Ignite Creation Date:
2024-05-06 @ 3:08 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04538625
Status:
COMPLETED
Last Update Posted:
2024-04-15
First Post:
2020-08-28
Brief Title:
Prophylaxis of Diarrhea in Adult Cancer Patients Receiving Targeted Cancer Therapy
Sponsor:
Napo Pharmaceuticals Inc
Organization:
Napo Pharmaceuticals Inc
Study Overview
Official Title:
A Phase 3 Multicenter Randomized Double-blind Placebo-controlled Trial Evaluating Crofelemer for the Prophylaxis of Diarrhea in Adult Patients With Solid Tumors Receiving Targeted-cancer Therapies With or Without Standard Chemotherapy
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OnTARGET
Brief Summary:
A 24-week two 12-week stages randomized placebo-controlled double-blind study to evaluate the safety and efficacy of crofelemer in providing prophylaxis of diarrhea in adult patients with solid tumors treated with targeted cancer therapy-containing treatment regimens Diarrhea grading will be done according to the National Cancer Institute Common Terminology Criteria for Adverse Events NCI CTCAE version 50
Patients will be randomized 11 to placebo or crofelemer and will be stratified by the type of targeted cancer therapy and the tumor type Placebo andor crofelemer will be dispensed at Visit 1Day 1 with the concurrent start of the targeted cancer therapy regimen The initial Stage I double-blind placebo-controlled primary treatment phase will occur over a 12-week period to accommodate approximately 3 cycle chemotherapy cancer treatment dosing-cycles The Primary and Secondary Endpoints will be analyzed after the last patient last visit LPLV of Stage I
After completing the Stage I double-blind placebo-controlled primary treatment phase the subjects will have the option to remain on their assigned treatment arm and reconsented to enter into the Stage II extension phase Reconsent will be required to enter into Stage II For subjects who do not reconsent visit 5 will be the last study visit
Patients will be randomized 11 to placebo or crofelemer and will be stratified by the type of targeted cancer therapy and the tumor type Placebo andor crofelemer will be dispensed at Visit 1Day 1 with the concurrent start of the targeted cancer therapy regimen The initial Stage I double-blind placebo-controlled primary treatment phase will occur over a 12-week period to accommodate approximately 3 cycle chemotherapy cancer treatment dosing-cycles The Primary and Secondary Endpoints will be analyzed after the last patient last visit LPLV of Stage I
After completing the Stage I double-blind placebo-controlled primary treatment phase the subjects will have the option to remain on their assigned treatment arm and reconsented to enter into the Stage II extension phase Reconsent will be required to enter into Stage II For subjects who do not reconsent visit 5 will be the last study visit
Detailed Description:
A randomized placebo controlled double blind study to evaluate the safety and efficacy of crofelemer in providing prophylaxis of diarrhea in adult patients with solid tumors receiving targeted cancer therapy containing regimens Diarrhea grading will be done according to the National Cancer Institutes Common Terminology Criteria for Adverse Events CTCAE Ver 50
Randomization will be at a 11 ratio with subjects randomized either to crofelemer 125 mg delayed-release tablets or matching placebo tablets administered orally twice daily with or without food Randomization will be stratified by the type of targeted cancer therapy and by tumor type Placebo and crofelemer treatment will be initiated concomitantly with the administration of targeted cancer therapy-containing regimens
The Stage I double-blind placebo-controlled primary treatment phase will be the first 12-week period to accommodate targeted cancer therapy with approximately three 3 cycle chemotherapy regimens if needed over the inclusive 12-week period after initiation of crofelemer or placebo treatment in Stage I
After completing the Stage I treatment phase 12 weeks and after the LPLV of the primary Stage I treatment phase the primary and secondary endpoints will be analyzed The subjects will have the option to remain on their assigned treatment arm and reconsented to enter into the Stage II extension phase Reconsent will be required to enter into Stage II For subjects who do not reconsent Visit 5 will be the last study visit Subjects who enter into the Stage II extension phase will continue on their originally assigned study treatment commenced at the beginning of Stage I
Randomization will be at a 11 ratio with subjects randomized either to crofelemer 125 mg delayed-release tablets or matching placebo tablets administered orally twice daily with or without food Randomization will be stratified by the type of targeted cancer therapy and by tumor type Placebo and crofelemer treatment will be initiated concomitantly with the administration of targeted cancer therapy-containing regimens
The Stage I double-blind placebo-controlled primary treatment phase will be the first 12-week period to accommodate targeted cancer therapy with approximately three 3 cycle chemotherapy regimens if needed over the inclusive 12-week period after initiation of crofelemer or placebo treatment in Stage I
After completing the Stage I treatment phase 12 weeks and after the LPLV of the primary Stage I treatment phase the primary and secondary endpoints will be analyzed The subjects will have the option to remain on their assigned treatment arm and reconsented to enter into the Stage II extension phase Reconsent will be required to enter into Stage II For subjects who do not reconsent Visit 5 will be the last study visit Subjects who enter into the Stage II extension phase will continue on their originally assigned study treatment commenced at the beginning of Stage I
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None