AP23573-07-302: A clinical trial to determine the safety and efficacy of an anti-cancer drug AP23573 when given as maintenace therapy in patients with having soft-tissue or Bone cancer after they have received planned therapy

AP23573-07-302: 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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2008/091/000008

Enrollment

650

Registered

2008-03-11

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Drug: deforolimus (AP23573, MK-8669): Drug: deforolimus (AP23573, MK-8669) 40 mg, Oral, QDx5 (five consecutive days each week followed by two day holiday) until disease progression Co

Eligibility

Inclusion criteria

Inclusion criteria: 1. Confirmed diagnosis of metastatic soft-tissue or bone sarcoma 2. Ongoing favorable outcome after a minimum of 4 cycles of prior chemotherapy for metastatic disease 3. ECOG performance status of 0 or 1 4. Age &#8805;13 years 5. Adequate organ and bone marrow function 6. Completed prior chemotherapy with last dose received at least 3 and up to 8 weeks prior to randomization

Exclusion criteria

Exclusion criteria: 1. Women who are pregnant or lactating 2. Presence of known or active brain or CNS metastases 3. Prior therapy with rapamycin or rapamycin analogs, including AP23573 4. Concomitant treatment with medications that induce or inhibit CYP3A

Design outcomes

Primary

Measure	Time frame
Progression-free SurvivalTimepoint: 12 months	—

Secondary

Measure	Time frame
Overall survival, antitumor response, change in cancer-related symptoms, safety, and tolerabilityTimepoint: 42 months	—

Countries

India

Contacts

Public ContactMr. Bharat Doshi

shetty.prasad@kendle.com79 40213600

Outcome results