A Phase 1/2a Study of ABT-263 in Subjects With Small Cell Lung Cancer (SCLC) or Other Non-Hematological Malignancies

Sponsor

AbbVie (prior sponsor, Abbott) (Industry)

Overall Status

Completed

CT.gov ID

NCT00445198

Collaborator

Genentech, Inc. (Industry)

Enrollment

Locations

Arm

Duration (Months)

4.8

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The Phase 1 portion of the study will evaluate the pharmacokinetic profile and safety of ABT-263 with the objective of defining the dose limiting toxicity and maximum tolerated dose. (This portion of the study is complete). The Phase 2a portion of the study will evaluate ABT-263 at the defined recommended Phase 2 dose to obtain additional safety information and a preliminary assessment of efficacy.

Condition or Disease	Intervention/Treatment	Phase
Small Cell Lung Cancer Small Cell Lung Carcinoma	Drug: ABT-263	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

86 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase 1/2a Study Evaluating the Safety, Pharmacokinetics, and Efficacy of ABT-263 in Subjects With Small Cell Lung Cancer or Other Non-Hematological Malignancies

Study Start Date :

Apr 1, 2007

Actual Primary Completion Date :

Dec 1, 2010

Actual Study Completion Date :

Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Phase 1 and Phase 2a	Drug: ABT-263 Phase 1 dosing under two different schedules: 14 days on drug, 7 days off or continuous dosing. - 50 patients with SCLC and non-hematologic malignancies. Enrollment is closed in this arm of the study. Phase 2a dosing under two different schedules: 14 days on drug, 7 days off or continuous dosing. - 40 patients with SCLC

Arm

Intervention/Treatment

Experimental: Phase 1 and Phase 2a

Drug: ABT-263

Phase 1 dosing under two different schedules: 14 days on drug, 7 days off or continuous dosing. - 50 patients with SCLC and non-hematologic malignancies. Enrollment is closed in this arm of the study. Phase 2a dosing under two different schedules: 14 days on drug, 7 days off or continuous dosing. - 40 patients with SCLC

Outcome Measures

Primary Outcome Measures

Safety assessment [Repeating sequence of 14 days on therapy and 7 days off or continuous dosing]
Dose limiting toxicity determination [Repeating sequence of 14 days on therapy and 7 days off or continuous dosing]
Maximum tolerated dose determination [Repeating sequence of 14 days on therapy and 7 days off or continuous dosing]
Pharmacokinetic profile evaluation [Repeating sequence of 14 days on therapy and 7 days off or continuous dosing]

Secondary Outcome Measures

Extended safety assessment at the recommended Phase 2 dose [Repeating sequence of 14 days on therapy and 7 days off or continuous dosing]
Preliminary efficacy assessment [Repeating sequence of 14 days on therapy and 7 days off or continuous dosing]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

The subject must be >=18 years of age.(Phase 1 & 2a)
Histologically and/or cytologically documented diagnosis of small cell lung cancer (North America & UK) or other non-hematological malignancy (North America only).(Phase 1 only)
Histologically and/or cytologically documented diagnosis of SCLC.(Phase 2a)
At least one prior chemotherapy treatment regimen(s) and their disease is refractory or experienced progressive disease following the treatment.(Phase 1)
Extensive-stage SCLC & is chemotherapy naïve(US only) has experienced progressive disease following at least one chemotherapy regimen or their disease is refractory.(Phase 2a)
Brain metastases with clinically controlled neurologic symptoms, defined as surgical excision and/or radiation therapy followed by 21 days of stable neurologic function & no evidence of CNS disease progression as determined by CT or MRI within 21 days prior to the first dose of study drug.
ECOG performance score <= 2(Ph 1) <=1(Phase 2a)
Must be receiving a stable dose of Selective Serotonin Reuptake Inhibitor (SSRI) anti-depressants 21 days prior to 1st dose of study drug.
Adequate bone marrow, renal & hepatic function per local lab reference range at

Screening as follows:

Bone marrow: Absolute Neutrophil count (ANC)>=1000/µL
Platelets>= 100,000/mm3
Hemoglobin>=9.0g/dL
Renal function: Serum creatinine<= 2.0mg/dL or calculated creatinine clearance>=50mL/min
Hepatic function&enzymes: AST and ALT<=3.0 x the upper normal limit(ULN) of institution's normal range
Bilirubin<=1.5xULN. If Gilbert's Syndrome may have Bilirubin> 1.5 x ULN
Coagulation: aPTT and PT<=1.2 x the upper limit of normal
Should have archived diagnostic tissue available for assessment of Bcl-2 family protein expression.(Phase 2a)
All female subjects not surgically sterile or postmenopausal(for at least 1 year)and non-vasectomized male subject must practice at least one method of birth control.

