Paclitaxel with or without GSK1120212 for treatment of melanoma

Phase 2

Completed

• Conditions: Melanoma; Cancer; Melanoma and other malignant neoplasms of skin

• Registration Number: ISRCTN43327231
• Lead Sponsor: niversity of Oxford (UK)

Brief Summary

1. 2015 results for dose escalation phase in https://www.ncbi.nlm.nih.gov/pubmed/25542057 2. 2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/30428063 3. 2020 results in https://www.ncbi.nlm.nih.gov/pubmed/31987431 (added 29/01/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-04-27
• Study Completion: 2016-04-30
• Last Update Posted: 24 February 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 111

Inclusion Criteria

1. Aged = 18 years
2. Able to provide evidence from an accredited laboratory of wt BRAF status for their melanoma, or ascertainment of wild type BRAF status from a sample of melanoma provided for mutational analysis in Oxford (phase 2 part only).
3. Unresectable stage 3 or 4, histologically proven cutaneous or unknown primary melanoma
4. Measurable disease as defined by RECIST 1.1 (phase 2 part only)
5. ECOG performance score of 0 or 1
6. Life expectancy of at least 12 weeks.
7. Maximum 2 prior lines of treatment for advanced disease.
8. Adequate cardiac function (NYHA 0-1), and LVEF within normal limits on echocardiogram.
9. The patient is willing to give consent to the main study and able to comply with the protocol for the duration of the study, including scheduled follow-up visits and examinations.
10. Adequate haematological, hepatic and renal function
11. Target Gender: Male & Female
12. Lower Age Limit 18 years

Exclusion Criteria

1. Any systemic anti-cancer therapy (including participation in other clinical trials) within 28 days prior to Day 1.
2. Any radiotherapy within 14 days prior to Day 1.
3. Prior taxane or BRAF or MEK inhibitors for metastatic melanoma.
4. Any unresolved toxicity from prior anti-cancer therapy that is greater than CTCAE grade 2.
5. Pregnancy or breastfeeding women. Female patients must have a negative urinary or serum pregnancy test or have evidence of post-menopausal status (defined as absence of menstruation for > 12 months, bilateral oophrectomy or hysterectomy).
6. Grade =2 peripheral neuropathy at study entry.
7. Patients of reproductive potential who are not willing to use adequate contraceptive measures for the duration of the study (both male and female patients)
8. Known severe hypersensitivity reactions to paclitaxel or other drugs formulated in Cremophor EL and ethanol
9. Ocular or mucosal malignant melanoma
10. Another active malignancy within the past three years.
11. Evidence of brain metastases, unless surgically resected/stereotactic radiosurgery treated brain metastasis with no evidence of relapse on cerebral MRI, or treated brain metastasis and stable off treatment, including steroids, for 3 months.
12. Clinically significant and uncontrolled major medical condition(s): such as active infection, bleeding diathesis.
13. Patients who are known to be serologically positive for Hepatitis B, Hepatitis C or HIV.
14. Inability to swallow tablets, refractory nausea and vomiting, chronic gastrointestinal diseases (eg, inflammatory bowel disease) or significant bowel resection that would preclude adequate absorption.
15. Ocular disease predisposing to central serous retinopathy and/or retinal vein occlusion, including increased intraocular pressure, glaucoma, uncontrolled hypertension or uncontrolled diabetes.

Study & Design

• Study Type: Interventional
• Study Design: Not specified