45 results
Primary phase 1: To determine MTD and/or RP2D of INC280 incombination with erlotinibPrimary phase 2: To compare the antitumor activity of INC280 alone, and INC280 in combination with erlotinib, vs platinum with pemetrexed, as measured by Progression…
The objectives of the Phase 1 dose escalation are:Primary Objectives:* To establish the Maximum Tolerated Dose (MTD) and to establish the Recommended Phase 2 Dose (RPTD) for veliparib in combination withcarboplatin and etoposide.* To evaluate the…
To compare the efficacy of six cycles neoadjuvant PTC plus pertuzumab preceded by either three cycles of FEC-T plus pertuzumab or three cycles of PTC plus pertuzumab in HER2 positive breast cancerSecondary objectives• To describe the safety of the…
The primary objective of the study is to assess whether the addition of oral veliparib to carboplatin and paclitaxel will improve overall survival (OS) in current smokers when compared to the addition of placebo to carboplatin and paclitaxel, in…
Primary objective:· To determine the disease control rate as defined by RECIST assessment criteria [Complete Response (CR) + Partial Response (PR) + Stable Disease (SD) rates] for both Vinflunine-Gemcitabine and Vinflunine-Carboplatin combinations.…
Objective: The primary objectives of this study are comparing the duration of recurrence free survival following completion of treatment between the 2 study arms. Secondary objectives of this study involves toxicity and morbidity, quality of life,…
The primary objective of the study is to assess the progression-free survival (PFS) of oralveliparib in combination with temozolomide (TMZ) or in combination with carboplatin and paclitaxel compared to placebo plus carboplatin and paclitaxel.The…
To demonstrate efficacy of adjuvant combination chemotherapy in a randomized phase III trial comparing to no further treatment in the medium and high-risk node negative stage I and stage II patients.
The key objective of the study is to prove that trabectedin (Yondelis) and PLD prolong overall survival versus carboplatin + PLD, in patients with progressive ovarian cancer 6 to 12 months after completing previous platinum based chemotherapy.As…
The primary objective of the phase I part of the study is to determine the recommended phase II dose of metformin in combination with carboplatin/paclitaxel chemotherapy in patients with advanced ovarian cancer. The secondary objectives the phase I…
The purpose of this study is to find out if the combination of gemcitabine plus carboplatin and iniparib works better than gemcitabine and carboplatin alone in subjects with stage IV squamous non-small-cell lung cancer (NSCLC) that have not…
To demonstrate that crizotinib (Arm A) is superior to first-line chemotherapy, pemetrexed/cisplatin or pemetrexed/carboplatin (Arm B), in prolonging PFS in patients with advanced non-squamous NSCLC whose tumors harbor a translocation or inversion…
PRIMARY OBJECTIVES Part I - To evaluate the efficacy (as measured by PFS) of GDC-0941 340 mg +carboplatin * paclitaxel (Arm A) versus carboplatin * paclitaxel (Arm B) in all patients with squamous NSCLC -To evaluate the efficacy (as measured by PFS…
Primary objectives:* Progression-free survival (PFS) defined as either of the following occurrences, whichever comes first:o PSA progression o Progressive disease according to RECIST when measurable diseaseSecondary objectives:* Toxicity profile.*…
Primary Objective:Part 1: To identify a dose of AMG 479 in combination with etoposide plus carboplatin and/or etoposide plus cisplatin, and of AMG 102 in combination with etoposide plus carboplatin and/or etoposide plus cisplatin that can be…
The primary objective is to select one of two platinum strategies to be used in this regimen for use as experimental arm in Phase III. This is a screening feasibility study addressing purely investigational approaches.
Primary: Safety run-in part (part 1):• Recommended Phase 3 dose regimen (RP3R) of canakinumab in combination with pembrolizumab plus chemotherapy. Double-blind, randomized, placebo-controlled part (part 2):• Progressive free survival (PFS) between…
Primary objective:-To assess the efficacy of durvalumab plus olaparib combination therapy compared with durvalumab monotherapy in terms of PFS (Investigator-assessed)Secondary objectives:- To further assess the efficacy of durvalumab plus olaparib…
PRIMARY OBJECTIVES*Rx-induction: Comparison of the 3 year EFS rate of 2 induction regimens, GPOH and RAPID COJEC, in patients with high-risk neuroblastoma.*Rx-HDC: Comparison of the 3 year EFS rate from randomization of single HDC with Bu-Mel versus…
The purpose of this study is to evaluate the safety, pharmacokinetics, and activity of GDC-6036 combined with other anti-cancer therapies in patients with previously untreated, advanced or metastatic non-small cell lung cancer (NSCLC) that harbors a…