A study to compare the tablet and oral solution formulations of GSK1120212 in cancer patients

Active, not recruiting

• Conditions: GSK1120212 is currently being developed for a number of solid tumors, including metastatic BRAF-mutant melanoma (Phase 3), pancreatic cancer (Phase 2) and non small cell lung cancer (Phase 2), and in hematological malignancies, including acute-myeloid leukemia (AML) or chronic myelo-monocytic leukemia (CMML).; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-004901-25-Outside-EU/EEA
• Lead Sponsor: GlaxoSmithKline Research and Development Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07-25
• Last Update Posted: 31 July 2012

Recruitment & Eligibility

• Status: Active
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

1. Male or female, 18 years of age or older, at the time of signing the informed consent.
2. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
3. Able to swallow and retain oral medication.
4. Histologically- or cytologically-confirmed diagnosis of a solid tumor malignancy that is not responsive to standard therapies; or for which there is no approved or curative therapy; or for subjects which refuse standard therapy.
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
6. Adequate baseline organ function as defined in Table 4 in the protocol.
7. Women of child-bearing potential must have a negative serum pregnancy test within 14 days of first dose of investigational product administration and agree to use effective contraception, as defined in Section 7.1.1 of the protocol, during the study and for 6 weeks following the last dose of investigational product.
8. Male subjects with female partners of child-bearing potential must agree to use one of the contraception methods listed in Section 7.1 of the protocol. This criterion must be followed from the time of the first dose of study medication until 16 weeks after
the last dose of GSK1120212.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 18
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1. Currently receiving cancer therapy (e.g., chemotherapy with delayed toxicity, extensive radiation therapy, immunotherapy, biologic therapy, or major surgery) within 3 weeks prior to randomization; chemotherapy regimens without delayed toxicity within 2 weeks prior to randomization; or use of an investigational anticancer drug within 4 weeks prior to randomization.
2. Unresolved Grade 2 or greater toxicity (based on NCI-CTCAE, version 4.0 [NCI-CTCAE, 2009]) from previous anti-cancer therapy except Grade 2 decreased haemoglobin levels or alopecia.
3. Pre-existing peripheral neuropathy = Grade 2.
4. Has participated in a clinical trial and received investigational product within 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product, whichever is longer, prior to the first dose of investigational product in this study.
5. Has participated in a clinical trial that resulted in or made a donation of blood or blood products in excess of 500mL within 56 days of the first dose of investigational product in this study.
6. Has presence of active GI disease or other condition (e.g., gastrectomy, bariatric surgery, small or large bowel resection, or cholecystectomy) that may interfere significantly with absorption of drugs.
7. Any serious and/or unstable pre-existing medical (aside from malignancy exception above), psychiatric disorder, or other conditions that could interfere with subject’s safety, obtaining informed consent or compliance with the study procedures, in the opinion of the investigator or the GSK medical monitor.
8. History of interstitial lung disease or pneumonitis.
9. History or current evidence / risk of retinal vein occlusion (RVO) or central serous retinopathy (CSR):
• History of RVO or CSR, or predisposing factors to RVO or CSR (e.g., uncontrolled glaucoma or ocular hypertension, uncontrolled systemic disease(s) such as hypertension diabetes mellitus, or history of hyperviscosity or hypercoagulability syndromes).
• Visible retinal pathology as assessed by ophthalmic exam that is considered a risk factor for RVO or CSR such as:
• Evidence of new optic disc cupping
• Evidence of new visual field defects
• Intraocular pressure > 21mm Hg
10. Has symptomatic or untreated leptomeningeal or brain metastases or spinal cord compression
NOTE: Subjects previously treated for these conditions that have had stable central nervous system (CNS) disease (verified with consecutive imaging studies) for >3 months, are asymptomatic and are not currently taking corticosteroids, or are on stable dose of corticosteroids for at least 1 month prior to Day 1 of the study are permitted. Subjects are not permitted to receive enzyme-inducing anti-epileptic drugs (EIAEDs).
11. QTcB or QTcF =480msec.
12. Subject has a history or evidence of cardiovascular risk, including any of the following:
• History or evidence of current clinically significant uncontrolled arrhythmias. Exception: subjects with controlled atrial fibrillation for >30days prior to randomization are eligible.
• History of acute coronary syndromes, including myocardial infarction and unstable angina, coronary angioplasty, or stenting, within 6months prior to randomization.
13. History or evidence of current =Class II congestive heart failure as defined by New York Heart Association (NYHA; Appendix 1).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified