P.C.

Marietta, Georgia, 30060, United States

Location

James Graham Brown Cancer Center

Louisville, Kentucky, 40202, United States

Location

Oncology Hermatology Care, Inc.

Cincinnati, Ohio, 45242, United States

Location

Northwest CCOP Kaiser Permanente

Portland, Oregon, 97227, United States

Location

Penn State Hershey Cancer Institute

Hershey, Pennsylvania, 17033, United States

Location

Tennessee Oncology

Chattanooga, Tennessee, 37404, United States

Location

Tennessee Cancer Specialists

Knoxville, Tennessee, 37909, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

Koranyi National Institute of TBC and Pulmonologyhhy

Budapest, Hungary

Location

Koranyi National Institute of TBC and Pulmonology

Budapest, Hungary

Location

University of Debrecen, Medical and Health Science Center, Department of Pulmonology

Debrecen, Hungary

Location

Szabolcs-Szatmar-Bereg County Hospitals and University Teaching Hospital, Department of Pulmonology

Nyíregyháza, Hungary

Location

Medical Center of the University of Pecs, 1st Department of Internal Medicine

Pécs, Hungary

Location

Hetenyi Geza Hospital

Szolnok, Hungary

Location

Hospital General Universitario de Alicante

Alicante, Spain

Location

Hospital Clinic i Provincial de Barcelona

Barcelona, Spain

Location

Hospital Universitario Quiron-Dexeus (IOR)

Barcelona, Spain

Location

University Hospital Vall d'Hebron

Barcelona, Spain

Location

Hospital Universitario Lucus Augusti

Lugo, Spain

Location

General University Hospital Gregorio Maranon

Madrid, Spain

Location

Hospital Puerta de Hierro

Madrid, Spain

Location

University Hospital Foundation Jimenez Diaz

Madrid, Spain

Location

University Hospital La Paz

Madrid, Spain

Location

Hospital Regional Universitario

Málaga, Spain

Location

University Hospital Virgen de Valme

Seville, Spain

Location

CHU Xeral

Vigo, Spain

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

DOXO-EMCH; Topotecan

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)

Camptothecin; Alkaloids; Heterocyclic Compounds

Results Point of Contact

• Title: Sandeep Bobby Reddy, Chief Medical Officer
• Organization: ImmunityBio

Bobby.Reddy@Immunitybio.com

855-797-9277

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2014
• First Posted: July 25, 2014
• Study Start: April 20, 2015
• Primary Completion: May 15, 2017
• Study Completion: May 15, 2017
• Last Updated: June 25, 2024
• Results First Posted: June 25, 2024

Record last verified: 2016-01

Locations

ES (12); US (11); HU (6)