Topotecan Liposomes Injection for Small Cell Lung Cancer (SCLC), Ovarian Cancer and Other Advanced Solid Tumors

NCT00765973 | Completed Phase 1

• 1 other identifier: HBS601
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 2

Brief Summary

A multi-center, open-label, two-arm, dose-escalation study to establish the safety, tolerability, MTD, and schedule of TLI administered intravenously as a 30 minute infusion in adult subjects with advanced solid tumors that have relapsed, are refractory to standard therapy, or for whom there is no standard therapy available. The two dosing regimens to be evaluated are:

• Arm A: TLI dose on Days 1 and 8 of a 21-day treatment cycle (Starting dose: 1 mg/m2)
• Arm B: TLI dose on Day 1 of a 21-day treatment cycle (Starting dose: 2 mg/m2) When one of the two arms reaches MTD, all future subjects will then be enrolled in the remaining study arm until MTD of that arm is reached.

Conditions

Small Cell Lung Cancer; Ovarian Cancer; Solid Tumors

Keywords

Other Advanced Solid Tumors

Outcome Measures

Primary Outcomes (1)

• Evaluate the safety, tolerability and maximum tolerated dose of 2 different dosing schedules of TLI administered intravenously

  21 days following initial dose

Secondary Outcomes (1)

• Assess the pharmacokinetic profile of TLI

  21 Day Cycle

Study Arms (2)

A

EXPERIMENTAL

Arm A: TLI dose on Days 1 and 8 of a 21-day treatment cycle (Starting dose: 1 mg/m2)

Drug: Topotecan Liposomes Injection (TLI)

B

EXPERIMENTAL

Arm B: TLI dose on Day 1 of a 21-day treatment cycle (Starting dose: 2 mg/m2)

Drug: Topotecan Liposomes Injection (TLI)

Interventions

Topotecan Liposomes Injection (TLI) DRUG

TLI dose on Days 1 and 8 of a 21-day treatment cycle (Starting dose: 1 mg/m2)

A

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
• Histologically or cytologically confirmed advanced solid tumor that has relapsed, is refractory to standard treatment, or for whom there is no standard therapy available.
• Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
• Normal organ and marrow function as defined below within 14 days of study entry
• Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
• Platelet count ≥100 x 109/L
• Hemoglobin ≥ 9 g/dL
• Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x upper limit of normal (ULN), or 5 x ULN for subjects with liver metastases
• Serum creatinine ≤ 1.5 x ULN or calculated estimated creatinine clearance ≥ 50 mL/min/1.73m2 for subjects with creatinine levels above institutional normal based on the Cockcroft and Gault formula.
• Never received prior TLI or topotecan HCl (Hycamtin®)
• At least 4 weeks must have elapsed from the last dose of chemotherapy.
• Life expectancy ≥ 3 months
• Women of childbearing potential must have a negative urine or blood pregnancy test within 7 days prior to initiation of treatment.
• If female, subject is post-menopausal, surgically sterilized, or willing to use acceptable methods of birth control (e.g., hormonal contraceptive, intra-uterine device (IUD), diaphragm with spermicide, condom with spermicide or abstinence) from the screening visit through the duration of study participation.

You may not qualify if:

• Use of any investigational drugs, biologics, or devices within 28 days prior to study treatment or planned use during the course of the study.
• Primary tumors of central nervous system (CNS). Symptomatic brain metastases (unless subject is stable without requirement of steroids and/or antiseizure medications for at least three months) or leptomeningeal tumor involvement. Imaging studies are not required to rule this out unless there is a clinical suspicion of CNS disease.
• Prior chemotherapy or radiotherapy within 4 weeks of Day 1 of study (6 weeks for nitrosureas or mitomycin C).
• Planned concurrent systemic therapy (cytotoxic and/or cytostatic) and/or radiotherapy during study treatment.
• Less than 4 weeks have elapsed from the time of major surgery.
• Subjects with a history of allergic reactions or sensitivity attributed to compounds of similar chemical or biologic composition to TLI, including known allergies to the ingredients comprising the liposome (e.g., cholesterol and/or sphingomyelin), which in the Investigator's opinion may put the subject at risk for significant reaction to the study drug.
• Subjects who are pregnant or lactating.
• Subjects known to be positive for human immunodeficiency virus (HIV), hepatitis C antibody, or hepatitis B surface antigen.
• Prophylactic hematologic growth factors administered ≤ 2 weeks prior to start of treatment with TLI (excluding darbepoetin alfa and epoetin alfa).
• Active infection or any serious underlying medical condition, which would impair the ability of the subject to receive protocol treatment.

Sponsors & Collaborators

• Spectrum Pharmaceuticals, Inc: lead

Study Sites (2)

Barbara Ann Karmanos Cancer Center

Detroit, Michigan, 48201, United States

Location

South Texas Accelerated Research Therapeutics

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma; Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Design

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

Study Record Dates

• First Submitted: October 1, 2008
• First Posted: October 3, 2008
• Study Start: November 10, 2008
• Primary Completion: June 30, 2010
• Study Completion: June 30, 2010
• Last Updated: November 13, 2020

Record last verified: 2020-11

Locations

US (2)