Exclusion Criteria:

Underlying or predisposing condition of bleeding or currently exhibits signs of bleeding.
Recent history of non-chemotherapy induced thrombocytopenia associated bleeding within 1 year prior to first dose of study drug.
Active peptic ulcer disease or other potentially hemorrhagic esophagitis/gastritis.
The subject has active immune thrombocytopenic purpura (ITP),active autoimmune hemolytic anemia (AIHA), or a history of being refractory to platelet transfusions (within 1 year prior to the first dose of study drug).
Currently receiving or requires anticoagulation therapy or any drug or herbal supplements that affect platelet function, with exception of low-dose anticoagulation medications that are used to maintain the patency of a central intravenous catheter.
Received any anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy, hormonal (with the exception of hormones for hypothyroidism or estrogen replacement therapy (ERT), anti estrogen analogs, agonists required to suppress serum testosterone levels), or any investigational therapy within 14 days prior to the first dose of study drug, or has not recovered to less than a grade 2 adverse effect(s) of the previous therapy.
Received a biologic (G-CSF, GM-CSF or erythropoietin) within 28 days prior to the first dose of study drug.
Steroid therapy for anti-neoplastic intent within seven days prior to the first dose of study drug.
Has consumed grapefruit or grapefruit products within 3 days prior to the first dose of study drug.
Significant history of cardiovascular disease, renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, or hepatic disease that in the opinion of the investigator would adversely affect his/her participating in this study.
Positive for HIV
A history of other active malignancies within the past 3 years prior to screening, with the exception of:
Adequately treated in situ carcinoma of the cervix uteri
Basal or squamous cell carcinoma of the skin
Previous malignancy confined and surgically resected with curative intent
Evidence of other clinically significant uncontrolled condition(s) including, but not limited to:
Active systemic fungal infection
Diagnosis of fever and neutropenia within 1 week prior to study drug administration.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Site Reference ID/Investigator# 13605	Peoria	Arizona	United States	85381
2	Site Reference ID/Investigator# 5261	Phoenix	Arizona	United States	85013
3	Site Reference ID/Investigator# 11942	Los Angeles	California	United States	90095-7187
4	Site Reference ID/Investigator# 4718	Sacramento	California	United States	95817
5	Site Reference ID/Investigator# 3755	Aurora	Colorado	United States	80045-0510
6	Site Reference ID/Investigator# 8324	Atlanta	Georgia	United States	30322
7	Site Reference ID/Investigator# 2623	Chicago	Illinois	United States	60612
8	Site Reference ID/Investigator# 2625	Baltimore	Maryland	United States	21231-1000
9	Site Reference ID/Investigator# 12343	Bethesda	Maryland	United States	20892
10	Site Reference ID/Investigator# 11941	Boston	Massachusetts	United States	02215
11	Site Reference ID/Investigator# 2626	Boston	Massachusetts	United States	02215
12	Site Reference ID/Investigator# 4934	Charlotte	North Carolina	United States	28204
13	Site Reference ID/Investigator# 2624	Nashville	Tennessee	United States	37203
14	Site Reference ID/Investigator# 6650	Tacoma	Washington	United States	98405
15	Site Reference ID/Investigator# 7493	Edmonton		Canada	T6G 1Z2
16	Site Reference ID/Investigator# 7635	Ottawa		Canada	K1H 8L6
17	Site Reference ID/Investigator# 18541	Leicester		United Kingdom	LE1 5WW
18	Site Reference ID/Investigator# 2622	Manchester		United Kingdom	M20 4BX

Sponsors and Collaborators

AbbVie (prior sponsor, Abbott)
Genentech, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

AbbVie (prior sponsor, Abbott)

ClinicalTrials.gov Identifier:

NCT00445198

Other Study ID Numbers:

M06-822
2006-003298-28
NCT00929513

First Posted:

Mar 8, 2007

Last Update Posted:

Jun 6, 2018

Last Verified:

Jan 1, 2013

Keywords provided by AbbVie (prior sponsor, Abbott)

SCLC

Additional relevant MeSH terms:

Lung Neoplasms

Small Cell Lung Carcinoma

Navitoclax

Study Results

No Results Posted as of Jun 6, 2018