Pazopanib in Relapsed and Refractory Small Cell Lung Cancer

NCT01713296 | Completed Phase 2

• 1 other identifier: CT/11.01
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 8

Brief Summary

Investigators propose to study the single agent activity of pazopanib in a Phase II trial of patients with relapsed or refractory small cell lung cancer. Because these patients have very limited treatment options, use of an investigational agent in this patient population is supported by current National Comprehensive Cancer Network guidelines. Using correlative biologic studies to evaluate the anti angiogenic activity of pazopanib in the absence of concomitant chemotherapy will allow us to delineate the responses due to this drug and the effect on angiogenesis. Pazopanib dose has been determined to 800 mg once daily per the initial recommended dose approved by FDA and EMA, as monotherapy in advanced Renal Cell Carcinoma

Conditions

SCLC

Keywords

SCLC; 2nd Line; Relapsed or Refractory

Outcome Measures

Primary Outcomes (1)

• Progression Free Rate

  Patients will be assessed every 8 weeks, from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, up to 168 weeks

  2 Years

Secondary Outcomes (2)

• Overall Survival

  3 years

• Toxicity profile

  Every 4 weeks

Study Arms (1)

Pazopanib

EXPERIMENTAL

Drug: Pazopanib

Interventions

Pazopanib DRUG

Also known as: Pazopanib: 800mg once a day for up to 2 years from date of first dose

Pazopanib

Eligibility Criteria

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

You may qualify if:

• Patients must provide written informed consent prior to performance of study-specific procedures or assessments, and must be willing to comply with treatment and follow up Procedures conducted as part of the patient's routine clinical management (e.g., blood count, imaging study) and obtained prior to signing of informed consent may be utilized for screening or baseline purposes provided these procedures are conducted as specified in the protocol
• Age ≥ 18 years
• Diagnosis of SCLC based on either histology or cytology (by FNA) with radiologically confirmed progressive disease after first-line chemotherapy.
• Presence of brain metastases is permitted if patient has completed treatment with surgery and/or radiation more than four weeks prior to date of first dose of study drug. Patients who have developed brain metastases following prophylactic cranial irradiation will not be eligible for participation
• Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
• Measurable disease criteria according to RECIST 1.1
• Only one prior chemotherapy regimen
• Biologic material (blood samples, archived tissue) will be collected from consenting patients for biomarker analysis before and/or during treatment with investigational product
• Adequate organ system function
• Localised irradiation for SCLC is permitted as long as it was a minimum of 4 weeks before entering the study; however, single-dose palliative radiation of bone metastases for pain control may be allowed during the 4-week screening period
• A female is eligible to enter and participate in this study if she is of:
• Non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who has had: A hysterectomy, A bilateral oophorectomy (ovariectomy), A bilateral tubal ligation, Is post-menopausal
• Patients not using hormone replacement therapy (HRT) must have experienced total cessation of menses for ≥ 1 year and be greater than 45 years in age, OR, in questionable cases, have a follicle stimulating hormone (FSH) value \>40 mIU/mL and an estradiol value \< 40pg/mL (\<140 pmol/L)
• Patients using HRT must have experienced total cessation of menses for \>= 1 year and be greater than 45 years of age OR have had documented evidence of menopause based on FSH and estradiol concentrations prior to initiation of HRT Childbearing potential, including any female who has had a negative serum pregnancy test within 2 weeks prior to the first dose of study treatment, preferably as close to the first dose as possible, and agrees to use adequate contraception. GSK acceptable contraceptive methods, when used consistently and in accordance with both the product label and the instructions of the physician, are as follow: Complete abstinence from sexual intercourse for 14 days before exposure to investigational product, through the dosing period, and for at least 21 days after the last dose of investigational product. Oral contraceptive, either combined or progestogen alone. Injectable progestogen.Implants of levonorgestre. Estrogenic vaginal ring. Percutaneous contraceptive patches. Intrauterine device (IUD) or intrauterine system (IUS) with a documented failure rate of less than 1% per year. Male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study, and this male is the sole partner for that subject. Double barrier method: condom and an occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal agent (foam/gel/film/cream/suppository) Female subjects who are lactating should discontinue nursing prior to the first dose of study drug and should refrain from nursing throughout the treatment period and for 14 days following the last dose of study drug

You may not qualify if:

• Prior malignancy
• Prior use of an investigational or licensed drug that targets VEGF or VEGF receptors
• Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding including, but not limited to:
• Active peptic ulcer disease
• Known intraluminal metastatic lesion/s with risk of bleeding
• Inflammatory bowel disease (e.g. ulcerative colitis, Chrohn's disease), or other gastrointestinal conditions with increased risk of perforation
• History of abdominal fistula, gastrointestinal perforation, or intra abdominal abscess within 28 days prior to beginning study treatment
• Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product including, but not limited to: Malabsorption syndrome, Major resection of the stomach or small bowel
• Presence of uncontrolled infection.
• Corrected QT interval (QTc) \> 480 msecs using Bazett's formula
• History of any one or more of the following cardiovascular conditions within the past 6 months: Cardiac angioplasty or stenting, Myocardial infarction, Unstable angina, Coronary artery bypass graft surgery, Symptomatic peripheral vascular disease, Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA)
• Poorly controlled hypertension \[defined as systolic blood pressure (SBP) of ≥140 mmHg or diastolic blood pressure (DBP) of ≥ 90mmHg\]
• History of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months
• Prior major surgery or trauma within 28 days prior to first dose of study drug and/or presence of any non-healing wound, fracture, or ulcer (procedures such as catheter placement not considered to be major)
• Evidence of active bleeding or bleeding diathesis

Sponsors & Collaborators

• Hellenic Oncology Research Group: lead

Study Sites (8)

"Agioi Anargyroi" Anticancer Hospital of Athens

Athens, Greece

Location

"IASO" General Hospital of Athens

Athens, Greece

Location

401 Military Hospital of Athens

Athens, Greece

Location

Air Forces Military Hospital of Athens

Athens, Greece

Location

University Hospital of Crete, Dep of Medical Oncology Heraklion, Greece

Heraklion, Greece

Location

"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology

Piraeus, Greece

Location

"Papageorgiou" Hospital of Thessaloniki

Thessaloniki, Greece

Location

"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology

Thessaloniki, Greece

Location

MeSH Terms

Conditions

Recurrence

Interventions

pazopanib

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2012
• First Posted: October 24, 2012
• Study Start: November 1, 2011
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: October 8, 2015

Record last verified: 2015-10

Locations

GR (8)