EU Clinical Trial Information System (CTIS)

Brand Logo

Brand Logo Light

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

I searched for some studies on AstraZeneca Clinical Trials, and found these studies that may also be of interest to you.
Here is the link to my search results

Official Title

To assess the efficacy in terms of overall survival  of AZD6244 in combination with dacarbazine, compared with dacarbazine alone, in first line patients with BRAF mutation positive advanced cutaneous or unknown primary melanoma

Comparison of AZD6244 in combination with dacarbazine versus (vs) dacarbazine alone in BRAF mutation positive melanoma patients

NCT ID

Therapeutic Area

1000 mg/m2 iv infusion over at least 60 min. on day 1 of each 21 cycle

Cancer Study Locator (US and Canada only)

Research Site

A Phase II, Double-blind, Randomised study to assess the efficacy of AZD6244 in combination with dacarbazine compared with dacarbazine alone in first line patients with BRAF mutation positive advanced cutaneous or unknown primary melanoma

Age Continuous

Gender, Male/Female

Following progression survival data was collected until documentation of death, withdrawal of consent, loss to follow-up or the final data cut-off, whichever occurred first.

If the true hazard ratio (HR) is 0.57, 58 deaths provides at least 80% power to demonstrate a statistically significant difference for OS, assuming
a 1-sided 10% significance level.

Overall Survival

PFS is the time from randomisation until the date of objective disease progression as defined by Response Evaluation Criteria In Solid Tumours (RECIST version 1.1) or death (by any cause in the absence of progression). Progression is defined using RECIST (v1.1), as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm.

Progression free survival

Response

   Complete Response

   Partial Response

Non-response

   Stable Disease >=6 weeks

   Progression

ORR rate is defined as the number (%) of subjects with at least one visit response of Complete Response (CR) or Partial Response (PR) , as defined by Response Evaluation Criteria in Solid Tumours (RECIST v1.1) for target lesions and assessed by CT or MRI. CR, Disappearance of all target lesions; PR, ≥30% decrease in the sum of the longest diameter of target lesions. Data obtained up until progression, or last evaluable assessment in the absence of progression, was included in the assessment of ORR

Arms	Assigned Interventions
Active Comparator: 1 AZD6244 in combination with dacarbazine	Drug: AZD6244 oral capsules, 75mg twice daily Other Name: selumetinib Drug: Dacarbazine 1000 mg/m2 iv infusion over at least 60 min. on day 1 of each 21 cycle Other Name: DTIC
Placebo Comparator: 2 Placebo in combination with dacarbazine	Drug: Dacarbazine 1000 mg/m2 iv infusion over at least 60 min. on day 1 of each 21 cycle Other Name: DTIC Drug: Placebo Placebo

Comparison of AZD6244 in combination with dacarbazine versus (vs) dacarbazine alone in BRAF mutation positive melanoma patients

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Documents available

Cancer Study Locator (US and Canada only)

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=195&filename=CSP-D1532C00006.pdf

D1532C00006.pdf

Trial Results Summaries

Contacts

Contact

Contact Backup

Investigators

Principal Investigator