Replies to post #4908 on Ariad Pharmaceuticals Inc fka ARIA

[biotech_researcher]

I would guess that it is three months to dot the I's and cross the T's and get it into the final package.. Question. Does Ariad get paid at submission or, acceptance of the NDA?

[ariadndndough]

more details ????????? of Last follow-up date 2011-06 (Anticipated)
Primary completion date 2010-10 (Actual)


History of this study? Current version of this study
View of NCT00538239 on 2011_01_13
ClinicalTrials Identifier: NCT00538239
Updated: 2011_01_13
Descriptive Information
Brief title Ridaforolimus in Treatment of Sarcoma-SUCCEED (Sarcoma Multi-Center Clinical Eval. of the Efficacy of Ridaforolimus)(8669-011)

Official title A Pivotal Trial to Determine the Efficacy and Safety of AP23573 When Administered as Maintenance Therapy to Patients With Metastatic Soft-Tissue or Bone Sarcomas

Brief summary
The purpose of this study is to determine whether maintenance therapy with oral AP23573 (ridaforolimus), by preventing and controlling tumor growth for a prolonged period of time in patients with metastatic soft-tissue or bone sarcomas responding to chemotherapy, will result in clinically significant improvement in progression-free survival as compared to oral placebo.

Detailed description


Phase Phase 3
Study type Interventional
Study design Treatment
Study design Randomized
Study design Double Blind (Subject, Caregiver, Investigator)
Study design Placebo Control
Study design Parallel Assignment
Primary outcome Measure: Progression-free Survival
Time Frame: Duration of the study
Safety Issue? No
Secondary outcome Measure: Overall survival
Time Frame: Duration of the study
Safety Issue? No
Secondary outcome Measure: Anti-tumor response
Time Frame: Duration of the study
Safety Issue? No
Secondary outcome Measure: Change in cancer-related symptoms
Time Frame: Duration of the study
Safety Issue? No
Secondary outcome Measure: Safety and tolerability
Time Frame: 18 months
Safety Issue? Yes
Condition Metastatic Soft-Tissue Sarcomas
Condition Metastatic Bone Sarcomas
Arm/Group Arm Label: Ridaforolimus Experimental

Arm/Group Arm Label: Placebo Placebo Comparator

Intervention Drug: ridaforolimus Arm Label: Ridaforolimus
40 mg, Oral, QDx5 (five consecutive days each week followed by two day holiday) until disease progression

Intervention Drug: Placebo Arm Label: Placebo
Placebo

URL http://www.ariad.com/wt/tertiarypage/succeed_trial
See also

Recruitment Information
Status Active, not recruiting
Start date 2007-10
Last follow-up date 2011-06 (Anticipated)
Primary completion date 2010-10 (Actual)
Criteria
Inclusion Criteria:
- Confirmed diagnosis of metastatic soft-tissue or bone sarcoma
- Ongoing favorable outcome after a minimum of 4 cycles of prior chemotherapy for metastatic disease
- ECOG performance status of 0 or 1
- Age =13 years
- Adequate organ and bone marrow function
- Completed prior chemotherapy with last dose received at least 3 and up to 12 weeks prior to randomization

Exclusion Criteria:
- Prior therapy with rapamycin or rapamycin analogs
- Ongoing toxicity associated with prior anticancer therapy
- Another primary malignancy within the past three years
- Concomitant medications that induce or inhibit CYP3A
- Significant, uncontrolled cardiovascular disease

Gender Both
Minimum age 13 Years
Healthy volunteers No
Administrative Data
Organization name Merck
Organization study ID AP23573-07-302
Sponsor Merck
Collaborator Ariad Pharmaceuticals
Health Authority United States: Food and Drug Administration